PI: Monson, Brian Bruce Title: Auditory experience during the prenatal and perinatal period 

Received: 10/28/2019 FOA: PAR18-487 

Clinical Trial:Optional 

Council: 05/2020 

Competition ID: FORMS-E-REVISED FOA Title: NIDCD Early Career Research(ECR) Award (R21 - Clinical Trials 

Optional) 

1 R21 DC017820-01A1 Dual: Accession Number: 4367950 

IPF: 577704 Organization: UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN 

Former Number: Department: Speech and Hearing Science 

IRG/SRG: CDRC AIDS: N Expedited: N 

Subtotal Direct Costs 

(excludes consortium F&A) 

Year 1: 

Year 2: 

Year 3: 

Animals: N 

Humans: Y 

Clinical Trial: N 

Current HS Code: 30 

HESC: N 

HFT: N 

New Investigator: 

Early Stage Investigator: 

Senior/Key Personnel: Organization: Role Category: 

Brian Monson UNIVERSITY OF ILLINOIS AT 

URBANA-CHAMPAIGN 

PD/PI 

Derrick Rollo Carle Foundation Hospital Co-Investigator 

Carolyn Brown University of Iowa Consultant 

Sophie Ambrose Boys Town National Research Hospital Consultant 

Brittney Reidy University of Illinois at UrbanaChampaign Other (Specify)-Clinical Pediatric 

Audiologist 

Sa Shen University of Illinois at UrbanaChampaign Other (Specify)-Biostatistician 

Additions for Review 

Accepted Publication Articles accepted for 

publication since application 

submission 
 

 

OMB Number 4040-0001 

Expiration Date 10/31/2019 

APPLICATION FOR FEDERAL ASSISTANCE 

SF 424 (R&R) 

3. DATE RECEIVED BY STATE State Application Identifier 

1. TYPE OF SUBMISSION* 4.a. Federal Identifier 

R21DC017820

❍ Pre-application ● Application ❍ Changed/Corrected 

Application 

b. Agency Routing Number 

2. DATE SUBMITTED Application Identifier c. Previous Grants.gov Tracking Number 

5. APPLICANT INFORMATION Organizational DUNS*: 

Legal Name*: UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN

Department: 

Division: 

Street1*: Sponsored Programs Administration

Street2: 

City*: 

County: 

State*: 

Province: 

Country*: USA: UNITED STATES

ZIP / Postal Code*: 

Person to be contacted on matters involving this application 

Prefix: First Name*: Robin Middle Name: Last Name*: Beach Suffix: 

Position/Title: 

Street1*: 

Street2: 

City*: 

County: 

State*: 

Province: 

Country*: USA: UNITED STATES

ZIP / Postal Code*: 

Phone Number*: Fax Number: Email: 

6. EMPLOYER IDENTIFICATION NUMBER (EIN) or (TIN)* 

7. TYPE OF APPLICANT* H: Public/State Controlled Institution of Higher Education

Other (Specify): 

Small Business Organization Type ❍ Women Owned ❍ Socially and Economically Disadvantaged 

8. TYPE OF APPLICATION* 

❍ New ● Resubmission 

❍ Renewal ❍ Continuation ❍ Revision 

If Revision, mark appropriate box(es). 

❍ A. Increase Award ❍ B. Decrease Award ❍ C. Increase Duration 

❍ D. Decrease Duration ❍ E. Other (specify) :

Is this application being submitted to other agencies?* ❍Yes ●No What other Agencies? 

9. NAME OF FEDERAL AGENCY* 

National Institutes of Health

10. CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER 

TITLE: 

11. DESCRIPTIVE TITLE OF APPLICANT'S PROJECT* 

Auditory experience during the prenatal and perinatal period

12. PROPOSED PROJECT 13. CONGRESSIONAL DISTRICTS OF APPLICANT 

Start Date* Ending Date* 

07/01/2020 06/30/2023

Funding Opportunity Number: PAR-18-487 . Received Date: Tracking Number: GRANT12962231 2019-10-28T12:08:58.000-04:00 Page 1 
 

 

Contact PD/PI: Monson, Brian Bruce 

SF 424 (R&R) APPLICATION FOR FEDERAL ASSISTANCE Page 2 

14. PROJECT DIRECTOR/PRINCIPAL INVESTIGATOR CONTACT INFORMATION 

Prefix: First Name*: Brian Middle Name: Bruce Last Name*: Monson Suffix: 

Position/Title: Assistant Professor

Organization Name*: UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN

Department: Speech and Hearing Science

Division: 

Street1*: 

Street2: 

City*: 

County: 

State*: 

Province: 

Country*: USA: UNITED STATES

ZIP / Postal Code*: 

Phone Number*: Fax Number: Email*: 

15. ESTIMATED PROJECT FUNDING 

a. Total Federal Funds Requested* 

b. Total Non-Federal Funds* 

c. Total Federal & Non-Federal Funds* 

d. Estimated Program Income* 

16. IS APPLICATION SUBJECT TO REVIEW BY STATE 

EXECUTIVE ORDER 12372 PROCESS?* 

a. YES ❍ THIS PREAPPLICATION/APPLICATION WAS MADE 

AVAILABLE TO THE STATE EXECUTIVE ORDER 12372 

PROCESS FOR REVIEW ON: 

DATE: 

b. NO ● PROGRAM IS NOT COVERED BY E.O. 12372; OR 

❍ PROGRAM HAS NOT BEEN SELECTED BY STATE FOR 

REVIEW 

17. By signing this application, I certify (1) to the statements contained in the list of certifications* and (2) that the statements herein 

are true, complete and accurate to the best of my knowledge. I also provide the required assurances * and agree to comply with 

any resulting terms if I accept an award. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to 

criminal, civil, or administrative penalties. (U.S. Code, Title 18, Section 1001) 

● I agree* 

* The list of certifications and assurances, or an Internet site where you may obtain this list, is contained in the announcement or agency specific instructions. 

18. SFLLL or OTHER EXPLANATORY DOCUMENTATION File Name: 

19. AUTHORIZED REPRESENTATIVE 

Prefix: First Name*: Avijit Middle Name: Last Name*: Ghosh Suffix: 

Position/Title*: Comptroller

Organization Name*: University of Illinois at Urbana-Champaign

Department: Sponsored Programs

Division: 

Street1*: 

Street2: 

City*: 

County: 

State*: 

Province: 

Country*: USA: UNITED STATES

ZIP / Postal Code*: 

Phone Number*: Fax Number: Email*: 

Signature of Authorized Representative* Date Signed* 

Brad Johnson 10/28/2019

20. PRE-APPLICATION File Name: 

21. COVER LETTER ATTACHMENT File Name:CoverLetter.pdf

Tracking Number: GRANT12962231 Funding Opportunity Number: PAR-18-487 . Received Date: 

Page 2 2019-10-28T12:08:58.000-04:00 
Contact PD/PI: Monson, Brian Bruce 

424 R&R and PHS-398 Specific 

Table Of Contents 

SF 424 R&R Cover Page 1 

Table of Contents 3 

Performance Sites 4 

Research & Related Other Project Information 5 

Project Summary/Abstract(Description) 6 

Project Narrative 7 

Facilities & Other Resources 8 

Equipment 11 

Research & Related Senior/Key Person 12 

PHS398 Cover Page Supplement 38 

PHS 398 Modular Budget 40 

Personnel Justification 44 

Consortium Justification 45 

PHS 398 Research Plan 46 

Introduction to Application 47 

Specific Aims 48 

Research Strategy 49 

PHS Human Subjects and Clinical Trials Information 55 

Study 1: Auditory experience during the prenatal and perinatal period 57 

Inclusion Enrollment Reports 62 

Bibliography & References Cited 71 

Consortium/Contractual Arrangements 75 

Letters of Support 76 

Resource Sharing Plan(s) 79 

Table of Contents Page 3 
Contact PD/Pl: Monson, Brian Bruce 

0MB Number: 4040-0010 

Expiration Date: 10/31/2019 

Project/Performance Site Location(s) 

Project/Performance Site Primary Location O I am submitting an application as an individual, and not on behalf of 

a company, state, local or tribal government, academia, or other type of 

organization. 

Organization Name: 

UNIVERSITY OF ILLINOIS AT URBANACHAMPAIGN 

Duns Number: 

Street1•: 

Street2: 

City•: 

S

Co

ta

un

te•

ty

: 

: 

-

P

Co

rov

un

in

try

ce

•: 

: 

-

USA: UNITED STATES 

Zip / Postal Code•: 

Project/Performance Site Co

-

ngressional Districr: 

Project/Performance Site Location 1 

Organization Name: Carle Foundation Hospital 

DUNS Number: 

Street1•: 

Street2: 

City•: 

S

Co

ta

un

te•: 

ty: 

-

P

Co

rov

un

in

try•

ce: 

: 

-

USA: UNITED STATES 

Zip / Postal Code•: 

Project/Performance Site Co

-

ngressional Districr: 

Additional Location(s) File Name: 

Tracking Number: GRANT1 2962231 

11111 

O I am submitting an application as an individual, and not on behalf of 

a company, state, local or tribal government, academia, or other type of 

organization. 

1111 

Page4 Funding Opportunity Number: PAR-18-487. Received Date: 

2019-10-28T12:08:58.000-04:00 
Contact PD/PI: Monson, Brian Bruce 

OMB Number: 4040-0001

Expiration Date: 10/31/2019

RESEARCH & RELATED Other Project Information

1. Are Human Subjects Involved?* ● Yes ❍ No 

1.a. If YES to Human Subjects 

Is the Project Exempt from Federal regulations? ❍ Yes ● No 

If YES, check appropriate exemption number: 1 2 3 4 5 6 7 8 

If NO, is the IRB review Pending? ❍ Yes ● No 

IRB Approval Date: 11-14-2018

Human Subject Assurance Number 00008584

2. Are Vertebrate Animals Used?* ❍ Yes ● No 

2.a. If YES to Vertebrate Animals 

Is the IACUC review Pending? ❍ Yes ❍ No 

IACUC Approval Date: 

Animal Welfare Assurance Number 

3. Is proprietary/privileged information included in the application?* ❍ Yes ● No 

4.a. Does this project have an actual or potential impact - positive or negative - on the environment?* ❍ Yes ● No 

4.b. If yes, please explain: 

4.c. If this project has an actual or potential impact on the environment, has an exemption been authorized or an ❍ Yes ❍ No 

environmental assessment (EA) or environmental impact statement (EIS) been performed? 

4.d. If yes, please explain: 

5. Is the research performance site designated, or eligible to be designated, as a historic place?* ❍ Yes ● No 

5.a. If yes, please explain: 

6. Does this project involve activities outside the United States or partnership with international ❍ Yes ● No 

collaborators?* 

6.a. If yes, identify countries: 

6.b. Optional Explanation: 

Filename 

7. Project Summary/Abstract* Project_Summary.pdf

8. Project Narrative* Project_Narrative.pdf

9. Bibliography & References Cited Bibliography.pdf

10.Facilities & Other Resources Facilities_and_Other_Resources.pdf

11.Equipment Equipment.pdf

Page 5 

Funding Opportunity Number: PAR-18-487. Received Date: Tracking Number: GRANT12962231 2019-10-28T12:08:58.000-04:00 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contact PD/PI: Monson, Brian Bruce 

Within the United States alone, over a half-million infants are born premature each year. While medical 

advances have dramatically improved survival rates, long-term morbidities related to auditory function are 

common. The preterm population suffers from a relatively high prevalence of sensorineural hearing loss, 

auditory neuropathy/dys-synchrony, and central auditory processing disorder. Even preterm infants in whom no 

specific auditory pathology has been diagnosed exhibit cognitive impairments related to auditory processing, 

including auditory attention deficits, language processing deficits, and other speech/language communication 

deficits. Despite these facts, a solid understanding of the impact of premature birth on auditory 

neurodevelopment is lacking. Possible effects of the acoustic environment are unknown. The long-term 

objective of this research is to characterize the effect of premature birth on auditory neurodevelopment and 

communication behavior to aid in improving best medical practices and therapeutic interventions for preterm 

infants. In this study, we propose to measure the effects of auditory input during the preterm period on 

neurodevelopmental outcomes. There are three specific aims. In Aim 1 we will recruit a cohort of preterm 

infants in the neonatal intensive care unit (NICU) to prospectively measure their auditory input during hospital 

stay. We will quantify detailed auditory experience in the NICU and determine how this differs from intrauterine 

auditory experience. In Aim 2 we will determine the effect of premature birth on auditory function at 3 months of 

age. In Aim 3 we will determine the relationship between our measured parameters of perinatal auditory 

experience and auditory function in infancy. The proposed study will lay the foundation for a longitudinal study 

aimed to determine the effect of auditory experience in the NICU on long-term auditory and language 

development. Valuable insight will be gained as to how premature birth and NICU environment might affect 

auditory neurodevelopment. Results of these studies will ultimately aid in identifying (1) effective interventions 

to optimize NICU auditory experience and (2) potential early-intervention therapies for NICU infants at greatest 

risk for auditory and language deficits later in childhood. 

Project Summary/Abstract Page 6 
 

 

 

 

Contact PD/PI: Monson, Brian Bruce 

Within the United States alone, over 500,000 infants are born preterm each year, with survivors commonly 

suffering from cognitive disorders and auditory neurodevelopmental disorders. This research will provide 

valuable insight as to how premature birth, medical care, and sounds in the neonatal intensive care unit affect 

brain development in preterm infants. 

Project Narrative Page 7 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contact PD/PI: Monson, Brian Bruce 

FACILITIES AND OTHER RESOURCES 

University of Illinois at Urbana-Champaign (UIUC) 

The University of Illinois at Urbana-Champaign (UIUC), located in east central Illinois, is home to over 50,000 

students and nearly 3,000 faculty members. UIUC holds the Carnegie classification of Highest Research 

Activity and in the 2020 U.S. News & World Report's America's Best Colleges was ranked as the number 14 

public university. 

As one of 15 colleges and instructional units housed at UIUC, the College of Applied Health Sciences has the 

mission to, “advance research, instruction and public engagement that promotes the development of healthy, 

livable communities, facilitates optimal living with disability and promotes health and wellness across the 

lifespan and throughout a diverse society.” Within the college, the Center on Health, Aging, and Disability 

(CHAD) works to further this mission by supporting faculty research on these topics in a variety of ways 

including technical support for qualitative and quantitative research, educational opportunities with regard to 

grantsmanship, and acting as a liaison to the local community, specifically through their continued support of 

the Age-Friendly Champaign-Urbana effort. 

Situated in the heart of the midwest and its rich history in communication sciences, the UIUC Department of 

Speech and Hearing Science is accredited by the Council of Academic Accreditation of the American 

Speech-Language-Hearing Association and boasts a top-20 ranking for graduate schools in speech language 

pathology. The department is home to many NIH- and other externally-funded investigators directing 

research programs spanning the broad spectrum of communication sciences and disorders. 

Technological Infrastructure 

Advanced digital services are provided by Technology Services. Network resources that support the 

proposed project include category six (6) wiring with 100MB or 1Gb connectivity provided to all desktop 

computers (PC or Apple) and Wi-Fi (802.11 a/b/g/n) in all campus buildings and meeting rooms to connect 

computers and mobile devices. The computer network backbone offers a strong 10Gb bandwidth. The 

campus participates in the Internet2, MREN, and ESnet networks. 

The Office of Information, Security and Technology (OIST) from the College of Applied Health Sciences 

checks that all necessary software is installed on all computers and includes Microsoft Office, forefront virus 

protection, Adobe Acrobat Suite (including Pro and Reader) along with desktop security and anti-malware 

software. An extensive IT support staff maintains all the computers, the computer network, constantly 

investigates on technology trends and maintains college wide services such as survey platforms, statistical 

processing software and online collaboration tools. In addition to project desktop-computing systems, daily 

backed up virtual machines and storage spaces are available to the project along with Webservers with Web 

Services support and are provided by College IT staff. 

In terms of security and ability to handle medical health information, OIST provides guidance and support to 

facilitate the installation, configuration, and operation of UIUC-Amazon HIPAA virtual machine and storage. In 

addition, among OIST’s functionality is adequate support and physical space for video production and editing. 

Online collaboration tools are part of the technology assets that OIST offers to the project, such as 

BlackBoard Collaborate and RedCap, which will be instrumental in enabling and supporting interaction and 

data sharing among members of the project. 

Conference and meeting facilities for the proposed project are provided by CHAD and the College of Applied 

Health Sciences. They include two regular conference rooms with dedicated AV projector systems. One 

videoconference room with a Tandberg 6000MXP IP (H.323) videoconference system that includes high-end 

performance features, dual large flatscreen monitors, dual TANDBERG Precision HD Cameras and CDquality, stereo audio. An additional workshop facility provide seating 35 and contains a dedicated computer, 

document camera, and projector system along with an advanced Media:Scape collaborator desk system 

providing dual screen HD videoconferencing collaboration across the table with connection to teams across 

the globe. 

Facilities & Other Resources Page 8 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contact PD/PI: Monson, Brian Bruce 

CHAD also provides an enhanced “high end” poster printer (HP Designjet Z6200) for use by all AHS faculty. 

The poster printer is located in the Center on Health, Aging and Disability Main Office. 

Biostatistical Services 

CHAD provides research biostatistical support to all Applied Health Sciences faculty. The Research 

Biostatistician position is a twelve-month full-time position. The Research Biostatistician consults with 

individual faculty and investigative research teams as to appropriate research design, power analyses, and 

statistical approaches for grant applications, ongoing research projects and preliminary studies. Research 

biostatistician is located in CHAD and reports to the Director of the Center. Infrastructure support includes MS 

Office, Adobe Pro and full licenses to SPSS, SAS, M Plus, S Plus, DBMS File Transfer (Oracle) and 

MATLAB. 

Laboratory 

The PI has an office and laboratory space on UIUC campus. The lab holds a large 8 ft × 16 ft double-walled 

sound-treated booth that can be used for audiological testing, and is currently equipped for speech 

perception testing and psychoacoustics experiments. The lab has four computer workstations with acoustical 

analysis software. There is a LENA dedicated computer to run the LENA software and classification 

algorithm. There is currently 10 TB of upgradable storage on an encrypted and password-protected server for 

the LENA data storage. 

Carle Foundation Hospital 

The Carle Foundation Hospital has been engaged in clinical research for over 20 years and has a strong clinical 

research program facilitated by the Stephens Family Clinical Research Institute (SFCRI). The SFCRI includes 

eight individual research centers that focus on many different aspects of health and clinical research. The 

SFCRI employs full-time research staff to assist in all stages of research, including development of the 

proposal, institiutional review board application development, recruitment of subjects, and execution of the data 

collection plan. 

Carle Foundation Hospital has a 48-bed Level III neonatal intensive care unit (NICU) with a newly constructed 

separate small baby unit for infants born <28 weeks’ gestation. The NICU physician and nursing staff have 

collaborated on multiple past and current research projects with investigators at UIUC. Relevant for the present 

study, Carle hospital averages over 120 very preterm infant (i.e., born < 32 weeks’ gestation) admissions per 

year. Families of very preterm infant patients will be recruited through the Carle NICU. The PI and Co-I have 

access to the expertise and insight of the clinicians and nurses who regularly provide health care to these 

patients. 

The PI’s lab and the Carle Hospital are within 10 blocks of each other (less than 5 min drive). 

Audiology Clinic 

The Speech and Hearing Science Department is home to the Audiology Clinic where the pediatric audiological 

assessments in this proposal will be conducted. The clinic has two double-walled sound-treated booths and 

equipment for conducting all standard audiological assessments. 

Resources for Early Stage Investigators 

The University, College, and Department offer a substantial number of institutional resources for junior faculty. 

Examples at the university level include a grant writing seminar series with mentored feedback and mock 

review, and campus research grant opportunities. The UIUC Center for Innovation in Teaching and Learning 

offers regular seminars and workshops, as well as individual consultations, for improving classroom teaching. 

The college’s CHAD holds frequent seminars focused on the promotion and tenure process, provides travel 

awards, and offers research grants to support collection of pilot data. Departmental support includes 40% 

protected research time, resources for classes, and a formal mentoring program within the department. 

Intellectual Environment 

The Champaign-Urbana community provides a rich intellectual environment. Relevant to the present study, 

there are researchers who study pediatric speech perception for hearing-impaired children (Dr. Karen Kirk, 

Speech and Hearing Science), language development (Dr. Pamela Hadley, Speech and Hearing Science), 

Facilities & Other Resources Page 9 
 

 

Contact PD/PI: Monson, Brian Bruce 

infant cognition (Dr. Renee Baillargeon, Psychology), and language acquisition (Dr. Cynthia Fisher, 

Psychology). The PI is part of an active auditory neuroscience journal club with regular interaction among 

researchers across campus (Dr. Fatima Husain, Speech and Hearing Science; Dr. Jont Allen, Engineering; Dr. 

Dan Llano, Molecular and Cellular Biology). Additionally, the Speech and Hearing Science Department hosts 

bi-weekly proseminars with both internal and external invited scholars. 

A number of mechanisms to support interdisciplinary collaboration exist at UIUC. The Interdisciplinary Health 

Sciences Institute facilitates the collaboration of researchers in health sciences and technology. CHAD 

facilitates collaboration within and across colleges, and organizes regular interdisplinary symposiums. The 

Beckman Institute fosters interdisciplinary work throughout the university, including researchers in physical 

sciences, computation, engineering, biology, behavioral sciences, cognition, and neuroscience. 

Facilities & Other Resources Page 10 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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EQUIPMENT 

The equipment necessary for the LENA data collection is currently in place in Dr. Monson’s laboratory, 

including 30 LENA recorders with 24-hr, multi-day recording capability, recorder chargers, and the LENA SP 

software license. The cloud-based LENA software executes the automated classification algorithm, providing 

tabulation of different sound category durations for daily, hourly, and 5-minute increments for the recording 

period. The software also includes an advanced data extraction (ADEX) program that provides additional detail 

on the recording, including calibrated average and peak sound pressure levels, as well as tabulations for 

subcategories of sounds (e.g., female language, male language, target child vocalizations, non-target child 

vocalizations). With 30 LENA recorders, we have the capacity to enroll 15 preterm infants and 15 pregnant 

women concurrently. The auditory exposure data collection period is 8 to 12 weeks, giving us capacity to 

collect data from at least 60 subjects per group annually (i.e., 15 subjects per quarter per group). 

In Dr. Monson’s laboratory there are four Apple computer workstations outfitted with dual-core Intel Core i5 

processors and software packages for acoustical analysis (MATLAB, Audacity, Praat) and statistical analysis 

(R). A lab-dedicated, encrypted, password-protected network server managed by the college’s Office of 

Information, Security and Technology currently provides 10.0 terabytes of storage, upgradable to more storage 

if needed. The laboratory also holds a large 8 ft x 16 ft double-walled sound-treated booth that can be used for 

audiological testing, and is currently equipped for speech perception testing and psychoacoustics experiments. 

The Audiology Clinic has two double-walled sound-treated booths for conducting all standard audiological 

assessments. The clinic equipment available for this proposal includes a GSI Tympstar V2 and GSI 39 for 

tympanometry and screening; a Bio-Logic Scout for otoacoustic emissions; a Bio-Logic Navigator Pro and 

Intelligent Hearing Systems Duet for auditory brainstem responses; a GSI 62 Clearview video otoscope; two 

GSI 61 audiometers; and Etymotic 3A insert earphones. 

Equipment Page 11 
Contact PD/PI: Monson, Brian Bruce OMB Number: 4040-0001 

Expiration Date: 10/31/2019 

RESEARCH & RELATED Senior/Key Person Profile (Expanded)

PROFILE - Project Director/Principal Investigator

Prefix:  First Name*: Brian Middle Name Bruce Last Name*: Monson

Position/Title*: Assistant Professor

Organization Name*: UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN

Department: Speech and Hearing Science

Division:

Street1*:

Street2:

City*:

County:

State*:

Province:

Country*: USA: UNITED STATES

Zip / Postal Code*:

Suffix: 

Phone Number*:  Fax Number: 

E-Mail*: 

Credential, e.g., agency login: 

Project Role*:  PD/PI Other Project Role Category: 

Degree Type:  PHD,MS,BS Degree Year:  2011,2006,2003

Attach Biographical Sketch*: File Name: Biosketch_Monson.pdf

Attach Current & Pending Support: File Name:

Page 12 

Funding Opportunity Number: PAR-18-487 . Received Date: Tracking Number: GRANT12962231 2019-10-28T12:08:58.000-04:00 
Contact PD/PI: Monson, Brian Bruce 

PROFILE - Senior/Key Person

Prefix:  First Name*: Derrick Middle Name 

Position/Title*: Physician, Neonatology

Organization Name*: Carle Foundation Hospital

Department:

Division:

Street1*:

Street2:

City*:

County:

State*:

Province:

Country*: USA: UNITED STATES

Zip / Postal Code*:

Last Name*: Rollo Suffix: 

Phone Number*: 

E-Mail*: 

Fax Number: 

Credential, e.g., agency login: 

Project Role*:  Co-Investigator Other Project Role Category: 

Degree Type:  D.O. Degree Year:  2006

Attach Biographical Sketch*: File Name: Biosketch_Rollo.pdf

Attach Current & Pending Support: File Name:

PROFILE - Senior/Key Person

Prefix:  First Name*: Carolyn Middle Name J Last Name*: Brown

Position/Title*: Professor

Organization Name*: University of Iowa

Department:

Division:

Street1*:

Street2:

City*:

County:

State*:

Province:

Country*: USA: UNITED STATES

Zip / Postal Code*:

Suffix: 

Phone Number*:  Fax Number: 

E-Mail*: 

Credential, e.g., agency login: 

Project Role*:  Consultant Other Project Role Category: 

Degree Type:  PHD,MA,BA Degree Year:  1989,1982,1980

Attach Biographical Sketch*: 

Attach Current & Pending Support: 

File Name:

File Name:

Biosketch_Brown.pdf

Tracking Number: GRANT12962231 

Page 13 

Funding Opportunity Number: PAR-18-487 . Received Date: 

2019-10-28T12:08:58.000-04:00 
Contact PD/PI: Monson, Brian Bruce 

PROFILE - Senior/Key Person

Prefix:  First Name*: Sophie Middle Name E. Last Name*: Ambrose

Position/Title*: Director, Communication Development Lab

Organization Name*: Boys Town National Research Hospital

Department:

Division:

Street1*:

Street2:

City*:

County:

State*:

Province:

Country*: USA: UNITED STATES

Zip / Postal Code*:

Suffix: 

Phone Number*:  Fax Number: 

E-Mail*

Credential, e.g., agency login: 

Project Role*:  Consultant Other Project Role Category: 

Degree Type:  PHD,MA,BS Degree Year:  2009,2006,2002

Attach Biographical Sketch*: File Name: Biosketch_Ambrose.pdf

Attach Current & Pending Support: File Name:

PROFILE - Senior/Key Person

Prefix:  First Name*: Brittney Middle Name Danielle- Last Name*: Reidy Suffix: 

Baird

Position/Title*: Clinical Assistant Professor

Organization Name*: University of Illinois at Urbana-Champaign

Department:

Division:

Street1*:

Street2:

City*:

County:

State*:

Province:

Country*: USA: UNITED STATES

Zip / Postal Code*:

Phone Number*:  Fax Number: 

E-Mail*: 

Credential, e.g., agency login: 

Project Role*:  Other (Specify) Other Project Role Category: Clinical Pediatric Audiologist

Degree Type:  AuD Degree Year:  2012

Attach Biographical Sketch*: 

Attach Current & Pending Support: 

File Name:

File Name:

Biosketch_Reidy.pdf

Tracking Number: GRANT12962231 

Page 14 

Funding Opportunity Number: PAR-18-487 . Received Date: 

2019-10-28T12:08:58.000-04:00 
Contact PD/PI: Monson, Brian Bruce 

PROFILE - Senior/Key Person

Prefix:  First Name*: Sa Middle Name  Last Name*: Shen

Position/Title*: Director of Biostatistical Services

Organization Name*: University of Illinois at Urbana-Champaign

Department:

Division:

Street1*:

Street2:

City*:

County:

State*:

Province:

Country*: USA: UNITED STATES

Zip / Postal Code*:

Suffix: 

Phone Number*:  Fax Number: 

E-Mail*: 

Credential, e.g., agency login: 

Project Role*:  Other (Specify) Other Project Role Category: Biostatistician

Degree Type:  Ph.D. Degree Year:  1997

Attach Biographical Sketch*: File Name: Biosketch_Shen.pdf

Attach Current & Pending Support: File Name:

Page 15 

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OMB No. 0925 0001 and 0925 0002 (Rev. 09/17 Approved Through 03/31/2020) 

BIOGRAPHICAL SKETCH 

Prov de the fo ow ng nformat on for the Sen or/key personne and other s gn f cant contr butors. 

Fo ow th s format for each person. DO NOT EXCEED FIVE PAGES. 

NAME: Brian Bruce Monson 

eRA COMMONS USER NAME (credential, e.g., agency login): 

POSITION TITLE: Assistant Professor 

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, 

include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) 

INSTITUTION AND LOCATION 

DEGREE 

(if 

applicable) 

Completion 

Date 

MM/YYYY 

FIELD OF STUDY 

Utah State University, Logan, UT 

Brigham Young University, Provo, UT 

University of Arizona, Tucson, AZ 

Duke-NUS Graduate Medical School, Singapore 

Brigham & Women’s Hospital, Harvard Medical 

School, Boston, MA 

B.S. 

M.S. 

Ph.D. 

Postdoc 

Postdoc 

08/2003 

08/2006 

08/2011 

12/2013 

05/2016 

Electrical Engineering 

Physics (Acoustics) 

Speech, Language, 

Hearing Science 

Neuroscience 

Pediatric Newborn 

Medicine 

A. Personal Statement 

I am an auditory neuroscientist and acoustician. I am also the director of the Auditory Neuro Experience 

Lab at the University of Illinois at Urbana-Champaign, where we seek to understand how auditory experience 

over ontogeny and phylogeny shapes the human brain. By virtue of my interdisciplinary training, I am well 

suited to carry out the proposed study on auditory exposures for neonates. I have the expertise to measure 

and understand the complex differences between the acoustic environments of the womb (where sounds 

consist largely of maternal vocal, cardiovascular, and digestive sounds transmitted through amniotic fluid) and 

of the neonatal intensive care unit (NICU; where sounds consist of mechanical and electronic noise, alarms, 

and often loud conversation transmitted through air). From my years as a researcher at a well-established 

research hospital, I bring experience measuring NICU acoustics and conducting collaborative, longitudinal, 

clinical research with NICU infants. My previous theoretical work modeling the role of experience (over 

phylogeny and ontogeny) in the development of sensory neural circuitry informs my hypotheses of how 

different auditory exposures could affect brain development. My work in speech perception provides 

foundational understanding of principles governing typical and atypical neural processing of speech and 

language. 

Due to family care responsibilities, including three childbirths between 2015-2017 and care for a child 

diagnosed with special needs in 2015, years 2015-2017 were less productive for me. 

B. Positions and Honors 

Positions and Employment 

2002 Audio Engineer, IVIE Technologies, Inc., Lehi, UT 

2002-2003 Sound Engineer, Eclipse, Inc., Logan, UT 

2003-2006 Research Assistant, Physics Department, Brigham Young University, Provo, UT 

2004 Instructor, Physics Department, Brigham Young University, Provo, UT 

2005 Noise Control Consultant, Orem City Public Works, UT 

2005-2006 Research Consultant, Samuel Fletcher, Provo, UT 

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2006-2009 Predoctoral Research Fellow, Speech/Language/Hearing Sciences Department, University of 

Arizona, Tucson, AZ 

2008 Instructor, Speech/Language/Hearing Sciences Department, University of Arizona, Tucson, 

AZ 

2008 Visiting Researcher, Speech/Music/Hearing Group, Royal Institute of Technology, Stockholm, 

Sweden 

2009-2011 Research Associate, National Center for Voice and Speech, University of Utah, Salt Lake City, 

UT 

2011-2013 Research Fellow, Neuroscience and Behavioral Disorders Department, Duke-NUS Graduate 

Medical School, Singapore 

2013 Lecturer, Electrical Engineering and Psychology Departments, National University of 

Singapore, Singapore 

2014-2015 Postdoctoral Research Fellow, Pediatric Newborn Medicine Department, Brigham and 

Women’s Hospital, Boston, MA 

2014-2015 Research Fellow, Department of Radiology, Children’s Hospital Boston, Boston, MA 

2014-2016 Research Fellow in Pediatrics, Harvard Medical School, Boston, MA 

2015-2017 Research Scientist, Pediatric Newborn Medicine Department, Brigham and Women’s Hospital, 

Boston, MA 

2015-2017 Affiliate Research Scientist, Department of Radiology, Children’s Hospital Boston, Boston, MA 

2016-2017 Instructor in Pediatrics, Harvard Medical School, Boston, MA 

2017- Assistant Professor, Department of Speech and Hearing Science, University of Illinois at 

Urbana-Champaign, IL 

Other Experience and Professional Memberships 

Memberships 

2000- Institute of Electrical and Electronics Engineers (IEEE) 

2002- Tau Beta Pi (Engineering Honor Society) 

2003- Acoustical Society of America 

2014- Association for Research in Otolaryngology 

Service 

2004-2006 Member, Acoustical Society of America Student Council 

2005 Founder, BYU Student Chapter, Acoustical Society of America 

2005-2006 Chair, BYU Student Chapter Executive Council, Acoustical Society of America 

2005-2007 Chair, Acoustical Society of America Student Council 

2006- Ad-hoc reviewer: Proceedings of the National Academy of Sciences; Brain; Human Brain 

Mapping; NeuroImage; Attention, Perception, and Psychophysics; Trends in Hearing; Ear and 

Hearing; Journal of the Acoustical Society of America; Journal of Speech, Language, and 

Hearing Research; Journal of Voice; Frontiers in Neuroscience; Frontiers in Psychology 

2014-2016 Member, Governing Board, Harvard Medical Postdoc Association 

2014-2016 Chair, Advocacy Subcommittee, Harvard Medical Postdoc Association 

2014 Member, Organizing Committee, Future of Research Symposium, Boston, MA 

2014-2016 Member, Advocacy Committee, National Postdoc Association 

2015- Member, Education in Acoustics Committee, Acoustical Society of America 

2019 Symposium Co-organizer, Midwinter Meeting, Association for Research in Otolaryngology 

Honors and Awards 

2000-2003 Presidential Scholarship (Academic), Utah State University, Logan, UT 

2002 Tau Beta Pi inductee, Utah Gamma Chapter, Logan, UT 

2003 Graduate Cum Laude in Electrical Engineering, Utah State University, Logan, UT 

2003-2006 Physics and Astronomy Scholarship (Academic), Brigham Young University, Provo, UT 

2004 Young Presenter Award, Acoustical Society of America 

2006 Conference Travel Award, Society for Education, Music, and Psychology Research 

2006 Research Presentation Award, Graduate Studies, Brigham Young University, Provo, UT 

2006-2009 Fellowship, Center for Science, Medicine, and the Performing Arts, Dept of Speech, 

Language, and Hearing Sciences, University of Arizona, Tucson, AZ 

2007 Best Student Paper Award (First Prize), Acoustical Society of America 

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2009 Galileo Circle Scholar Award, College of Science, University of Arizona, Tucson, AZ 

2009 Travel Award, Graduate and Professional Student Council, University of Arizona, Tucson, AZ 

2010-2011 National Research Service Award (Individual Predoctoral), NIH, NIDCD (F31DC010533) 

2010 Fellow, Lessons for Success Research Workshop, American Speech-Language-Hearing 

Association (ASHA) and NIDCD 

2010 Travel Award, Graduate and Professional Student Council, University of Arizona, Tucson, AZ 

2012 Best Student Paper Award (First Prize), Acoustical Society of America 

2012 Young Investigator Travel Award, Acoustical Society of America 

2015 Selected Attendee, Postdoc Leadership Workshop, Harvard Medical School, Boston, MA 

2015 Travel Award, Auditory Development: From Cochlea to Cognition Meeting, Seattle, WA 

2016 Travel Award, Early-career Acousticians Retreat, Acoustical Society of America 

2018 List of Teachers Ranked as Excellent, University of Illinois at Urbana-Champaign, IL 

2019 List of Teachers Ranked as Excellent, University of Illinois at Urbana-Champaign, IL 

C. Contributions to Science 

1. My recent work has examined the effect of premature birth on human auditory neurodevelopment. Previous 

work measuring cortical responses suggested that preterm birth is associated with atypical development of 

auditory cortical processing in infancy, but the responsible neural underpinnings remain unknown. I used 

diffusion MRI to (1) characterize the maturational timeline of left hemisphere primary and secondary 

auditory cortex in Heschl’s gyrus for preterm infants and (2) assess the effect of prematurity on primary and 

secondary auditory cortical microstructure in infancy. By comparing with term-born controls, I demonstrated 

that both gray and white matter located in Heschl’s gyrus in preterm infants exhibit significant 

microstructural changes that are indicative of lower tissue density. Results were consistent with a delay in 

maturation of primary and nonprimary auditory cortex. Disrupted maturation in infancy was associated with 

poorer language ability at longitudinal follow-up. Following on this work, I have also conducted studies 

assessing the differences between the acoustical environments of the NICU and the womb. I found that 

NICU incubators attenuate sound substantially more than attenuations reported for sounds passing into the 

intrauterine environment. I have reported the latter findings in conference abstracts and a submitted 

manuscript that is currently under revision. 

a. Monson BB, Eaton-Rosen Z, Kapur K, Liebenthal E, Brownell A, Smyser CD, Rogers CE, Inder TE, 

Warfield SK, and Neil JJ (2018) Differential rates of perinatal maturation of human primary and 

nonprimary auditory cortex. eNeuro, 5(1) e0380-17.2017, 1-12. PMCID: PMC5773280 

b. Monson BB, and Cull M (2019) Average daily speech exposure for fetuses. Journal of the 

Acoustical Society of America, 145 (3), 1767. 

c. Monson BB (2017) The auditory experience of infants born prematurely. Journal of the Acoustical 

Society of America, 141 (5), 3694. 

2. While cross-sectional MRI studies have shown that very preterm infants exhibit lower gray and white matter 

volumes in infancy compared to healthy term-born controls, longitudinal data are lacking. In a prospective 

observational, longitudinal, cohort study that included 220 preterm infants, brain volumes (cortical gray 

matter, white matter, subcortical gray matter) were measured at the time of discharge from the hospital and 

age 7 years. My collaborators and I showed that low brain volumes observed in preterm infants were 

exaggerated at 7 years, suggesting that infants don’t show “catch up” brain growth. Low brain volume in 

infancy was also associated with worse long-term outcomes in IQ, language, and motor functioning. These 

results indicate that outcome is already largely determined when the preterm infant goes home from the 

hospital and emphasize the need for optimizing brain development prior to discharge from the NICU. This 

was the first longitudinal examination of brain growth between infancy and childhood in this population. 

a. Monson BB, Anderson PJ, Matthews L, Neil JJ, Kapur K, Cheong J, Doyle LW, Thompson DK, and 

Inder TE (2016) Examination of the pattern of growth of cerebral tissue volumes from hospital 

discharge to early childhood in very preterm infants. JAMA Pediatrics, 170(8), 772-779. PMCID: 

PMC5773280 

b. Matthews LGF, Inder TE, Pascoe L, Kapur K, Lee KJ, Monson BB, Doyle LW, Thompson DK, and 

Anderson PJ (2018) Longitudinal preterm cerebellar volume: perinatal and neurodevelopmental 

outcome associations. Cerebellum, 17(5), 610-627. PMCID: PMC6126980 

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3. My research in speech perception has focused on the question of how normal-hearing humans perceive 

very high-frequency sounds that are produced during speech, but that are inaudible to those with highfrequency hearing loss. Current cochlear implants and hearing aids restore auditory information critical to 

successful communication, allowing the hearing-impaired to function well in society. Nonetheless, users 

often complain of communication difficulties in noisy situations, suggesting a need to improve the 

technology. My research has shown that energy at extended high frequencies (> 8 kHz), which is not 

reproduced or represented well by current hearing aids or cochlear implants, contains information useful for 

making speech more intelligible in challenging listening environments. Our findings suggest accurate 

representation of high frequencies in communication devices could improve the user’s overall experience. 

a. Monson BB, Rock J, Schulz A, Hoffman E, and Buss E (2019) Ecological cocktail party listening 

reveals the utility of extended high-frequency hearing. Hearing Research, 381, 107773. PMID: 

31404807 

b. Vitela, A. D., Monson BB, and Lotto AJ (2015) Phoneme categorization relying solely on highfrequency energy. Journal of the Acoustical Society of America, 137(1), EL65-EL70. PMCID: 

PMC4272376 

c. Monson BB, Hunter EJ, and Story BH (2012) Horizontal directivity of low- and high-frequency 

energy in speech and singing. Journal of the Acoustical Society of America, 132(1), 433-441. 

PMCID: PMC3407162 

d. Monson BB, Lotto AJ, and Ternström S (2011) Detection of high-frequency energy changes in 

sustained vowels produced by singers. Journal of the Acoustical Society of America, 129(4), 2263-

2268. PMCID: PMC5570078 

4. A fundamental dilemma in neuroscience is explaining how biological sensory systems that cannot measure 

the properties that define the physical world nonetheless guide behaviors that are routinely successful. 

Rather than resorting to explanations in terms of the physical attributes of sensory stimuli, my collaborators 

and I drew upon principles of phylogenetic and ontogenetic experience with natural sensory stimuli to 

develop theoretical models that could explain otherwise puzzling phenomena in auditory and visual 

perception. 

a. Purves D, Monson BB, Sundararajan J, and Wojtach W (2014) How biological vision succeeds in 

the physical world. Proceedings of the National Academy of Sciences, 111(13), 4750-4755. PMCID: 

PMC3977276 

b. Morgenstern Y, Rukmini DV, Monson BB, and Purves D (2014) Properties of artificial neurons that 

report lightness based on accumulated experience with luminance. Frontiers in Computational 

Neuroscience. 8:134. PMCID: PMC4217489 

c. Monson BB, Han S, and Purves D (2013) Are auditory percepts determined by experience? PLOS 

One, 8(5): e63728. PMCID: PMC3646789 

5. My earliest work addressed the need to improve noise control for small cooling fans found in standard 

electronic devices (e.g., computers). While prior efforts had demonstrated the feasibility of utilizing active 

noise control methods for this application, implementing the technique was limited by space limitations 

imposed by industry standards and trends toward smaller devices. My research demonstrated one possible 

solution for this problem by using a smaller cooling fan (running at higher speeds) with active noise control 

electronics imbedded. With this approach, we achieved reduced noise levels comparable to those achieved 

for larger, quieter fans. 

a. Monson BB, Sommerfeldt SD, and Gee KL (2007) Improving compactness for active noise control 

of a small axial cooling fan. Noise Control Engineering Journal 55 (4), 397-407. 

b. Monson BB, Sommerfeldt SD (2004) Global active control of tonal noise from small axial cooling 

fans. INTER-NOISE and NOISE-CON Congress and Conference Proceedings 9, 327-337. 

Complete List of Published Work in MyBibliography: 

http://www.ncbi.nlm.nih.gov/sites/myncbi/brian.monson.1/bibliography/48121627/public/?sort=date&direction=a 

scending 

D. Research Support

Ongoing support 

Center for Health, Aging and Disability Pilot Grant Brian Monson (PI) 07/01/18-12/31/19 

Biosketches Page 19 
 

 

 

Contact PD/PI: Monson, Brian Bruce 

University of Illinois at Urbana-Champaign 

Title: Capturing perinatal auditory experience 

The goal of this study is to investigate the differences between intrauterine auditory exposures for fetuses and 

NICU auditory exposures for preterm infants. 

Role: PI 

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OMB No. 0925 0001 and 0925 0002 (Rev. 09/17 Approved Through 03/31/2020) 

BIOGRAPHICAL SKETCH 

Prov de the fo ow ng nformat on for the Sen or/key personne and other s gn f cant contr butors. 

Fo ow th s format for each person. DO NOT EXCEED FIVE PAGES. 

NAME: Derrick Rollo 

eRA COMMONS USER NAME (credential, e.g., agency login): 

POSITION TITLE: Physician, Neonatology 

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, 

include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) 

INSTITUTION AND LOCATION 

DEGREE 

(if 

applicable) 

Completion 

Date 

MM/YYYY 

FIELD OF STUDY 

Wartburg College, Waverly, IA 

Des Moines University, Des Moines, IA 

University of Illinois College of Medicine, Peoria, IL 

University of Illinois College of Medicine, Peoria, IL 

University of Louisville Kosair Children's Hospital, 

Louisville, KY 

B.A. 

D.O. 

Residency 

Residency 

Fellowship 

2002 

2006 

2007 

2009 

2012 

Biology 

General Medicine 

Internal Medicine 

Pediatrics 

Neonatology 

A. Personal Statement 

I have been a practicing pediatric physician for 13 years with a specialty in Neonatology for 10. I have 

specific interests in neonatal research, neonatal environmental exposures, neonatal nutrition, and 

extrauterine growth restriction. I will be directly involved with the proposed research by actively recruiting 

patients, reviewing charts, and making recommendations to Dr. Monson from a clinical practice perspective 

in regards to the study. 

B. Positions and Honors 

2015-Present Associate Medical Director of Newborn Services, Perinatal Program, Carle Foundation 

Hospital 

2015-Present Co-Director of Level III Perinatal Program, Carle Foundation Hospital 

2014-Present Attending Neonatologist, Carle Foundation Hospital 

2014-Present Clinical Assistant Professor, University of Illinois, Urbana-Champaign, IL 

2012-2014 Attending Neonatologist, Indiana University 

2012-2014 Clinical Instructor, Indiana University, Bloomington, IN 

2010 NRP Instructor, Project Vietnam, Saigon, Tuy Hoa, Hanoi 

2009-2012 Clinical Instructor, University of Louisville, Louisville, KY 

2009-2012 Primary Investigator, University of Louisville, Louisville, KY 

2008 Camp Counselor, American Diabetes Association, Camp Granada, Illinois 

2007-2009 Program Delegate, American Academy of Pediatrics, Illinois 

2006-2009 NRP Instructor, University of Illinois, Peoria, Illinois 

2003-2004 Teaching Assistant-Physical Diagnosis, Des Moines University, Des Moines, Iowa 

2003-2004 Teaching Assistant-Osteopathic Manipulative Medicine, Des Moines University, Des Moines, 

Iowa 

2003 Research Assistant, Iowa State University, Ames, Iowa 

2001 Research Assistant, Colorado State University, Fort Collins, Colorado 

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Boards/Membership

American Board of Pediatrics 

American Board of Pediatrics, Neonatal-Perinatal Medicine 

National Board of Osteopathic Medical Examiners 

American Academy of Pediatrics 

American Medical Association 

Honors/Awards

2011 Fellow Research Award 

C. Contributions to Science 

1. Blue light phototherapy is the standard of care for neonatal hyperbilirubinemia (jaundice). Although 

quantitative measurements of blue light exposure are important, current measurement systems have 

limited applicability outside of laboratories because of an unfavorable set of factors in bulk, weight, cost, 

and accuracy. In this study, we used optical metrology approaches, optoelectronic designs, and 

wireless modes of operation to serve as the basis for miniature, low-cost, and battery-free devices for 

precise dosimetry. Evaluations on human participants captured instantaneous and cumulative exposure 

for neonates during blue light phototherapy in our neonatal intensive care unit at Carle Foundation 

Hospital. We also monitored solar UV exposure for adults during outdoor activities, and tracked light 

illumination for seasonal affective disorder phototherapy. Versatile applications of this dosimetry 

platform provide means for consumers and medical providers to modulate light exposure across the 

electromagnetic spectrum in a way that can both reduce risks in the context of excessive exposure and 

optimize benefits in the context of phototherapy. 

a. Heo SY, Kim J, Gutruf P, Banks A, Wei P, Pielak R, Balooch G, Shi Y, Araki H, Rollo D, Gaede C, 

Patel M, Kwak JW, Peña-Alcántara AE, Lee KT, Yun Y, Robinson JK, Xu S, Rogers JA (2018) 

Wireless, battery-free, flexible, miniaturized dosimeters monitor exposure to solar radiation and to 

light for phototherapy. Science Trans Med 10 (470):eaau1643. PMCID: PMC6361379 

2. Lactoferrin from human milk provides antimicrobial and anti-inflammatory action in the neonatal 

intestine. Human milk-fed, critically ill neonates often receive previously frozen milk. Freezing is known 

to have deleterious effects on proteins. The aim of this study was to determine the effect of low 

temperature storage of human milk on the concentration of lactoferrin. Milk samples were collected and 

stored for different periods of time and at different temperatures per Centers for Disease Control and 

Prevention recommendations. Lactoferrin concentrations following freezing were compared with that in 

fresh human milk. Lactoferrin concentrations in refrigerated milk samples were stable for 5 days. After 3 

months at -18 to -20 C, the average decrease was 37%. Following storage for 6 months at -20 °C, 

lactoferrin decreased to 46%. Five-day refrigeration of human milk does not appreciably decrease 

lactoferrin levels. Freezing milk for 3 months or more significantly lowers lactoferrin levels. There may 

be a role for occasionally providing fresh milk to critically ill neonates. 

a. Rollo DE, Radmacher PG, Turcu RM, Myers SR, Adamkin DH (2014) Stability of lactoferrin in 

stored human milk. J Perinatology 34(4):284-286. PMID: 24503914 

D. Additional Information: Research Support and/or Scholastic Performance 

Ongoing 

Center for Health, Aging and Disability Pilot Grant Brian Monson (PI) 07/01/18-12/31/19 

University of Illinois at Urbana-Champaign 

Title: Capturing perinatal auditory experience 

The goal of this study is to investigate the differences between intrauterine auditory exposures for fetuses and 

NICU auditory exposures for preterm infants. 

Role: Co-Investigator 

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OMB No. 0925 0001 and 0925 0002 (Rev. 09/17 Approved Through 03/31/2020) 

BIOGRAPHICAL SKETCH 

Prov de the fo ow ng nformat on for the Sen or/key personne and other s gn f cant contr butors. 

Fo ow th s format for each person. DO NOT EXCEED FIVE PAGES. 

NAME: Carolyn J. Brown 

eRA COMMONS USER NAME (credential, e.g., agency login): 

POSITION TITLE: Professor 

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, 

include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) 

INSTITUTION AND LOCATION 

DEGREE 

(if applicable) 

Completion 

Date 

MM/YYYY 

FIELD OF STUDY 

University of Iowa, Iowa City, IA 

University of Washington, Seattle, WA 

University of Iowa, Iowa City, IA 

B.S. 

M.S. 

Ph.D. 

05/1980 

12/1982 

05/1989 

Speech & Hearing 

Science 

Audiology 

Hearing Science 

A. Personal Statement 

I am a professor at the University of Iowa with joint appointments in the Department of Communication 

Sciences and Disorders and Otolaryngology. My research explores the intersection between cochlear implants 

and auditory physiology. Much of our current work is designed to assess the role of the auditory periphery in 

determining outcome with a cochlear implant and how “objective” or non-behavioral measures of auditory 

function, evoked using either acoustic or electrical stimulation can be used to inform clinical decision making. I 

have an active lab, a history of NIH funding and have mentored the research efforts of a number of young 

investigators. I have experience working in both medical and academic environments. I have worked as a 

clinical audiologist and I teach the auditory evoked potential coursework in the CSD program at the University 

of Iowa and recently helped establish a pediatric auditory evoked response training clinic in our department. All 

of these experiences will, no doubt, prove helpful in my role as consultant for Brian Monson on this novel and 

interesting proposal. Although I have not had experience with the LENA system, I am very happy to help him 

refine the auditory brainstem response methods and troubleshoot as needed during the period covered by this 

grant. 

B. Positions and Honors 

Employment History 

1989-1991 Assistant Professor, Dept. Speech and Hearing Science Arizona State University, Tempe, AZ 

1991-1996 Assistant Research Scientist, Dept. Otolaryngology - HNS, University of Iowa, Iowa City, IA 

1996-1997 Associate Research Scientist, Dept. Otolaryngology – HNS, University of Iowa, Iowa City, IA 

1997-2006 Associate Professor, Dept. Communication Sci & Disorders, University of Iowa, Iowa City, IA & 

Dept. Otolaryngology – HNS, University of Iowa, Iowa City, IA 

2006- Professor, Dept. Communication Sciences & Disorders, University of Iowa, Iowa City, IA and 

Dept. Otolaryngology – HNS, University of Iowa, Iowa City, IA 

Professional Memberships 

American Speech Language and Hearing Association (CCC-A): member since 1981 

Iowa Speech Language and Hearing Association: member since 1985 

American Auditory Society (AAS): member since 1996 

American Cochlear Implant Alliance (ACI Alliance): member since 2013 

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Editorial Boards, Manuscript and Grant Review Panels 

1998 - 1999 Associate editor: Ear and Hearing (1998-1999) 

2008 Invited guest editor: Ear and Hearing (2008) 

2008 - 2010 Associate editor: Volta Review (2008-2010) 

2009 - 2011 Associate editor: American Journal of Audiology (2009-2011) 

2011- 2013 Member: Publication Board, American Speech Lang Hearing Assoc (2011-2013). 

2014 Ad Hoc member: special study section to review F31 and F32 applications for NIH/NIDCD 

2014 Ad Hoc member: sensorimotor integration study section to review R15 applications for NIH 

2015 Ad Hoc member: Auditory Study Section to review R01 applications for NIH/NIDCD 

2018 Ad Hoc member: P50 Review panel, ZDC1SRB-K 

Honors 

1999 Best Research Presentation Award, Custom Sound Outcomes Seminar, Sintra, Portugal 

1999-2000 Research Advisor, Best Student Research Paper from American Academy of Audiology 

2000 Annual Editor’s Award for outstanding research article in Ear and Hearing 

2009-2011 Invited Member, CLAS Promotion and Tenure Committee, University of Iowa 

2011 Marion L. Huit Distinguished Teaching Award, University of Iowa 

2015 Keynote Speaker: International Evoked Response Audiometry Study Group, Busan, Korea 

2017 Invited Speaker: Conference on Implantable Auditory Prostheses. Lake Tahoe, California 

2018 Invited Speaker: Objective Measures in Auditory Implants. Tel Aviv, Israel 

C. Contributions to Science 

My NCBI Bibliography can be found at the following website: 

http://www.ncbi.nlm.nih.gov/sites/myncbi/camille.dunn.1/bibliography/49443426/public/?sort=date&direction=as 

cending 

Electrically Evoked Auditory Potentials: Early Studies 

My early work focused on describing and refining objective, or more precisely non-behavioral, methods for 

assessing hearing in cochlear implant users. Paul Abbas and I were one of the first groups to report methods 

for recording the electrically evoked auditory brainstem response (EABR) but we are, perhaps, best known for 

a series of papers that grew out of my dissertation and outlined a method for recording compound action 

potentials from CI users (ECAPs). At the time we published those studies, CI technology was new and 

outcomes were variable. Many candidates for a CI were either long deafened or had lost their hearing years 

ago due to meningitis. This electrically evoked response provided much needed way to assess neural integrity 

and led to the development of neural telemetry systems available on all commercial CI systems on the market 

today. Examples of some of these foundational studies include: 

Brown, C. J., Abbas, P. J., Gantz, B. (1990). Electrically evoked whole-nerve action potentials: data from 

human cochlear implant users. The Journal of the Acoustical Society of America, 88(3), 1385-91. 

Brown, C. J., Abbas, P. J., Borland, J., Bertschy, M. R. (1996). Electrically evoked whole nerve action 

potentials in Ineraid cochlear implant users: responses to different stimulating electrode configurations 

and comparison to psychophysical responses. Journal of Speech and Hearing Research, 39(3), 453-

67. 

Brown, C. J., Abbas, P. J., Borland, J., Bertschy, M. R. (1996). Electrically evoked whole nerve action 

potentials in Ineraid cochlear implant users: responses to different stimulating electrode configurations 

and comparison to psychophysical responses. Journal of Speech and Hearing Research, 39(3), 453-

67. 

Miller, C. A., Abbas, P. J., Brown, C. J. (2000). An improved method of reducing stimulus artifact in the 

electrically evoked whole-nerve potential. Ear and Hearing, 21(4), 280-90 

Electrically Evoked Compound Action Potentials (ECAP) in Research and in Clinical Practice 

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ECAPs moved quickly from the lab into the clinic once Cochlear Corporation introduced the Nucleus CI24M 

device. The primary clinical application for these measures was – and continues to be – as a method for 

programming the speech processor of the CI. Numerous studies were published that described methods for 

achieving this goal. Ours were among the first and even today are widely referenced. Beyond predicting MAP 

levels, this neural response also can be used to track changes in hearing over time, measure current spread 

and/or channel interaction at the level of the cochlea and characterize the response of the auditory periphery to 

electrical stimulation. Examples of these studies are listed below. In each case, I played a lead role in all 

phases of the study including design, data collection and analysis of the outcome. 

Hughes, M. L., Brown, C. J., Abbas, P. J., Wolaver, A. A., Gervais, J. P. (2000). Comparison of EAP 

thresholds with MAP levels in the Nucleus 24 cochlear implant: Data from children. Ear and Hearing, 

21(2), 164-74. 

Brown, C. J., Hughes, M. L., Luk, B., Abbas, P. J., Wolaver, A., Gervais, J. (2000). The relationship 

between EAP and EABR thresholds and levels used to program the Nucleus 24 speech processor: 

Data from adults. Ear and Hearing, 21(2), 151-63. 

Abbas, P. J., Hughes, M. L., Brown, C. J., Miller, C. A., South, H. (2004). Channel interaction in cochlear 

implant users evaluated using the electrically evoked compound action potential. Audiology & 

Neurotology, 9(4), 203-13. 

Miller, C. A., Brown, C. J., Abbas, P. J., Chi, S. L. (2008). The clinical application of potentials evoked from 

the peripheral auditory system. Hearing Research, 242(1-2), 184-97. 

Hybrid Cochlear Implant Studies 

The studies below focus on results obtained from CI users with residual acoustic hearing in the implanted ear. 

This is a unique population and our work describes a novel method of assessing cochlear health. 

Abbas, P. J., Tejani, V. D., Scheperle, R. A., Brown, C. J. (2017) Using Neural Response Telemetry to 

Monitor Physiological Responses to Acoustic Stimulation in Hybrid Cochlear Implant Users. Ear 

and Hearing.38, 409-425. PMID: 28085738. 

Shearer AE, Eppsteiner, RW, Frees K, Tejani V, Sloan-Heggen CM, Brown C, Abbas P, Dunn C, Hansen 

MR, Gantz BJ, Smith RJH. (2017). Genetic variants in the peripheral auditory system significantly 

affect adult cochlear implant performance. Hear Res. 348, 138-142. PMID: 28213135 

Kim JR, Tejani VD, Abbas PJ, Brown CJ. (2017). Intracochlear Recordings of Acoustically and 

Electrically Evoked Potentials in Nucleus Hybrid L24 Cochlear Implant Users and their Relationship 

to Speech Perception. Front Neurosci. 19, 216, PMID 28469553. 

Scheperle, R. A., Tejani, V., Omtvedt, J., Brown, C. J., Abbas, P. J., Hansen, M. R., Gantz, B. J., Oleson, 

J., Ozanne, M. (2017) Delayed Changes in Auditory Status in Cochlear Implant Users with 

Preserved Acoustic Hearing. Hear Res, 350, 45-57. 

D. Additional Information: Research Support and/or Scholastic Performance 

Ongoing: 

NIH/NIDCD: 

Funded: 

P50 DC000242 

2018-2021 

Bruce Gantz (PI) 

Title: Iowa Cochlear Implant Project VII 

Role: PI Project 2: Peripheral Electrophysiology Section 

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The studies included during this funding period focus on acoustic and electrically evoked responses that we 

use to characterize processing of sound at the auditory periphery. Our focus is on CI users with residual 

acoustic hearing in their implanted ear. 

Completed:

NIH/NIDCD: 

Funded: 

P50 DC000242 

2011-2017 

Bruce Gantz (PI) 

Title: Iowa Cochlear Implant Project VI 

Role: Co-PI Project 4: Electrophysiology Section 

The studies included during this funding period focus on further exploration of clinical applications for 

electrically evoked auditory potentials in cochlear implant recipients. In this proposal the focus is on Hybrid CI 

users and on developing a protocol for moving this evoked potential tool into clinical practice. 

NIH/NIDCD: R01 DC012082 Carolyn Brown (PI) 

Funded: 2012 - 2015, no-cost extension granted until 8/31/16 

Title: Evoked Potentials & Music Perception: Effects of Hearing Loss and Training 

Role: PI (with Kate Gfeller, Co-PI) 

In this study we use cortical evoked potentials to assess how hearing-impaired listeners perceive music, 

whether or not they benefit from focused training, and whether the gains they receive from such training 

generalize to perception of speech in noise. 

NIH/NIDCD: F31 DC012961 Benjamin Kirby (PI) 

Funded: 2012-2014 

Title: The Impact of Frequency Compression on Cortical Evoked Potentials and Perception 

Role: Primary Sponsor 

The focus of this proposal is to examine the extent to which cortical evoked potentials might be used as an 

objective index of the benefits of frequency compression technology on perception. 

NIH/NIDCD: RC1 DC010696 Carolyn Brown (PI) 

Funded 2009-2012 

Title: Optimizing Acoustic and Electric Hearing for Hybrid CI Users 

Role: PI (Christopher Turner, Co-PI) 

The goal of this study was to determine how best to divide the acoustic spectrum between the hearing aid and 

the processor of the cochlear implant for Hybrid CI users. Within-subject comparisons between results 

obtained using evoked potential and behavioral techniques were compared. 

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OMB No. 0925 0001 and 0925 0002 (Rev. 09/17 Approved Through 03/31/2020) 

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NAME: Ambrose, Sophie E. 

eRA COMMONS USER NAME (agency login): 

POSITION TITLE: Coordinator of the Clinical Measurement Program 

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, 

include postdoctoral training and residency training if applicable.) 

INSTITUTION AND LOCATION 

DEGREE 

(if applicable) 

Completion Date 

MM/YYYY FIELD OF STUDY 

University of Central Arkansas 

University of Kansas 

University of Kansas 

Father Flanagan's Boys' Home d/b/a 

Boys Town Nat'l Research Hospital 

B.S. 

M.A. 

Ph.D. 

Postdoc Fellow 

08/2002 

08/2006 

12/2009 

02/2013 

Speech Language Pathology 

Speech Language Pathology 

Speech Language Pathology 

Communication Disorders 

A. Personal Statement 

I will serve as a consultant on the proposed project, which I think has strong potential to produce findings 

that help us understand the extent to which the speech, language, and auditory deficits evidenced by infants 

who spent time in the NICU are a result of experiencing abnormal perinatal auditory input. I will consult with the 

PI on scientific issues pertaining to the LENA (Language Environment Analysis) recordings and measuring infant 

vocal development. As one of the earliest adopters of LENA technology, I was able to build collaborations with 

the LENA Foundation staff, which has allowed me to develop unique expertise pertaining to use of the LENA 

and has led to presentations and publications on our shared work. Additionally, I have used the technology to 

pursue my own line of research, which has focused on understanding how the environments of children with 

hearing loss contribute to variance in their speech, language, and literacy outcomes. Another line of my research 

has focused on measuring the vocal development of infants and toddlers. This work has included being a codeveloper of the Vocal Development Landmarks Interview, a parent-interview tool utilized to measure the vocal 

development of 6- to 21-month-old infants. Both lines of work have resulted in several publications. 

1. Ambrose, S. E., Walker, E., Unflat-Berry, L., Oleson, J., & Moeller, M. P. (2015). Quantity and quality of 

caregivers’ linguistic input to 18-month and 3-year old children who are hard of hearing. Ear and Hearing, 

36(Suppl. 1), 48–59. [PMCID: PMC4703365] 

2. VanDam, M., Oller, D. K., Ambrose, S. E., Gray, S., Richards, J. A., Xu, D., . . . Moeller, M. P. (2015). 

Automated vocal analysis of children with hearing loss and their typical and atypical peers. Ear and 

Hearing, 36(4), 146-152. [PMCID: PMC4478108] 

3. Ambrose, S. E., Thomas, A., & Moeller, M. P. (2016). Assessing vocal development in infants and 

toddlers who are hard of hearing: A parent-report tool. Journal of Deaf Studies and Deaf Education, 21(3), 

237-248. [PMCID: PMC4902879] 

4. Moeller, M. P., Thomas, A. E., Oleson, J., & Ambrose, S. E. (2019). Validation of a parent report tool for 

monitoring early vocal stages in infants. Journal of Speech, Language, and Hearing Research, 62(7), 

2245-2257. [PMCID: PMC31265353] 

B. Positions and Honors 

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Positions and Employment 

2004-2006 Research Assistant, Language Intervention Laboratory, University of Kansas Medical Center, 

Kansas City, KS 

2006-2010 Research Associate and Speech Language Pathologist, Children's Auditory Research and 

Evaluation Center, House Ear Institute, Los Angeles, CA 

2010-2013 Postdoctoral Fellow, Center for Childhood Deafness, Father Flanagan's Boys' Home doing 

business as Boys Town National Research Hospital, Omaha, NE 

2013-2019 Staff Scientist and Director of the Communication Development Lab, Center for Childhood 

Deafness, Language, and Learning, Father Flanagan’s Boys’ Home doing business as Boys 

Town National Research Hospital, Omaha, NE 

2018- Coordinator of the Clinical Measurement Program, Center for Childhood Deafness, Language, 

and Learning, Father Flanagan’s Boys’ Home doing business as Boys Town National Research 

Hospital, Omaha, NE 

Other Experience and Professional Memberships 

Multiple Ad hoc reviewer: American Journal of Speech-Language Pathology; Ear and Hearing; Folia 

Phoniatrica et Logopaedica; International Journal of Audiology; Journal of Child Language; 

Journal of Educational Audiology; Journal of Speech, Language, and Hearing Research; 

Language Learning and Development; Language, Speech, and Hearing Services in Schools; 

Perspectives on Hearing and Hearing Disorders in Children; The Volta Review 

2006- Member, American Speech-Language-Hearing Association 

2007- Certificate of Clinical Competence in Speech-Language-Pathology, American SpeechLanguage-Hearing Association 

2010- License to practice speech-language pathology, State of Nebraska 

2011- Member, International Society for Gesture Studies 

2011-2017 Convention Planning Committee, American Speech-Speech-Language-Hearing Association 

2012-2013 Board member, Hand and Voices 

2014-2017 Professional Development Committee, ASHA Special Interest Group 9 - Hearing and Hearing 

Disorders in Childhood 

It Takes Two to Talk certification, Hanen Centre 2016 

2017- Hands & Voices Family Leadership in Language and Learning Scientific Language and Literacy 

Advisory Board 

Honors 

2002 Lila and Madison Self Graduate Fellow for Master's and Doctoral Studies, University of Kansas 

2008 Convention Recognition, American Speech-Language-Hearing Association 

2008 New Century Doctoral Scholarship, American Speech-Language-Hearing Association 

Foundation 

2009 Cochlear Implant Trainee Scholarship, 12th Symposium on Cochlear Implants in Children 

2010 Lessons for Success: Emerging Scientists Conference, American Speech-Language-Hearing 

Association 

2011 Clinical Practice Research Institute, American Speech-Language-Hearing Association 

2011 Research Mentoring Pair Travel Award, American Speech-Language-Hearing Association 

2011 Meritorious Poster, American Speech-Language-Hearing Association Convention 

2011 Student Travel Award, Symposium on Research in Child Language Disorders 

2012 Student Travel Award, Symposium on Research in Child Language Disorders 

2015 Co-recipient of the 2015 Ear and Hearing Editors’ Special Recognition for Outcomes of Children 

with Hearing Loss Special Issue 

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C. Contribution to Science 

1. Characterizing the language and literacy outcomes of children with hearing loss. Over the past 15 

years, the landscape for children with hearing loss has changed dramatically as a result of universal newborn 

hearing screenings and advances in assistive listening technologies, including cochlear implants. To determine 

the needs of this new generation of children with hearing loss, it has been necessary to conduct research on 

their language and literacy outcomes. My dissertation work and my early collaborations with Dr. Jean DesJardin, 

a collaborator at the House Ear Institute, focused on the literacy skills of preschool and school-age children with 

cochlear implants. This work established that although the majority of children with cochlear implants were able 

to establish age-appropriate print knowledge and word reading, they lagged behind their hearing peers in the 

development of phonological awareness. I continued this line of research as a member of the OCHL investigative 

team, where our findings indicated that speech production and morphosyntax are particularly vulnerable to the 

effects of hearing loss. This also fits with the findings I recently published from my R03, which indicate that the 

gestural abilities of toddlers with hearing loss are intact, but their spoken language skills are delayed in 

comparison to children with normal hearing. The common theme in the findings of these bodies of research are 

that children with hearing loss struggle with aspects of language development that are highly dependent upon 

access to the phonetic details of the speech signal. This work has led to calls for careful monitoring of skill 

development in areas that may be most impacted by limited auditory access. However, few measures exist that 

assess skills impacted by auditory access during infancy, thus I recently collaborated with colleagues to develop 

an innovative new measure of the vocal development of infants and toddlers with hearing loss – the Vocal 

Development Landmarks Interview. 

a. DesJardin, J. L., Ambrose, S. E., & Eisenberg, L. S. (2009). Literacy skills in children with cochlear 

implants: The importance of early oral language and joint storybook reading. Journal of Deaf Studies 

and Deaf Education, 14, 22-43. [PMCID: PMC2605187] 

b. Ambrose, S. E., Fey, M. E., & Eisenberg, L. S. (2012). Phonological awareness and print knowledge 

of preschool children with cochlear implants. Journal of Speech, Language, and Hearing Research, 55, 

811-823. [PMCID: PMC3370130] 

c. Tomblin, J. B., Harrison, M., Ambrose, S. E., Oleson, J., & Moeller, M. P. (2015). Language outcomes 

in young children with mild to severe hearing loss. Ear and Hearing, 36(Suppl. 1), 76–91. [PMCID: 

PMC4704115] 

d. Moeller, M. P., Thomas, A. E., Oleson, J., & Ambrose, S. E. (2019). Validation of a parent report tool 

for monitoring early vocal stages in infants. Journal of Speech, Language, and Hearing Research, 62(7), 

2245-2257. [PMCID: PMC31265353] 

2. Characterizing caregivers’ input and the auditory environments of children with hearing loss 

through use of LENA technology and behavioral observations. Extensive research has characterized 

caregiver input within caregiver-child interactions in which the child has normal hearing. Additionally, this line of 

research has identified the contributions of caregiver input to shaping children’s linguistic, academic, and 

cognitive outcomes. However, the vast majority of research on caregiver-child interactions in which the child has 

hearing loss was conducted prior to the implementation of universal newborn hearing screenings and recent 

advances in hearing assistive technologies. Thus, I have sought to characterize the quantity and quality of 

linguistic input caregivers provide to the current generation of children with hearing loss and how this is influenced 

by the children’s auditory environments. In my collaborations with Dr. Jean DesJardin, we identified aspects of 

the home literacy environment and higher-level facilitative language techniques utilized by mothers during book 

reading that are predictive of later language outcomes for children with cochlear implants. In work with the OCHL 

team utilizing Language Environment Analysis (LENA) technology, my research found that, in comparison to 

caregivers of children with normal hearing, caregivers of children with hearing loss engaged their children in 

fewer conversational turns. Conversational turns were decreased in households with high rates of electronic 

media exposure, pointing toward the importance of children’s auditory environments. In other work with the 

OCHL team, I found that caregivers of children with hearing loss utilized more directive language than caregivers 

of children with normal hearing. Additionally, in a recent study conducted in my lab, I found that mothers of 

toddlers with hearing loss are less responsive to their children’s gestures than are mothers of toddlers with 

normal hearing. This work has informed our understanding of how hearing loss can alter caregiver-child 

interactions, typically in ways that decrease features of input that are known to be facilitative of language 

development. 

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a. DesJardin, J. L., Ambrose, S. E., & Eisenberg, L. S. (2011). Maternal involvement in the home literacy 

environment: Supporting literacy skills in children with cochlear implants. Communication Disorders 

Quarterly, 32, 135-150. [Public Access Compliance – N/A, not NIH-funded research] 

b. VanDam, M., Ambrose, S.E., & Moeller, M. P. (2012). Quantity of parental language in the home 

environments of hard-of-hearing 2-year-olds. Journal of Deaf Studies and Deaf Education, 17, 402-420. 

[PMCID: PMC3529623] 

c. Ambrose, S. E., Vandam, M., & Moeller, M. P. (2014). Linguistic input, electronic media, and 

communication outcomes of toddlers with hearing loss. Ear and Hearing, 35, 139-47. [PMCID: 

PMC3944057] 

d. Ambrose, S. E. (2016). Gesture use in 14-month-old toddlers with hearing loss and their mothers’ 

responses. American Journal of Speech-Language-Pathology 25(4), 519-531. [PMID: PMC5373693] 

3. Contributors to variance in speech, language, and literacy outcomes of children with hearing loss.

One of the hallmarks of communication development for children with hearing loss is the high rates of variability 

in communication outcomes, with some children struggling to develop speech, language, and literacy skills while 

others develop communication skills on par with those of their hearing peers. My research program has sought 

to identify sources of variability in children’s outcomes. My early work with Dr. Eisenberg, as well as my 

dissertation work, focused on the contributions of speech perception abilities to language and literacy outcomes. 

More recently, as a part of the OCHL team, I have explored the contributions of auditory variables to speech and 

language development, including age at hearing aid fit, degree of hearing loss, audibility, and the benefits 

provided by hearing aids. I am continuing this work as a co-investigator on the school-age extension of this study 

(Outcomes of School-Age Children who are Hard of Hearing). The key findings from this work indicate that to 

promote strong language outcomes for children who are hard of hearing, access to linguistic input via hearing 

aids must be optimized. Additionally, in the OCHL study, collaborations with Dr. DesJardin, and work in my own 

laboratory, I have explored the contributions of caregivers’ linguistic input to the outcomes of children with hearing 

loss, identifying specific linguistic behaviors that support children’s language development. These findings have 

informed our understanding of how consistent hearing aid use and high-quality linguistic input can moderate the 

risk presented by hearing loss to language development. 

a. Tomblin, J. B., Oleson, J. J., Ambrose, S. E., Walker, E., & Moeller, M. P. (2014). The influence of 

hearing aids on the speech and language development of children with hearing loss. JAMA 

Otolaryngology – Head & Neck Surgery, 140, 403-409. [PMCID: PMC4066968] 

b. Walker, E., Ambrose, S. E., Oleson, J., & Moeller, M.P. (2017). False belief development in children 

who are hard of hearing compared to peers with normal hearing. Journal of Speech, Language, Hearing 

Research, 60(12), 3487-3506. [PMCID: PMC5962924] 

c. Ambrose, S. E., Unflat-Berry, L., Walker, E. A., Harrison, M., Oleson, J. J. & Moeller, M. P. (2014). 

Speech sound production in 2-year-olds who are hard of hearing. American Journal of SpeechLanguage Pathology, 23, 91-104. [PMCID: PMC4035418] 

d. Tomblin, J. B., Oleson, J. J., Ambrose, S. E., Walker, E., & Moeller, M. P. (2018). Early literacy 

predictors and second-grade outcomes in children who are hard of hearing. Child Development. doi: 

10.1111/cdev.13158 . [PMCID: PMC6456443, available 2020-04-09] 

Complete List of Published Work in MyBibliography:

http://www.ncbi.nlm.nih.gov/sites/myncbi/sophie.ambrose.1/bibliography/41280872/public/?sort

=date&direction=descending 

D. Research Support 

Ongoing Research Support 

None 

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Completed Research Support 

5 P20 GM109023-04 Leibold (PD) 05/15/14-03/31/19 

NIH-NIGMS 

Center for Perception and Communication in Children (CPCC) - The goal of the CPCC, a COBRE at the 

Boys Town National Research Hospital in Omaha, Nebraska, is to expand the range of the current research 

program by providing a unique environment for the development of junior faculty who have an interest in 

understanding the consequences of childhood hearing loss for speech and language perception and processing, 

and ultimately describing performance of children with hearing loss in the real world. 

Project 6: Efficacy of an Early Intervention Addressing Needs of Children with Hearing Loss. The longterm objective of this program of research is to develop evidence-based intervention techniques that can be utilized 

by practitioners to reduce the risk presented by hearing loss to children’s language development. 

Role: Lead Investigator, Project 6 (Project terminated on 8/1/2018) 

5 R01 DC009560-10 Tomblin & Moeller (MPI) 08/01/13-07/31/19 (no-cost ext.) 

NIH-NIDCD 

Outcomes of School-Age Children Who are Hard of Hearing 

This project seeks to obtain critical information regarding the language and academic outcomes of a large group 

of children with mild to severe hearing loss in the school years. 

Role: Co-Investigator 

5 R03 DC012647-03 Ambrose (PI) 03/04/13-02/28/17 (no-cost ext.) 

NIH-NIDCD 

Contributions of Gesture to the Linguistic Outcomes of Children with Hearing Loss 

The overarching goal of this research program is to elucidate the relationships between gesture and spoken 

language for children with hearing loss. 

Role: Principal Investigator 

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Fo ow th s format for each person. DO NOT EXCEED FIVE PAGES. 

NAME: Brittney Danielle-Baird Reidy 

eRA COMMONS USER NAME (credential, e.g., agency login): n/a 

POSITION TITLE: Clinical Assistant Professor 

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, 

include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) 

INSTITUTION AND LOCATION 

DEGREE 

(if 

applicable) 

Completion 

Date 

MM/YYYY 

FIELD OF STUDY 

Illinois State University, Normal, IL 

Illinois State University, Normal, IL 

AT Still University, Mesa, AZ 

B.S. 

M.S. 

AuD 

12/2001 

12/2005 

03/2012 

Speech 

Pathology/Audiology 

Audiology 

Audiology 

A. Personal Statement 

Over the course of my 14-year career, I’ve worked with patients of all ages performing a wide range of 

audiological assessments, including diagnostic testing, newborn hearing evaluations, electrophysiological 

testing, dispensing hearing aids and bone-anchored hearing aids, programming cochlear implants, and 

working with patients with special needs. My specialties include pediatrics, specifically conducting diagnostic 

auditory brainstem response evaluations on premature and term newborns and children. During my time at 

Southern Illinois University School of Medicine, I was involved in numerous clinical research projects, in which I 

conducted pre- and post-treatment clinical assessments for several hundred research subjects. Currently, I am 

a Clinical Assistant Professor and Audiology Clinic Coordinator at the University of Illinois at UrbanaChampaign. I have performed countless auditory brainstem response evaluations, analyses, and diagnoses on 

NICU babies, newborns, infants and toddlers, making me well suited to collect the audiological data for this 

proposal. My role in this study will be primarily to conduct and interpret pediatric audiological assessments, 

including otoscopy, immittance testing, distortion-product otoacoustic emissions, and diagnostic auditory 

brainstem responses. 

B. Positions and Honors 

Positions and Employment

2005 Audiologist, St. Joseph’s Institute for the Deaf, Chesterfield, MO 

2006 Chief Audiologist, Viers Hearing Center, Kirkwood, MO 

2006 Audiologist, Center for Hearing and Speech, St. Louis, MO 

2007-2017 Pediatric Audiologist, Southern Illinois University School of Medicine, Springfield, IL 

2018- Clinical Assistant Professor, Audiology Clinic Coordinator, Department of Speech and Hearing 

Science, University of Illinois at Urbana-Champaign, IL 

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C. Contributions to Science 

My contributions to science consist largely of collecting audiological data as a Sub Investigator on multiple 

clinical research projects. Because these were typically industry-sponsored projects assessing the efficacy and 

safety of different industry-developed drugs or treatments (see below), research products (abstracts, posters, 

and/or publications) and my role in research product development were limited. Most recently I have been 

collecting natural sleep auditory brainstem response data on 3-month-old infants for a sponsored project with 

Dr. Monson as PI. 

D. Additional Information: Research Support and/or Scholastic Performance 

Ongoing

Title: Capturing perinatal auditory experience 

Sponsor: Center for Health, Aging, and Disability; University of Illinois at Urbana-Champaign 

The goal of this study is to investigate the differences between intrauterine auditory exposures for fetuses and 

NICU auditory exposures for preterm infants. 

PI: Monson 

Role: Audiologist 

July 2018-present 

Completed (past three years) 

Title: A 6-Month, Multicenter, Phase 3, Open-Label Extension Safety Study Of OTO-104 given at 3-Month 

Intervals by Intratympanic Injection in Subjects with Unilateral Meniere’s Disease 

Sponsor: Otonomy, Inc 

Protocol: 104-201509 

The goal of this study was to assess whether multiple injections of an industry-developed drug had any 

negative impact on hearing, tinnitus, and/or vestibular function for patients with Meniere’s disease. 

PI: Bauer 

Role: Sub Investigator 

July 2016 – July 2017 

Title: A Prospective, Randomized, Double Blind, Placebo-Controlled, Multicenter, Phase 3 Efficacy and Safety 

Study of OTO-104 Given as a Single Intratympanic Injection in Subjects with Unilateral Meniere’s Disease 

Sponsor: Otonomy, Inc 

Protocol: 104-201506 

The goal of this study was to assess whether a single injection of an industry-developed drug led to 

improvements in hearing, tinnitus, and/or vestibular function for patients with Meniere’s disease. 

PI: Bauer 

Role: Sub Investigator 

May 2016 – May 2017 

Title: Safety and Efficacy of EXE844 Otic Suspension in the Treatment of Otitis Media at Time of 

Tympanostomy Tube Insertion 

Sponsor: Alcon 

Protocol: EXE844b-C002 

The goal of this study was to assess whether an industry-developed ear drop, administered simultaneous with 

tympanostomy, led to accelerated healing of otitis media for pediatric patients. 

PI: Ettema 

Role: Sub Investigator 

December 2015 – September 2016 

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Follow this format for each person. DO NOT EXCEED FIVE PAGES. 

NAME: Sa Shen, Ph.D. 

eRA COMMONS USER NAME (credential, e.g., agency login): 

POSITION TITLE: Director of Biostatistical Services/Associate Professor 

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, 

include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) 

INSTITUTION AND LOCATION 

DEGREE 

(if 

applicable) 

Completion 

Date 

MM/YYYY 

FIELD OF STUDY 

Sun Yat-sen University, P.R. of China 

Sun Yat-sen University, P.R. of China 

University of Pittsburgh, Pittsburgh, PA 

B.A. 

M.S. 

Ph.D. 

06/1989 

06/1992 

12/1997 

Mathematics 

Mathematics 

Statistics 

A. Personal Statement 

As a biostatistician, I have a strong background in academic training and research methodology in statistics, and 

extensive experience in the application of statistical models in public health research. My research contributions 

have covered a wide range of fields such as psychiatry, psychology, pediatrics, kinesiology and epidemiology. I 

am familiar with randomized controlled trials, longitudinal data analyses and statistical genetic analysis, given 

my previous work with several NIMH or NIH-funded grants. My research at Columbia University and the 

University of Pittsburgh focused on the application of highly sophisticated statistical approaches for various 

measurements with a pediatric population. I have conducted statistical analyses identifying psychological and 

biological antecedents of alcoholism in a longitudinal high-risk offspring design. At the University of Illinois at 

Urbana-Champaign, I advanced my research on the risk factors for community health problems in people of all 

ages. I have published many articles on longitudinal studies and randomized clinical trials in peer-reviewed 

journals. Taken in its entirety, my previous experience as a statistician and co-investigator has given me an 

extensive background in both design and analysis, which is necessary in my role as the co-investigator/senior 

biostatistician for the proposed study. With my expertise in these areas, I will work with principal investigator and 

other co-investigators in the study design, data analysis, and interpretation of the study findings. 

B. Positions and Honors 

2013 - present Associate Professor, Department of Kinesiology and Community Health, College of Applied 

Health Sciences, University of Illinois at Urbana-Champaign, IL 

2013 - present Director of Biostatistical Services, Center on Health, Aging, and Disability, College of 

Applied Health Sciences, University of Illinois at Urbana-Champaign, IL 

2013 - present Core Biostatistician, Interdisciplinary Health Sciences Institute, University of Illinois at 

Urbana-Champaign, IL 

2014 - 2015 Instructor, College of Medicine, University of Illinois at Urbana-Champaign, IL. 

Course taught: Medical Statistics. 

2014 - 2015 Instructor, Department of Kinesiology & Community Health, College of Applied Health 

Sciences, University of Illinois at Urbana-Champaign, IL. 

Course taught: Biostatistics in Public Health. 

2004 - 2013 Assistant Professor, Department of Psychiatry, Columbia University, New York, NY 

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2004 - 2013 Senior Biostatistician, Research Foundation for Mental Hygiene, New York, NY 

2004 - 2013 Senior Biostatistician, New York State Psychiatric Institute, New York, NY 

1997 - 2004 Senior Statistician, Department of Psychiatry/Western Psychiatric Institute and Clinic, 

University of Pittsburgh School of Medicine, Pittsburgh, PA 

C. Contributions to Science 

1. Longitudinal Data Analysis: I have been interested in analyzing longitudinal health data in adolescents and 

adults. Specifically, I have applied advanced statistical methods, including generalized estimating equation 

approaches and generalized linear mixed models, to health outcomes. This includes outcomes from 

multidisciplinary fields like psychiatry, psychology, pediatrics, and epidemiology and community health. 

a. Bird H.R., Shrout P.E., Duarte C.S., Shen S., Bauermeister J.J., and Canino G. (2008): Longitudinal 

Mental Health Service and Medication Use for ADHD among Puerto Rican Youth in Two Contexts. 

Journal of the American Academy of Child and Adolescent Psychiatry, 47(8): 879-889. 

b. Suglia S.F., Shen S., Cohall A., Bird H., Canino G., Brown J., and Duarte C.S. (2016): Use of Health 

Services by Maltreated Children in Two Different Sociocultural Contexts: Where Can Doors for 

Interventions Be Opened? Journal of Interpersonal Violence. 2016 Jul 31. 

c. Duarte, C., Eisenberg, R, Musa, G.J., Addolorato, A., Shen, S. and Hoven, C.W. (2017). Children’s 

Knowledge about Parental Exposure to Trauma. Journal of Child & Adolescent Trauma. 

10.1007/s40653-017-0159-7. 

d. Geronazzo-Alman L., Eisenberg R., Shen S., Duarte C.S., Musa G.J., Wicks J., Fan B., Doan T., 

Guffanti G., Bresnahan M., and Hoven C.W. (2017): Cumulative Exposure to work-related traumatic 

events and current post-traumatic stress disorder in New York City's first responders. Comprehensive 

Psychiatry, 74:134-143. 

e. An R., Nickols-Richardson S., Alston R., Shen S., and Clarke C. (2019). Fresh and Lean Beef 

Consumption in Relation to Nutrient Intakes and Diet Quality among U.S. Adults, 2005–2016. Nutrients, 

11(3), 563; doi: 10.3390/nu11030563. 

2. Randomized Controlled Trials: My interest in studying randomized controlled trials began when I worked on 

a multisite clinical trial with faculty from psychiatry. Since then, I have been collaborating with investigators 

from various institutes on multiple randomized trials, which are supported by the NIH and NIMH. We have 

applied the intent-to-treat principle to numerous randomized trials, and examined the effects of treatments 

and behavioral interventions on health outcomes over time. 

a. Brent D., Greenhill L.L, Compton S., Emslie G., Wells K., Walkup J.T., Vitiello B., Bukstein O., Stanley 

B., Posner K., Kennard B.D., Coffey B., Cwik M.F., Wagner A., March J.S., Riddle M., Goldstein T., 

Curry J., Barnett S., Capasso L., Zelazny J., Hughes J., Shen S., Gugga S.S., & Turner J.K., (2009). 

The Treatment of Adolescent Suicide Attempters (TASA): Predictors of suicidal events in an open 

treatment trial. Journal of the American Academy of Child and Adolescent Psychiatry, 48(10): 987-996. 

b. Vitiello B., Brent D., Greenhill L.L, Emslie G., Wells K., Walkup J.T., Stanley B., Bukstein O., Kennard 

B.D., Compton S., Coffey B., Cwik M.F., Posner K., Wagner A., March J.S., Riddle M., Goldstein T., 

Curry J., Capasso L., Mayes T., Shen S., Gugga S.S., Turner J.K., Barnett S., & Zelazny J. (2009). 

Depressive symptoms and clinical status during the Treatment of Adolescent Suicide Attempters 

(TASA) study. Journal of the American Academy of Child and Adolescent Psychiatry, 48(10): 997-

1004. 

c. Rynn M.A., Walkup J.T., Compton S.N., Sakolsky D.J., Sherrill J.T., Shen S., Kendall P.C., McCracken 

J., Albano A.M., Piacentini J., Riddle M.A., Keeton C., Waslick B., Chrisman A., Iyengar S., March J.S., 

and Birmaher B. (2015): Child/Adolescent Anxiety Multimodal Study: Evaluating Safety. Journal of the 

American Academy of Child and Adolescent Psychiatry, 54(3): 180-190. 

d. Sung J.H., Shen S., Motl R.W., and Sosnoff J.J. (2016): Bladder Function and Falls in Individuals with 

MS. Disability and Rehabilitation. 38(22): 2193-2197. 

e. Ehlers, D.K., Banducci, S.E., Daugherty, A.M., Fanning, J., Awick, E.A., Porter, G.C., Burzynska, A., 

Shen, S., Kramer, A.F., and McAuley, E. (2017). Effects of Gait Self-Efficacy and Lower-Extremity 

Biosketches Page 35 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Physical Function on Dual-Task Performance in Older Adults. BioMedical Research International. 

2017:8570960. doi:10.1155/2017/8570960. 

3. Psychometric Assessment: As a senior biostatistician on projects, I also provide collaboration on survey or 

instrument development and validation. 

a. Posner K., Brown G.K., Stanley B., Brent D.A., Yershova K.V., Oquendo M.A., Currier G.W., Melvin 

G.A., Greenhill L., Shen S., and Mann J.J. (2011): The Columbia-Suicide Severity Rating Scales: Initial 

Validity and Internal Consistency Findings From Three Multisite Studies With Adolescents and Adults. 

American Journal of Psychiatry, 168: 1266-1277. 

b. Matte B., Rohde L.A., Turner B., Fisher P.W., Shen S., and Bau C.H.D. (2015): Reliability and Validity 

of Proposed DSM-5 ADHD Symptoms in a Clinical Sample of Adults. The Journal of Neuropsychiatry 

and Clinical Neurosciences, 27(3): 228-236. 

c. Sung J., Ousley C.M., Shen S., Isaacs Z.J., Sosnoff J.J., and Rice L.A. (2016): Reliability and validity of 

the function in sitting test in nonambulatory individuals with multiple sclerosis. International Journal of 

Rehabilitation Research. 39(4):308-312. 

4. Functional Magnetic Resonance Imaging (fMRI) Analysis: I have applied statistical methods for fMRI data 

analysis to investigate brain functions so that we can better understand the neurological and psychological 

changes associated with psychiatric disorders. 

a. Hill S.Y., DeBellis M.D., Keshavan, M.S., Lowers L., Shen S., Hall J., and Pitts T. (2001): Right 

Amygdala Volume in Adolescent and Young Adult Offspring from Families at High Risk for Developing 

Alcoholism. Biological Psychiatry, 49: 894-905. 

D. Additional information: Research Support 

Burroughs Wellcome Fund (PI: Kimani Toussaint) 6/1/2017 – 5/31/2021 

Investigating the Mechanobiology of Cervical Remodeling Using a Novel Combination of Optical Microscopy 

and Nanoindentation. 

This project is to determine the structural and mechanical properties of cervical tissue as a function of 

gestational age by using novel imaging and mechanical metrology techniques. 

Role: Statistician 

RG 1507-05433 

National Institute of Health (PI: Jacob Sosnoff) 4/1/2016-3/31/2020 

Virtual Reality-treadmill Combined Intervention for Enhancing Mobility and Cognitive Function in Patients with 

Relapsing-Remitting Multiple Sclerosis 

This project examines the efficacy of virtual reality training combined with treadmill training on mobility, 

cognition and quality of life in persons with multiple sclerosis. 

Role: Co-I 

R01 AG052707 

National Institute of Health (PI: Sean Mullen) 9/1/2016-5/31/2021 

Cognitive Regulation Training and Exercise (CORTEX)-II with Middle-aged Adults 

This project is to compare CORTEX, a multi-faceted, general and exercise-specific cognitive training program 

(involving 20 hours of active and traditional computerized cognitive training, delivered via a training center and 

at home) to an attention-control condition involving health and wellness informational videos. 

Role: Co-I 

RG-1701-26862 

National Multiple Sclerosis Society (PI: Laura Rice) 10/1/2017-9/30/2020 

Validation of a Fall Prevention Program Among Non-Ambulatory Wheeled Mobility Device Users with Multiple 

Sclerosis 

This project is to examine the efficacy of a community-based rehabilitation educational intervention on 

management of falls in non-ambulatory individuals with MS (Multifactorial Fall Prevention Program, MFPP). 

Biosketches Page 36 
Contact PD/PI: Monson, Brian Bruce 

Role: Co-I 

Biosketches Page 37 
   

Contact PD/PI: Monson, Brian Bruce 

1. Vertebrate Animals Section

PHS 398 Cover Page Supplement OMB Number: 0925-0001

Expiration Date: 03/31/2020

Are vertebrate animals euthanized? ❍ Yes ● No

If "Yes" to euthanasia

Is the method consistent with American Veterinary Medical Association (AVMA) guidelines?

❍ Yes ❍ No

If "No" to AVMA guidelines, describe method and provide scientific justification

2. *Program Income Section

*Is program income anticipated during the periods for which the grant support is requested?

❍ Yes ● No

If you checked "yes" above (indicating that program income is anticipated), then use the format below to reflect the amount and

source(s). Otherwise, leave this section blank.

*Budget Period *Anticipated Amount ($) *Source(s)

Page 38 

Funding Opportunity Number: PAR-18-487 . Received Date: Tracking Number: GRANT12962231 2019-10-28T12:08:58.000-04:00 
Contact PD/PI: Monson, Brian Bruce 

PHS 398 Cover Page Supplement

3. Human Embryonic Stem Cells Section

*Does the proposed project involve human embryonic stem cells? ❍ Yes ● No

If the proposed project involves human embryonic stem cells, list below the registration number of the specific cell line(s) from the

following list: http://grants.nih.gov/stem_cells/registry/current.htm. Or, if a specific stem cell line cannot be referenced at this time,

check the box indicating that one from the registry will be used:

❏ Specific stem cell line cannot be referenced at this time. One from the registry will be used.

Cell Line(s) (Example: 0004):

4. Inventions and Patents Section (Renewal applications)

*Inventions and Patents: ❍ Yes ● No

If the answer is "Yes" then please answer the following:

*Previously Reported: ❍ Yes ❍ No

5. Change of Investigator/Change of Institution Section

❏ Change of Project Director/Principal Investigator

Name of former Project Director/Principal Investigator

Prefix:

*First Name:

Middle Name:

*Last Name:

Suffix:

❏ Change of Grantee Institution

*Name of former institution:

Page 39 

Funding Opportunity Number: PAR-18-487 . Received Date: Tracking Number: GRANT12962231 2019-10-28T12:08:58.000-04:00 
 

Contact PD/PI: Monson, Brian Bruce 

PHS 398 Modular Budget

OMB Number: 0925-0001

Expiration Date: 03/31/2020

Budget Period: 1

Start Date: 07/01/2020 End Date: 06/30/2021

A. Direct Costs

Direct Cost less Consortium Indirect (F&A)*

Consortium Indirect (F&A)

Total Direct Costs*

Funds Requested ($)

B. Indirect (F&A) Costs

Indirect (F&A) Type Indirect (F&A) Rate (%) Indirect (F&A) Base ($)

1. MTDC

2.

3.

4.

Cognizant Agency Office of Naval Research (ONR) Sharon Gales

(Agency Name, POC Name and Phone Number)

Indirect (F&A) Rate Agreement Date 12/21/2017 Total Indirect (F&A) Costs

Funds Requested ($)

C. Total Direct and Indirect (F&A) Costs (A + B) Funds Requested ($)

Page 40 

Funding Opportunity Number: PAR-18-487. Received Date: 

2019-10-28T12:08:58.000-04:00 

Tracking Number: GRANT12962231 
 

Contact PD/PI: Monson, Brian Bruce 

PHS 398 Modular Budget

Budget Period: 2

Start Date: 07/01/2021 End Date: 06/30/2022

A. Direct Costs

Direct Cost less Consortium Indirect (F&A)*

Consortium Indirect (F&A)

Total Direct Costs*

Funds Requested ($)

B. Indirect (F&A) Costs

Indirect (F&A) Type Indirect (F&A) Rate (%) Indirect (F&A) Base ($)

1. MTDC

2.

3.

4.

Cognizant Agency Office of Naval Research (ONR) Sharon Gales

(Agency Name, POC Name and Phone Number)

Indirect (F&A) Rate Agreement Date 12/21/2017 Total Indirect (F&A) Costs

Funds Requested ($)

C. Total Direct and Indirect (F&A) Costs (A + B) Funds Requested ($)

Page 41 

Funding Opportunity Number: PAR-18-487. Received Date: 

2019-10-28T12:08:58.000-04:00 

Tracking Number: GRANT12962231 
 

Contact PD/PI: Monson, Brian Bruce 

PHS 398 Modular Budget

Budget Period: 3

Start Date: 07/01/2022 End Date: 06/30/2023

A. Direct Costs

Direct Cost less Consortium Indirect (F&A)*

Consortium Indirect (F&A)

Total Direct Costs*

Funds Requested ($)

B. Indirect (F&A) Costs

Indirect (F&A) Type Indirect (F&A) Rate (%) Indirect (F&A) Base ($)

1. MTDC

2.

3.

4.

Cognizant Agency Office of Naval Research (ONR) Sharon Gales

(Agency Name, POC Name and Phone Number)

Indirect (F&A) Rate Agreement Date 12/21/2017 Total Indirect (F&A) Costs

Funds Requested ($)

C. Total Direct and Indirect (F&A) Costs (A + B) Funds Requested ($)

Page 42 

Funding Opportunity Number: PAR-18-487. Received Date: 

2019-10-28T12:08:58.000-04:00 

Tracking Number: GRANT12962231 
Contact PD/PI: Monson, Brian Bruce 

PHS 398 Modular Budget

Cumulative Budget Information

1. Total Costs, Entire Project Period

Section A, Total Direct Cost less Consortium Indirect (F&A) for Entire Project Period ($)

Section A, Total Consortium Indirect (F&A) for Entire Project Period ($)

Section A, Total Direct Costs for Entire Project Period ($)

Section B, Total Indirect (F&A) Costs for Entire Project Period ($)

Section C, Total Direct and Indirect (F&A) Costs (A+B) for Entire Project Period ($)

2. Budget Justifications

Personnel Justification Personnel_Justification.pdf

Consortium Justification Consortium_Justification_Carle.pdf

Additional Narrative Justification

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2019-10-28T12:08:58.000-04:00 

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Personnel Justification 

Brian Monson, PhD, Principal Investigator (5 calendar months effort, salary support requested for 2.85 

summer months). Dr. Monson is an Assistant Professor in the Department of Speech & Hearing Science at the 

University of Illinois at Urbana-Champaign. Dr. Monson will assume primary responsibility and scientific 

leadership of the proposed project. Dr. Monson’s responsibilities will include training and oversight of training 

research staff for data collection and analysis, and presenting and publishing study findings. Dr. Monson will 

also assume responsibility for administering parent surveys outlined in the research protocol. Dr. Monson has 

experience with training and ongoing supervision of research personnel for data collection and analysis, as 

well as experience in the administration of clinical research for infants born premature. This, along with his 

expertise in acoustical measurements, neuroscience, and brain development demonstrate his ability to 

independently contribute and assume full responsibility for the project. 

Derrick Rollo, DO, Co-Investigator (0.36 calendar months effort). Dr. Rollo is an attending neonatologist at 

Carle Foundation Hospital with over 13 years of experience as a physician. He also has past research 

experience and an established collaborative relationship with the PI. Dr. Rollo will provide clinical guidance to 

the project and also oversee the collection of NICU data proposed in this project. Dr. Rollo will be a key liaison 

for recruitment of patients in the clinical studies from the hospital floor. 

Carolyn J. Brown, PhD, Consultant (no salary support requested). Dr. Brown is a Professor in the 

Department of Speech Pathology and Audiology at the University of Iowa. She is a leading researcher with a 

long publication list and expertise in auditory evoked potentials and pediatric audiology. Quarterly meetings will 

be held with Dr. Brown to review progress and discuss audiological data. We are requesting funds for Dr. 

Brown’s consultant fee. 

Sophie E. Ambrose, PhD, Consultant (no salary support requested). Dr. Ambrose is a Staff Scientist and the 

Coordinator of the Clinical Measurement Program at Boys Town National Research Hospital. She has 

expertise in LENA device use and LENA data analysis. She is an expert on infant vocalization and language 

development and co-developer of the Vocal Development Landmarks Interview parent report tool. Quarterly 

teleconference meetings will be held with Dr. Ambrose to review progress and discuss LENA data. We are 

requesting funds for Dr. Ambrose’s consultant fee. 

Brittney Reidy, AuD, Clinical Pediatric Audiologist (2.2 calendar months effort). Dr. Reidy is a Clinical 

Assistant Professor in the Department of Speech & Hearing Science at the University of Illinois at UrbanaChampaign. Dr. Reidy has expertise in obtaining auditory brainstem responses (ABR) and other audiological 

data from infants, with over 10 years of pediatric audiology experience. On a weekly basis, Dr. Reidy will 

conduct and oversee all clinical audiological assessments and ABR data collection for the infants at 3 months 

of age. 

Sa Shen, PhD, Biostatistician (0.5 calendar months of salary support in Year 2 and Year 3 are requested). 

Dr. Shen will provide assistance with data analysis and interpretation for the proposed project. Dr. Shen is the 

Director of Biostatistics for the Center for Health, Aging and Disability at the University of Illinois at UrbanaChampaign. Critical to the present proposal, Dr. Shen brings expertise in experimental design and analysis of 

longitudinal data. 

TBD Graduate Research Assistant (salary support requested for 9 academic months [with tuition remission] 

and 3 summer months [hourly]). A TBD 30%-time graduate research assistant will be recruited and hired to 

assist with participant recruitment, participant scheduling, data collection, and data analysis. Tuition remission 

is assessed at 64% of GRA salaries. 

Personnel Justification Page 44 

 

 

Contact PD/PI: Monson, Brian Bruce 

PHS 398 Research Plan OMB Number: 0925-0001

Expiration Date: 03/31/2020

Introduction

1. Introduction to Application

(for Resubmission and Revision applications) Introduction_to_Application.pdf

Research Plan Section

2. Specific Aims

3. Research Strategy*

4. Progress Report Publication List

Specific_Aims.pdf

Research_Strategy.pdf

Other Research Plan Section

5. Vertebrate Animals

6. Select Agent Research

7. Multiple PD/PI Leadership Plan

8. Consortium/Contractual Arrangements

9. Letters of Support

10. Resource Sharing Plan(s)

11. Authentication of Key Biological and/or

Chemical Resources

Letter_of_Intent_Carle.pdf

Letters_of_Support.pdf

Resource_Sharing_Plan.pdf

Appendix

12. Appendix

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Contact PD/PI: Monson, Brian Bruce 

Introduction 

We appreciate the helpful comments from all three reviewers. For reference, reviewer scores are shown in the table. We have addressed 

the critiques, as outlined below, resulting in a much stronger proposal. Sections where revisions were made are indicated throughout by vertical bars in the left margin. 

SIGNIFICANCE. Auditory input vs. other factors. We agree with Reviewer 3 that it will be challenging to 

distinguish between effects of auditory input vs. other sensory input vs. other medical factors (e.g., nutrition) on 

developmental outcomes. This proposal represents a critical first step to tackling this issue by providing presently 

unavailable data on NICU auditory input. We will collect many other medical factors. Although capturing comprehensive sensory input is not feasible, we will document infant skin-to-skin time as a somatosensory variable. 

We will track patients’ transition from our NICU’s low-lighting unit, to main unit while still in a covered incubator 

(allowing medium lighting), to main unit in an open crib (regular lighting). We can use these transitions to mark 

increased luminance and visual input. We will also document the use of blindfolds, which sometimes occurs. We 

will document nutrition type (mother’s breast milk vs. donor milk vs. formula) and drug administration, which we 

will use as covariates in our statistical models. We have added these clarifications to our proposal. Other. Other 

critiques raised under SIGNIFICANCE were also raised under APPROACH and are addressed below. 

INVESTIGATOR. As suggested, we increased PI effort from 3 months to 5 months. We also added a consultant with additional expertise in LENA data analysis, as well as infant vocal and communication development. 

INNOVATION. Following suggestions from Reviewers 1 and 2, we modified Aims 1A (removed analysis of 

noise), 1B (changed to a time-varying analysis of circadian patterns), and 2 (specified tone burst ABRs only) to 

omit predictable results. We added that, due to our modified approach for Aim 2, we will be collecting normative 

ABR data at 6 and 8 kHz for infants. There has been a surge of interest in the perceptual value of these high 

frequencies due to emerging evidence that very high frequencies play a larger role in speech perception than 

previously believed. Having high frequency data for full-term and preterm infants will be an important contribution. 

APPROACH. Preterm infant vocalizations. We share the reviewers’ concerns regarding LENA’s accuracy 

in detecting preterm infant vocalizations. We removed this analysis due to this technological limitation. With 

Reviewer 1’s suggestion to use LENA metrics as covariates for ABRs, and based on new evidence from preliminary data, we modified Aim 3 to assess the relationship between perinatal language exposure and ABR latencies 

rather than vocalizations. Aim 2. We incorporated Reviewer 1’s suggestions (changed the ABR protocol to only 

2 click levels; added rationale for a potential frequency-dependent vulnerability; prioritized data collection at 6 

and 8 kHz; and clarified that we obtain thresholds for infants with no responses at 25 dBnHL). With this approach 

we have successfully collected preliminary data at all frequencies for 11 of 12 infants. Intrauterine acoustic 

environment. We apologize that we did not adequately convey our considerations on this important topic previously. We now include them. We think the reviewers’ comments reflect the commonly held belief that the intrauterine transfer function is a low-pass filter. Although it has been reported that this function approximates a lowpass filter, both human and animal data suggest maximal attenuation at high frequencies is less than 20 dB.1 2 

The available human data indicate large intersubject variability, with some women’s transfer functions exhibiting 

level gains for bands up to 2 kHz.1 Only one subject displayed attenuation >5 dB at all frequency bands from 1 

to 8 kHz. Animal and synthetic models reveal that the filter is also highly dependent upon the receiver location.2 

3 Absolute frequency-band level estimates for the intrauterine noise floor indicate it is dominated by low-frequency (<200 Hz) cardiovascular and digestive sound sources.4 Thus the common belief that fetuses have no 

access to spectral information at higher frequencies deserves some reconsideration. There is frequency-dependent maturation of the auditory system5 and a direct fluid acoustic pathway to the inner ear that will further 

constrain what the fetus actually hears. However, it appears clear that at least voice,6 pitch,7 vowel formant,

8 and 

temporal information are available to and learned by the fetus,9 and that fetuses can hear at least 3-kHz tones10 

and 5-kHz octave bands11 at later gestational ages. Given these data and constraints, we believe the safest 

assumption is that fetuses have access to much spectral information much of the time. Nonetheless, we propose 

to apply a uterine filter to our recordings based on mean values from humans,

1 and then exclude any audio that 

falls below the putative uterine noise floor at all frequency bands. Other. A comparison of incubator and womb 

transfer functions is now included as suggested (Fig. 3). We clarified that we will document use of respiratory 

devices during our recordings. Data labelled “Silence” during use of nasal cannulas will be relabeled as “Noise.” 

We included sex effects in the speech exposure analysis and infant sex as a covariate for our ABR analysis. 

GENERAL. We recognize that a study of this nature will have some limitations. In spite of these limitations, 

the Aims of the present proposal will yield subject-specific NICU sound exposure data, typical fetal extrauterine 

language and sound exposure data, and normative 6- and 8-kHz tone burst infant ABR data, all of which are 

presently unavailable. We feel that access to these valuable data warrants the proposed efforts. 

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Contact PD/PI: Monson, Brian Bruce 

Being reared in abnormal acoustic environments results in detrimental effects on auditory brain development. 

Animal studies clearly demonstrate this principle, revealing particularly dire consequences when the abnormal 

auditory experience occurs during critical periods of neurodevelopment. Perhaps nowhere are these findings 

more alarmingly relevant for humans than for premature infants in the neonatal intensive care unit (NICU). During 

a period of rapid auditory and brain development that would ordinarily occur in utero, preterm infants are deprived 

of the intrauterine environment, including the highly unique intrauterine sounds. Relative to the womb, the NICU 

imposes drastic changes to perinatal auditory input, including high (potentially noxious) sound levels, a change 

in the transmission medium (air vs. fluid), and replacement of constant biological sounds (e.g., mother’s voice 

and heartbeat) with non-biological sounds (e.g., electronic alarms and mechanical noise) and periods of silence. 

Because humans have precocial hearing, preterm infants are listening to and learning about these surrounding 

sounds. Medical advances have dramatically improved survival rates for preterm infants, but long-term 

morbidities, including speech, language and auditory deficits, are widely reported. To what extent are these 

deficits a result of abnormal perinatal auditory input? 

Our understanding of the impact of NICU auditory exposures on human communication development is limited. 

The need to improve this understanding is urgent; within the United States alone, over 500,000 infants are born 

premature each year, with most spending time in the NICU. Indeed, the preterm infant is a prime target for 

NIDCD’s stated priorities to (1) “define the underserved population of infants and children for hearing health care” 

and (2) “develop...new effective interventions and approaches tailored for understudied populations or 

conditions.” In the current proposal, we focus on this underserved population, with the long-term goal of 

developing interventions designed to optimize auditory experience for premature infants. 

Critical barriers to achieving this long-term goal are (1) the lack of adequate information about the present 

auditory experience for the premature infant, and (2) the lack of comprehensive data on auditory outcomes for 

this population. With our team’s expertise in newborn medicine, neuroscience, acoustics, pediatric audiology, 

and communication development, we are uniquely positioned to address these two barriers. We will focus on 

capturing auditory exposures and medical course for each infant throughout NICU stay. We then propose to 

evaluate the effects of NICU auditory exposures on infant auditory pathway development. Our approach will be 

divided into three Specific Aims. 

Aim 1: Determine the difference between intrauterine and NICU auditory exposures for human infants 

Comprehensive auditory experience will be captured for very preterm (VPT) infants and typically developing 

fetuses using small 24-hr audio recording devices (LENA). For VPT infants, LENA devices will be placed in the 

incubator or crib to reside with the infant. For fetuses, LENA devices will be worn near the abdomen of the 

pregnant mother. Recordings will be obtained multiples times per week. Three hypotheses will be tested: 

A. Language exposure in the NICU is less than that experienced in utero. 

B. Language, noise, and other sound exposures follow a circadian pattern for fetuses, but not for VPT infants. 

C. Exposure to sounds ≥400 Hz in the NICU increases with time between birth and discharge as VPT infants 

transition from enclosed infant incubators (less stable condition) to open cribs (more stable condition). 

Rationale: These hypotheses derive primarily from observations made with our preliminary data. 

Aim 2: Determine the effect of VPT birth on auditory neurodevelopment 

VPT and full-term (FT) infants will undergo diagnostic auditory brainstem responses (ABR) at 52 weeks 

postmenstrual age (PMA; i.e., 12 weeks after full term equivalent age). Hypothesis: 

A. VPT birth leads to longer latency tone burst ABRs at 52 weeks PMA. 

Rationale: Studies have demonstrated auditory pathway maturation is delayed by VPT birth. 

Aim 3: Determine the relationship between perinatal auditory exposures and auditory neurodevelopment

The relationship between perinatal auditory exposure metrics and auditory brainstem development at 44 weeks 

and 52 weeks PMA will be assessed. Hypothesis: 

A. Greater language exposure during perinatal brain development leads to more rapid auditory 

neurodevelopment. 

Rationale: This hypothesis stems directly from our preliminary data and observations. 

Only when we fully understand the relationship between perinatal auditory experience and later communication 

outcomes will we be able to introduce personalized, effective therapies to optimize that experience and improve 

outcomes for this fragile population. The proposed Aims are first steps critical to this understanding and will 

provide a treasure trove of much needed data that will yield important contributions for years to come. 

Furthermore, the proposed study will lay the foundation for an R01 proposal aimed to assess long-term 

communication and neurodevelopmental outcomes for this cohort of VPT infants during longitudinal follow-up. 

Specific Aims Page 48 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contact PD/PI: Monson, Brian Bruce 

Significance

Prenatal auditory function. Humans are altricial mammals with precocial hearing. In contrast with many other 

altricial mammalian species, nature has deemed human prenatal auditory experience of sufficient value to 

warrant the activation of auditory function as early as 25 weeks postmenstrual age (PMA), some 15 weeks prior 

to full-term (FT) birth.10 12-14 What are fetuses hearing? 

The prenatal acoustic environment is unique, with the endogenous noise floor dominated by constant lowfrequency sources of mother’s cardiovascular and digestive sounds transmitted via amniotic fluid.15-17 Also 

present are the sounds of mother’s vocalizations, as well as extrauterine vocalizations, music, and other airborne 

sounds that impinge on the abdomen of the mother and exceed the endogenous noise floor.17 18 The extrauterine 

airborne sounds are filtered by the extra-to-intrauterine transfer function, which can attenuate higher frequencies 

more than low frequencies, although maximal attenuation tends to be only ~15 dB observed at 4 kHz, with less 

attenuation at 8 kHz.1 2 The available human data indicate large intersubject variability, with some women’s 

transfer functions exhibiting level gains for frequency bands up to 2 kHz.1 Animal and synthetic model data reveal 

that the transfer function is also highly dependent upon the receiver location in the uterus.2 3 Thus fetuses have 

access to much spectral information from extrauterine sounds, although which frequency bands are most 

prominent can depend greatly upon maternal anatomy, sound source location, and fetal head location. Further 

constraining what fetuses actually hear is the direct fluid acoustic pathway to the inner ear, which could bypass 

typical middle ear function,9 and the frequency-dependent maturation of auditory sensitivity, which begins during 

fetal development and continues into childhood.5 For example, fetuses first demonstrate behavioral responses 

to extrauterine low-frequency tones (≤500 Hz) around 25 weeks PMA, with responses to 1- and 3-kHz tones 

developing around 32 weeks PMA.10 Remarkably, the immature fetal brain possesses capabilities for auditory 

learning and memory of extrauterine sounds. FT newborns exhibit behavioral and neurophysiological responses 

that distinguish between acoustic stimuli to which they were exposed in utero (e.g., mother’s voice) and novel 

stimuli (e.g., stranger’s voice).6-8 19-22 Thus it seems clear that at least voice,6 pitch,7 vowel formant,8 and temporal 

information is available to and learned by the fetus,

9 and is likely more prominent for male than female voices.18 

Less clear is whether prenatal auditory experience has lasting effects on auditory development or communication 

behavior. Though there exist reports that loud noise exposures for pregnant mothers are associated with hearing 

loss in their newborns,23 24 these findings have been criticized due to methodological shortcomings.15 25 Animal 

studies have documented hearing loss in fetuses that were exposed prenatally to sound pressure levels (SPL) 

in excess of 115 dB SPL for extended periods,26 27 but such levels and durations are beyond that of typical 

human exposures. Prenatal hearing and auditory learning is facilitated by a neural pathway mature enough to 

permit cochlear input to reach at least primary and nonprimary auditory cortical regions.21 28 29 The role of 

experience generally in shaping this pathway has been well established. Animal models clearly indicate that 

normal auditory circuit development is dependent on extrinsic auditory stimulation.30 Thus degradation or 

deprivation of acoustic information during critical developmental periods has lasting detrimental neural and 

behavioral consequences.31 This principle has been demonstrated for early deafness in humans with cochlear 

implants32 33 and in animal models of early deafness,34 35 temporary hearing loss,36 37 and acoustic enrichment.38 

Normal hearing animals reared in unnatural acoustic environments (e.g., hearing only white noise) exhibit 

marked abnormalities in auditory cortex.39 Normal hearing animals deprived of conspecific vocalizations during 

critical learning periods also exhibit neural abnormalities and communication deficits.40 Auditory cortex maps in 

mice are influenced by acoustic input within days after hearing onset.41 Notably, these studies have largely been 

conducted following FT birth of the animals, albeit shortly after hearing onset. Here we propose to examine 

human auditory experience prior to FT age. 

Preterm birth: clinical significance. If intrauterine auditory experiential benefits warrant prenatal auditory function 

and learning, what are the effects of disrupting that auditory experience with preterm birth? 

Nowadays infants born as early as 23-24 weeks’ gestation often survive to 

adulthood with modern medical care. These infants undergo a rapid and 

premature change in auditory input as they transition to the acoustic 

environment of the neonatal intensive care unit (NICU). Here they are 

exposed to high sound levels,42 unnatural electronic and mechanical 

noises,43 and periods of silence,43 44 all transmitted via air rather than fluid 

(see the Table). Preterm infants suffer from a high incidence of 

neurodevelopmental problems,45 many of which are linked with auditory 

function. For example, the preterm population has a relatively high 

incidence of sensorineural hearing loss (approx. 1.5%, compared to 0.1-0.3% for healthy infants)46-49 and 

51 53 auditory neuropathy,50 as well as central auditory processing disorder.52 Even preterm infants with no 

Research Strategy Page 49 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contact PD/PI: Monson, Brian Bruce 

diagnosis of auditory pathology exhibit cognitive impairments related to audition, including auditory attention 

deficits54 and widely reported speech/language comprehension and production deficits.55-57 Neural mechanisms 

underlying these impairments are not clear, although central mechanisms have been implicated since cochlear 

function measured with otoacoustic emissions (OAEs) appears to be similar between term-born infants and 

58 59 preterm infants at term-equivalent age. Auditory brainstem response (ABR) latencies indicate auditory 

pathway maturation is delayed for preterm infants at term-equivalent age.60-64 Some have attributed this group 

difference in ABR latencies to possible conductive loss in the preterm population.64 65 Differences between 

cortical evoked potentials for term and preterm infants have also been reported.

65 Perhaps related to abnormal 

cortical responses, prior work from our lab and others has revealed structural abnormalities in cortical gray and 

white matter for preterm infants with whole-brain measures66-68 and in auditory cortex specifically.69 Additionally, 

these structural abnormalities in infancy were associated with poorer language abilities later in childhood.68 69 

Now is an especially critical time to consider preterm infant auditory experience as recent changes to NICU 

design are altering this experience. Namely, a current trend in hospitals worldwide is to reconstruct open layout, 

multi-bed NICU designs into private, single-patient rooms.70 A consequence of this redesign is a substantial 

change to auditory input for NICU patients, with increased amounts of silence and decreased amounts of 

language exposure.43 Given that silence is a condition never experienced in utero (owing to the presence of 

mother’s heartbeat and other biological sounds),17 this change could have consequences for the developing 

brain. Two reports suggest that acoustic input during NICU stay might have lasting effects on communication 

skills for preterm infants. One report showed that the amount of exposure to adult speech during NICU stay 

correlated with language scores at age 7 and 18 months.

71 The other report examined very preterm infants who 

were randomly assigned to either a noisier open ward multi-bed NICU or a quieter single patient private room.72 

Contrary to the original hypothesis, language scores were poorer for the single patient room group at age 2 

years. It was proposed that the quiet conditions led to auditory deprivation. To what extent neurodevelopmental 

deficits observed for preterm infants can be explained by abnormal auditory exposures, and whether differential 

effects of auditory input vs. other biological and medical factors can be disentangled remain open and challenging 

questions. This proposal is an essential first step to begin to address these questions. 

Experiments outlined in this proposal will be focused on capturing auditory experience during the preterm 

period. Previous efforts to characterize individual preterm infants’ auditory exposures have been limited in two 

ways: 1) only two44 or four43 discrete 16-hr periods were measured to approximate auditory experience during 

NICU stay (which can last up to four months); 2) no analysis of a typically developing control group was 

conducted. Here we address these shortcomings by analyzing auditory exposures both for NICU infants and 

typically developing fetuses, making multiple 24-hr recordings per week for each participant throughout the third 

trimester of brain development. The data collected in infancy for this proposal will serve as the foundation for an 

R01 proposal aimed to collect longitudinal data on auditory and language development at ages 2 and 5 years 

in these same infants, and to relate perinatal auditory exposures to communication outcomes in childhood. 

Innovation 

Comprehensive perinatal auditory experience. Although our proposed method to measure preterm infants’ 

auditory exposures in the NICU using LENA devices has been employed by others,43 44 accurate estimates of 

comprehensive individual auditory experience are lacking due to the limited number of 16-hr recordings 

measured for each subject. In the present study we will amass an unprecedented amount of auditory exposure 

data for each subject by measuring multiple 24-hr periods per week throughout NICU stay. 

Fetal language exposures. LENA devices have been used to track language exposure for infants and children, 

but no data yet exist on language exposure for typically developing fetuses. This study will provide these data. 

Effects of perinatal auditory experience. Theory holds that abnormal perinatal auditory input influences early 

brain development, as indicated by animal models. The data collected here will provide a rare opportunity to 

assess the effects of altered perinatal auditory input on brain development in humans. 

Normative ABR data at 6 and 8 kHz. There is growing interest in incorporating 6- and 8-kHz tone bursts with 

diagnostic ABRs for infants, but normative data are not yet widely available. We will collect these data. 

Approach 

Aim 1: Determine the difference between intrauterine and NICU auditory exposures for human infants 

General Methods: Power analysis. Our preliminary study on NICU auditory exposures (see Experiment 1A 

below) had an effect size >1.0. A previous study on NICU auditory exposures showed a smaller effect size of 

0.48.

43 A sample size of 69 subjects per group yields power of 0.80 to detect the smaller effect size of 0.48. 

Participants. The preterm group will consist of 100 very preterm (VPT) infants (born <32 weeks’ gestation). We 

focus on VPT infants because risks for impaired neurodevelopment increase substantially for VPT infants. 

Participant families will be recruited from the Carle Foundation Hospital NICU in Urbana, Illinois. Infants will be 

Research Strategy Page 50 
Contact PD/Pl: Monson, Brian Bruce 

excluded if they have a known or suspected congenital anomaly, infection, or prenatal brain lesion. On average, 

the Carle NICU admits >120 VPT infants annually. During our pilot phase, we recruited more than one VPT infant 

per week. We estimate recruitment of 50 VPT infants annually. The control group will consist of 100 healthy 

pregnant women <32 weeks pregnant and their FT babies. Participants will be recruited from the UrbanaChampaign community and will be compensated for participation. Data collected from subjects who ultimately 

undergo premature labor (<37 weeks) will be excluded. 

NICU auditory exposures and medical factors. The following procedures are approved by the Carle NICU 

research and nursing staff and do not interfere with medical care practices (see Letter of Support from Co-I Dr. 

Rollo). A LENA device, which is a small 2-oz recording device capable of capturing 24 hours of high-fidelity, 

calibrated continuous audio data, will be adhered to the inside wall of the infant's incubator or crib, near the head 

of the infant. Each 24-hr LENA recording will be processed with an automated classification algorithm that 

calculates the durations of different sound categories: language, electronic sounds, noise, and silence.73 74 

Recordings will be made three times per week throughout NICU stay. While infants in our NICU are generally 

treated within the incubator or crib, they are removed for skin-to-skin sessions with a parent. When the infant is 

removed for skin-to-skin, the nurse will remove the device and adhere it to the armchair, near the infant's head. 

Infant medical factors will be collected to include as covariates for statistical analyses, including: 

characterization of labor, delivery, and resuscitation; data on respiratory, cardiovascular, nutritional, and 

infectious disease care, including respiratory device use; growth of the infant; length of NICU stay; use of 

blindfolds; transitions to environments with greater lighting; and cranial ultrasound findings. Particular attention 

will be given to bilirubin levels and ototoxic drug (e.g., gentamicin, furosemide) administration as these factors 

have known associations with hearing loss.75 76 Maternal characteristics will be documented, including maternal 

age, marital status, socioeconomic status, level of education, prenatal drug exposure, family structure and 

maternal medical history. All preterm infants undergo routine ABR hearing screening prior to discharge from the 

NICU. Hearing screening results will be documented. 

Parent presence and skin-to-skin care will be documented in two ways. First, a daily parent care log stored 

at the bedside will be used to record the frequency and duration of parental presence and holding. Parents will 

be asked to complete this log, with assistance from the nurse as needed. This information will be supplemented 

by each infant's electronic medical record, in which nurses document parents' visits and activities. 

Fetal auditory exposures. A LENA device attached to a necklace will be worn around the neck so as to be near 

the abdomen of the pregnant female subject for a 24-hr period. Any necessary removal of the device lasting 

more than five minutes (e.g., to shower) will be documented by the subject. During sleep, the LENA will be placed 

at the bedside. Recordings will take place twice per week throughout the third trimester of pregnancy. 

Compliance will be assessed with periodic reminder alerts to and from the participant via instant messaging. 

Extrauterine recordings may not reflect actual intrauterine exposures. Because the LENA can be calibrated to 

provide absolute intensity levels, we will apply a womb-like filter to our recordings1 and remove any data where 

all spectral levels are below the putative noise floor of the womb. 

Parental and family factors. Parents in both study groups will be surveyed about a range of pregnancy- and 

family-related issues, including pregnancy history; maternal age; family social, educational, and economic 

circumstances; parental perceptions of stress in the NICU or during pregnancy; and maternal anxiety/depression. 

Experiment 1A ., ~: VPT Fetal 

Hypothesis: Language exposure in the NICU is less than that £ u 

experienced in utero. :g. 

Premise and rationale: Our approach follows from our preliminary data ~ 

10 

8 

I 

i; 6 (Fig. 1 ). Fetal data were collected from 12 pregnant women who wore .?- 4 I 

the LENA device twice per week for up to 14 weeks during the third ~ 2 II I I 

trimester, accruing ~7000 hrs of data. VPT data were collected from 9 ° Speech Electr~ ics Airborne Silence HeartbeaV 

VPT infants with LENAs placed in their incubators/cribs thrice per week Noise i:!:9~"n';~ 

for up to 8 weeks, accruing ~2600 hrs of data. Average daily language Figure 1 Average dally auditory exposures for VPT 

exposures for VPT and fetal groups were 3.1 and 4.5 hrs, respectively. infants and for typically developing fetuses 

These observations are significant for two reasons. First, although it is presumed that language exposure in 

the NICU is low,43 44 language exposure for typically developing fetuses has been unknown. These data indicate 

~45% greater language exposure for fetuses than for VPT infants. Second, these data highlight the changes to 

auditory input for VPT infants. For example, airborne noise exposure increases by a factor of 2.5 for VPT infants 

(see Fig. 1 ). VPT infants spend 11.5 hrs per day in silence, a condition that never occurs in utero. Fetal exposures 

during extrauterine silence consist of low-frequency biological sounds of heartbeat, digestion, etc.17 

Experimental Design: We will determine daily auditory exposures for VPT infants and fetuses using the data 

Research Strategy Page 51 
Contact PD/Pl: Monson, Brian Bruce 

collection procedure outlined above. We will test for group differences in mean daily language exposure using a 

linear mixed-effects model. We will control for socioeconomic status and maternal education level in our model. 

We will also test for group differences in the proportion of male vs. female speech exposure. Talker sex effects 

have been reported for infants in the home,77 but it is unknown whether effects hold for fetuses or VPT infants. 

Expected Outcome: This experiment will establish the nature of auditory exposures for typically developing 

fetuses, offering a comparison for auditory exposures for our VPT group. Based on our preliminary data, we I expect to find greater exposure to language for fetuses. These data will also allow us to characterize other 

potential differences between our groups (e.g. , electronic sounds) and/or trends within group (e.g., change in 

daily language exposure for fetuses over time). 

Limitations and Alternative Plans: We have found success with our approach for preliminary data collection. One 

challenge is that a LENA in an incubator may not capture sounds of nasal cannulas which generate sound at the 

infant's ear. We will document use of respiratory devices and will relabel periods of "Silence" during respiratory 

device use as "Noise." We can also assess SPL exposure with these data. Language 30 

Experiment 1 B c 

g 20 Hypothesis: Language, noise, and other sound exposures follow a circadian ~ 

pattern for fetuses, but not for VPT infants. I 1

0 

Premise and rationale: The evidence for this hypothesis comes from our ~ 

preliminary observations (Fig. 2). We conducted a time-varying analysis of o .i,,...- .=i;::::...._ _____ ---=::,;;.. 

12AM 6AM 12PM 6PM hourly language, airborne noise, and total extrauterine sound exposure for 3 Noise 

fetuses and 3 preterm infants, averaging across at least twenty 24-hr cycles 30 ', ,... , 1 , ,. '2 ., , .... , ,,, / 

for each subJ·ect. Whereas language, airborne noise, and total extrauterine :e::.~ ,. ,' -

1.._,.. L 1 , -~v ' ' >~-"' \ \, ,- SOUnd exposure cycles for fetuses (solid lines) showed a marked circadian ~ : ~ - '.,'°, ' ' ~ - -

pattern, with low exposure during nighttime hours, VPT infants (dashed lines) ~ 10 - '- ',. '-'° - ,. ,. ' - ' , -

showed little change across the cycle. To quantify this pattern, we calculated w oL - =5i.~:::::;::§::::::;~~ 

a "circadian index" for each subject and each category as the proportion of 12AM 

total daily exposure occurring during the most "active" 16-hr window. Mean eo 

circadian indices across 3 fetuses were 0.99, 0.94, and 0.97 for language, c 

noise, and total sound exposure, respectively. Mean indices across 3 VPT f-10 

infants were 0.75, 0.70, and 0.68 for these respective categories. 120 

Although light/dark (visual) cycles have been studied in the NICU and in 

6AM 12PM 6PM 

Total Sound 

have been shown to affect health outcomes,7a-ao these preliminary results o-i=-.....:c...i..(.'----------=- 12AM 6AM 12PM 6PM 

demonstrate a lack of acoustic circadian rhythms for NICU infants. Such Time 

d t

. d"ff b tw VPT · f t d f t t "k" b Figure 2 Average 24 hr exposure cycle for rama Ic I erences e een in ans an e uses ares n mg ecause, language(top) nolse(mlddte)andallextra 

absent maternal hormonal signals important for the typical fetal brain to uterine sounds (bottom) for 3 fetuses (solid 

develop a circadian rhythm during the third trimester of gestation, 

81 acoustic lines) and 3 VPT Infants (dashed lines) 

stimuli, along with visual stimuli, could potentially serve as a useful compensatory sensory cue for entrainment 

to a circadian rhythm.80 It is important to note that nighttime hours for the fetus are not silent, but sounds are 

limited primarily to low-frequency cardiovascular and other biological sounds. It is not clear what direct influence, 

if any, extrauterine acoustic circadian rhythmic activity has on the fetus. 

Experimental Design.· We will test for group differences in circadian indices for language exposure, airborne 

noise exposure, and total extrauterine sound exposure using multiple linear regression models. 

Expected Outcome: We expect to find an increase in circadian proportions for our fetal group. Because we are 

documenting parental presence and skin-to-skin care, our data will also allow us to characterize circadian trends 

in these variables (e.g., if mother visits at the same time each day). It may be that increased parental presence 

is associated with increased language exposure. 

Limitations and Alternative Plans: Since VPT infants in our NICU spend the majority of their time in the incubator 

or crib (including for diaper changing, cares, etc.), the LENA should provide an accurate account of auditory I exposures. VPT infants are removed for skin-to-skin care, and the LENA will be moved and adhered to the 

parent's chair when this occurs. Infants may be moved for other procedures that preclude data collection during I that period of time (e.g., MRI). These procedures and time away from LENA will be documented. Any period 

away from the LENA lasting longer than five minutes will be excluded from analysis. The LENA sound 

classification algorithm has been tested and validated, showing good correspondence with ratings from trained 

listeners,

73 74 but we can conduct our own validation. Because VPT infants spend a large percentage of time 

sleeping,82 many exposures occur during sleep. We recognize that it is not yet clear what differential effects 

auditory exposures may have during sleep vs. wakefulness for VPT infants (or fetuses). 

Experiment 1 C 

Research Strategy Page 52 
Contact PD/Pl: Monson, Brian Bruce 

I Hypothesis: Exposure to sounds ~400 Hz in the NICU increases with time between birth and discharge as VPT 

infants transition from enclosed infant incubators (less stable condition) to open cribs (more stable condition). 

10 

Premise and rationale: We assessed the transmission of sound into 

NICU incubators (i.e., the transfer function) by conducting spectral 

analysis of simultaneous internal and external recordings of white 

noise and conversational speech presented over a loudspeaker 

located external to the incubator (Fig. 3). As expected, the analysis CO -10 revealed nonuniform attenuation as a function of frequency. Greatest :Q. 

C: attenuation of ~25 dB was at 400 Hz, with attenuations ranging 10-25 ·ro 

C!l·20 dB for frequencies beyond ~500 Hz. The measured transfer function 

INCUBATOR 

was fairly consistent across loudspeaker locations around the 

.30 -~--------- incubator. For comparison with extra-to-intrauterine transfer functions, 102 103 104 

previously published mean data measured in humans (green) and Frequency (Hz) 

sheep (dashed lines) are plotted in Fig. 3. Figure 3 Transfer functions of Incubator and womb 

Separate Incubator measurements were made with 

These findings are of interest because it has been proposed that noise or speech source located on the left front or 

the NICU imposes an overexposure to very high frequencies,

83 rightside Uterlnefunctlonstakenfromdatameasured 

whereas in the womb these frequencies may be at least somewhat ._1_n_hu_m_a_ns_'_(g_ree_ nJ_a_n_d_sh_ee_p_

2

_(d_a_sh_ed_ 1_

1

n_es_) _ __, 

attenuated. These data reveal that this assertion may only hold for later PMAs when preterm infants have 

graduated from the incubator to an open crib. This analysis also suggests a potential acoustical benefit of NICU 

incubators. It may be that this sound attenuation is a protective influence over a developing auditory system from 

noxious NICU sound levels that have long been a concern.84 85 Importantly, however, our data were collected in 

unoccupied incubators, absent of other life-supporting devices that generate broadband noises (e.g., respiratory 

devices). Thus our preliminary observations require confirmation within occupied incubators. This experiment is 

designed to assess exposure to different frequency bands as a function of PMA. I Experimental Design: Third-octave band analysis will be conducted on each LENA recording for each subject 

using a previously established method with the long-term averaged spectrum.

86 This method yields average I SPLs for individual third-octave bands for each recording, permitting the tracking of low- and high-frequency 

levels throughout NICU stay. We will test for a relationship between third-octave band levels and PMA using 

linear mixed-effect models that account for correlations by allowing for nesting of repeated observations within 

third-octave band and third-octave bands within subject. 

I Expected Outcome: We anticipate that sound levels for third-octave bands ~400 Hz will increase with increasing 

PMA, while those bands <400 Hz will show little to no change over time. 

Limitations and Alternative Plans: Due to LENA hardware limitations, only spectral data out to 8 kHz can be 

recorded. Although spectral energy beyond 8 kHz is often low, we will ascertain typical levels for the 8- and 16-

kHz octave bands for our NICU using cross-sectional measurements with a sound level meter. 

Aim 2: Determine the effect of VPT birth on auditory neurodevelopment 

Hypothesis: VPT birth leads to longer latency tone burst AB Rs at 52 weeks PMA. 

Premise and rationale: It is established that click-evoked ABR latencies are longer for preterm infants than for 

FT born infants.61 63 64 This suggests disrupted maturation of the cochlea, the hair cell-auditory nerve synapse, 

and/or the auditory brainstem for preterm infants.87 Nearly all studies examining the effect of preterm birth on 

ABRs have used only click stimuli, leading to a paucity of frequency-specific information. This information is 

important to obtain because hair cells in the basal end of the cochlea are the most vulnerable to damage in many 

forms of hearing loss. Furthermore, there is reason to believe high frequencies are particularly affected in VPT 

infants. Ototoxicity and hearing loss resulting from aminoglycoside administration in children has been shown to 

largely affect high frequencies.88 In some cases, loss can only be detected using extended high-frequency 

audiometry.89 Because gentamicin (an aminoglycoside) is administered to preterm infants with infections, 

examination of the high frequencies in VPT infants is warranted. 

Experimental Design: All audiological assessments will be conducted by our pediatric audiologist. VPT and FT 

infants will return for follow-up, targeting an age of 52 weeks PMA. Standard otoscopy, tympanometry, and 

otoacoustic emissions assessments will be conducted. ABRs will be collected during natural sleep using clicks 

at 80 and 25 dB nHL, and tone bursts at 80, 50, and 25 dB nHL at 0.5, 1, 2, 4, 6, and 8 kHz for each ear. Our 

protocol is based on established methods,90 91 developed under advisement of our consultant, Dr. Brown. 

Thresholds will be obtained for infants who do not show replicable responses at 25 dB nHL. We will prioritize 

data collection for 6 and 8 kHz first, followed by lower and midrange frequencies. With our protocol, we have 

successfully collected data at all frequencies for 11 out of 12 FT babies. We will test for group differences in tone 

burst wave V latencies using linear mixed-effects models that account for correlations by allowing for nesting of 

Research Strategy Page 53 
Contact PD/Pl: Monson, Brian Bruce 

repeated observations within each ear and ears within subject. We will test for an interaction between group and 

frequency. Because our main interest is whether VPT birth affects auditory neurodevelopment in the absence of 

other pathologies, we will exclude from these analyses any infant (VPT or FT) meeting criteria for a clinical 

diagnosis of hearing loss (nHL > 25 dB). Due to potential sex effects,

92 we will control for infant sex in our models. 

Expected Outcome: We expect we will observe longer tone burst ABR latencies for VPT infants, with larger 

effects at frequencies .!:4 kHz. We suspect there will be hearing loss in our VPT group at 6 and 8 kHz due to 

ototoxic drug administration. During future follow up with this cohort (for our R01 proposal), we will also be able 

to assess the association between ABRs in infancy and childhood communication development.93 

Limitations and Alternative Plans: Obtaining non-sedated ABRs for infants requires feeding and lulling to sleep. 

It is likely we will be unable to obtain all measurements for some infants due to fussiness or other factors. As 

done with our preliminary data collection, we will leave the mid-range frequencies as our final measurements 

and schedule an additional follow-up if we experience challenges obtaining data. We may also need to decrease 

the number of levels tested. We may detect hearing loss. To rule out middle-ear pathologies, we will use otoscopy 

and tympanometry, rescheduling the ABR if the infant fails tympanometry. Infants with hearing loss will be 

excluded from our regression analysis. For ABR peak-picking reliability, we will use two blinded judges. 

Aim 3: Determine the relationship between perinatal auditory exposures and auditory neurodevelopment 

Hypothesis: Greater language exposure during perinatal development leads Averaged ABR Latencies 

to more rapid auditory neurodevelopment. w~ve v, R = -o.42 

Premise and rationale: Justification for this experiment and hypothesis stems 6 •· 

directly from our preliminary observations with ABR data collected from 11 g 

of our 12 FT infants whose mothers participated in the LENA data collection » 

g 4 described in Aim 1. Infants were brought back for ABR follow up at 52 weeks w 

PMA. The data reveal a clear trend for a relationship between greater 5 

average daily language exposure during the third trimester of gestation and 

shorter left-right averaged absolute latencies for waves I, Ill, and V obtained 

2 

Wave Ill: R = -0.45 

Wave I, R = -0.27 

with clicks at 80 dBnHL (Fig. 4). This trend held for both left and right ears 3 4 5 6 

individually as well (data not shown). These preliminary findings are striking Daily speech exposure (hr) 

because they raise the possibility that language exposure prior to birth Figure 4 Left right averaged ABR latencies for waves I (blue) Ill (red) and V (green) 

facilitates maturation of the auditory pathway for humans, with long-lasting plotted against daily speech exposure 

effects. Although the theoretical mechanism for this relationship is not clear, Shading represents 95% confidence Intervals 

animal models have demonstrated that auditory brainstem and/or cortical neurophysiology94 and absolute 

response latencies 31 95 can be modified by pre- and perinatal enriched or impoverished acoustic environments. 

Experimental Design: Although we observe an apparent relationship in our preliminary data with our FT infants, 

it is likely that 12 weeks of postnatal experience had an effect on auditory brainstem development. To mitigate 

this confound, in addition to ABR data collection at 52 weeks, we will conduct click-evoked ABRs at 44 weeks 

PMA when FT postnatal and VPT post discharge experience has less of an effect. We will test for an association 

between mean daily language exposure during the perinatal period and click-evoked ABR absolute and interpeak 

latencies at 44 weeks PMA and 52 weeks PMA using separate multiple linear regression models. We will conduct 

separate analyses for VPT infants and FT infants. For the FT group, we will control for birth gestational age and 

PMA at test date. For our VPT group, we will control for birth gestational age, PMA at test date, and other medical 

factors in our models, including length of NICU stay, ototoxic drug administration, type of nutrition (breast milk 

vs. donor milk vs. formula), and weight gain. 

Expected Outcome: We predict a relationship between perinatal language exposure and click ABR latencies. 

Limitations and Alternative Plans: We were surprised by this preliminary result and we recognize the theoretical 

mechanism for the observed relationship is not clear. The relationship was not observed for interpeak latencies. 

Nonetheless, we maintain this exploratory hypothesis as it derives directly from our pilot data. As an alternative, 

we can use SPL exposure, noise, and/or silence (for the VPT group) to predict ABR latencies. Additionally, in 

our longitudinal follow-up R01 proposal we plan to assess language/vocal development in later infancy and 

childhood using measures developed by our consultant, Dr. Ambrose.96 Perinatal exposure data collected here 

will allow us to test for relationships between perinatal language exposure and childhood language development. 

It may be challenging to bring newborns in for two ABR visits, particularly for VPT infants. At 44 weeks we will 

restrict our data collection to only click-evoked ABRs to minimize time. Alternatively, we can assess postnatal 

language exposure prior to 52 weeks by using LENAs in the infants' homes following FT birth or NICU discharge. 

General Alternative Plans: Many additional analyses could be conducted with the data collected here (e.g., 

SPL exposure and relation to outcome). Critically, the Aims will yield these valuable, much-needed, yet presently 

unavailable data for these analyses, regardless of the outcome of our present scientific predictions. 

Research Strategy Page 54 
Contact PD/PI: Monson, Brian Bruce 

PHS Human Subjects and Clinical Trials Information OMB Number: 0925-0001 and 0925-0002

Expiration Date: 03/31/2020

Are Human Subjects Involved ● Yes ❍ No 

Is the Project Exempt from Federal regulations? 

Exemption Number 

Other Requested Information 

❍ Yes 

❏ 1 ❏ 2 

● 

❏ 3 

No 

❏ 4 ❏ 5 ❏ 6 ❏ 7 ❏ 8 

Funding Opportunity Number: PAR-18-487 Received Date: Tracking Number: GRANT12962231 2019-10-28T12:08:58.000-04:00 Page 55 
1 

Contact PD/PI: Monson, Brian Bruce 

Human Subject Studies 

Study# Study Title Clinical Trial? 

Auditory experience during the prenatal and perinatal period No 

Funding Opportunity Number: PAR-18-487 Received Date: Tracking Number: GRANT12962231 2019-10-28T12:08:58.000-04:00 Page 56 
Contact PD/PI: Monson, Brian Bruce 

Section 1 - Basic Information (Study 1) 

1.1. Study Title * 

OMB Number: 0925-0001 and 0925-0002

Expiration Date: 03/31/2020

Auditory experience during the prenatal and perinatal period 

1.2. Is this study exempt from Federal 

Regulations * 

1.3. Exemption Number 

❍ Yes 

❏ 1 ❏ 2 

● No 

❏ 3 ❏ 4 ❏ 5 ❏ 6 ❏ 7 ❏ 8 

1.4. Clinical Trial Questionnaire * 

1.4.a. Does the study involve human participants? ● Yes ❍ No 

1.4.b. Are the participants prospectively assigned to an intervention? ❍ Yes ● No 

1.4.c. Is the study designed to evaluate the effect of the intervention on the 

participants? 

1.4.d. Is the effect that will be evaluated a health-related biomedical or 

behavioral outcome? 

1.5. Provide the ClinicalTrials.gov Identifier (e.g. 

NCT87654321) for this trial, if applicable 

❍ 

❍ 

Yes 

Yes 

● No 

● No 

Funding Opportunity Number: PAR-18-487 Received Date: Tracking Number: GRANT12962231 2019-10-28T12:08:58.000-04:00 Page 57 
Contact PD/PI: Monson, Brian Bruce 

Section 2 - Study Population Characteristics (Study 1) 

2.1. Conditions or Focus of Study

❍ Premature birth

2.2. Eligibility Criteria

Preterm infants:

- birth less than 32 weeks gestational age

- no known or suspected congenital anomaly

- no congenital infection (e.g., syphilis, HIV, TORCH)

- no known prenatal brain lesion (e.g., cysts or infarctions)

Pregnant women:

- greater than 18 years of age

- permanent residents of Champaign or Illinois

- less than 32 weeks pregnant

- no history of mental disease, drug abuse, or other chronic health conditions

- no current complications in pregnancy

2.3. Age Limits Min Age: N/A (No limit) Max Age: N/A (No limit)

2.4. Inclusion of Women, Minorities, and Children Inclusion_of_women_minorities_children.pdf

2.5. Recruitment and Retention Plan Recruitment_and_retention_plan.pdf

2.6. Recruitment Status Recruiting

2.7. Study Timeline Study_timeline.pdf

2.8. Enrollment of First Subject 10/03/2018 Actual

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INCLUSION OF WOMEN AND MINORITIES 

Very preterm infants

Based on the demographics of the Champaign-Urbana area (American Indian-0.3%; Asian-8.9%; Black-12.4%; 

Native Hawaiian-0.1%; White-73.4%; Hispanic Ethnicity–5.3%; Not Hispanic or Latino-94.7%), which is the 

anticipated distribution of preterm infants, the planned enrollment is as shown in the Planned Enrollment table. 

We will make every effort to seek out participants from ethnic and racial groups who are admitted to the Carle 

neonatal intensive care unit (NICU). After identifying suitable families of eligible preterm infants admitted to the 

NICU, Carle research staff will approach and invite the family to participate in the proposed experiment. The 

initial approach will detail the nature and duration of the experiment, any potential benefits and risks, as well 

as their rights as study participants. Given the admission rates at the Carle NICU (>120 very preterm infants 

annually), we believe we will be able to recruit a subject pool based on the planned enrollment. We expect no 

difficulty in recruiting male and female subjects in equal numbers. 

Pregnant women and full-term infants 

Based on the demographics of the Champaign-Urbana area (American Indian-0.3%; Asian-8.9%; Black-12.4%; 

Native Hawaiian-0.1%; White-73.4%; Hispanic Ethnicity–5.3%; Not Hispanic or Latino-94.7%), which is the 

anticipated distribution of pregnant women, the planned enrollment is as shown in the Planned Enrollment 

table. We will make every effort to seek out participants from ethnic and racial groups. We will post flyers in 

maternity clinics, schools, and libraries located throughout the Champaign-Urbana area, including public 

schools and clinics/libraries located in low-income neighborhoods. After identifying suitable subjects, the initial 

visit will detail the nature and duration of the experiment, any potential benefits and risks, as well as their rights 

as study participants. 

INCLUSION OF CHILDREN 

Very preterm infants

Children will be included in this group. We include infants born less than 32 weeks’ gestation because risks for 

cognitive deficits and other adverse health outcomes drop substantially for infants born after this gestational 

age. On our investigative team we have a neonatologist and a neuroscientist with training and clinical research 

experience with preterm infants. We also have a pediatric audiologist collecting audiological data. Thus we 

bring substantial expertise for working with children of this age. 

Pregnant women and full-term infants 

Children will be included in this group as we will collect audiological data on the full-term born infants of our 

pregnant female subjects. These full-term infants will serve as a control group for our preterm infant population. 

Pregnant children (i.e., pregnant females age 18 and under) will not be included in pregnant women group. We 

exclude pregnant children in this case because of the added emotional strain and unique social consequences 

of teen pregnancy, which would likely affect the pregnant child’s social behavior and willingness and/or ability 

to complete the study. 

Inclusion of Women, Minorities, and Children Page 59 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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RECRUITMENT AND RETENTION PLAN 

Very preterm infants

Families of infants who meet the eligibility criteria will initially be identified by the attending neonatologist or 

nurse at Carle Hospital, who will discuss the study with the family and then refer the family to the clinical 

research coordinator or research nurse practitioner at Carle Hospital. The coordinator or nurse practitioner, 

along with University of Illinois research staff, will provide further information about the study and obtain 

informed consent from families interested in participating. For retention, research staff will periodically followup with families to assess their satisfaction with study participation. A small care package consisting of child 

toys, a book, thank-you card, etc., will be provided to each family after discharge who completes the NICU 

portion of the study. Families will be reminded after discharge of the 3-month follow up visit to the audiology 

clinic. 

Pregnant women and full-term infants 

Participants will be recruited through word-of-mouth and via public postings, media, and the Internet. Flyers 

will be posted in maternity clinics, schools, and libraries located throughout the Champaign-Urbana area. 

Potential participants will initiate contact with research team members if interested in participating in the study. 

During the initial contact, the research team member will provide further information about the study, assess 

eligibility, and schedule a meeting to obtain informed consent for eligible women interested in participating. For 

retention, research staff will periodically follow-up with subjects to assess their satisfaction with study 

participation. Subject remuneration may increase slightly after four weeks of participation to facilitate retention. 

A small care package consisting of child toys, a book, thank-you card, etc., will be provided to each mother 

after delivery who completes the pregnancy portion of the study. Along with the care package, mothers will be 

provided a reminder of the 3-month follow up visit to the audiology clinic. 

Recruitment and Retention Plan Page 60 
Contact PD/Pl: Monson, Brian Bruce 

Year1 Year 2 Year3 

01 102 03 104 01 102 103 104 01 02 103 04 

VPT Beg n recru tment and data co ect on (N = 50; 8- to Data co ecton (N = 50) Group 12-week data co ecton perod per subject) 

Pregnant Beg n recru tment and data co ect on (N = 50; 8- to Data co ect on (N = 50) Group 12-week data co ecton perod per subject) 

ABR data co ecton at 52 weeks postmenstrua age (i.e., 3 months corrected age) 

I Aud tory exposure data 

anayss (Am 1) 

ABR anayss (Ams 2 & 3) 

Manuscr pt preparat on and subm ss on 

R01 proposa preparat on and 

submsson 

Study Timeline Page 61 
Contact PD/PI: Monson, Brian Bruce 

Inclusion Enrollment Reports 

IER ID# Enrollment Location Type Enrollment Location

Study 1, IER 1 Domestic Champaign-Urbana, Illinois

Study 1, IER 2 Domestic Champaign-Urbana, Illinois

Study 1, IER 3 Domestic Champaign-Urbana, Illinois

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Inclusion Enrollment Report 1 

Using an Existing Dataset or Resource* : ❍ Yes 

Enrollment Location Type* : ● Domestic 

Enrollment Country(ies): USA: UNITED STATES

Enrollment Location(s): Champaign-Urbana, Illinois

Comments: Very preterm infant group

● 

❍ 

No 

Foreign 

Planned 

Racial Categories 

Ethnic Categories 

Not Hispanic or Latino 

Female Male 

Hispanic or Latino 

Female Male 

Total 

American Indian/ 

Alaska Native 1 1 0 0 2 

Asian 5 5 0 0 10 

Native Hawaiian or 

Other Pacific Islander 1 1 0 0 2 

Black or African 

American 6 6 0 0 12 

White 34 34 3 3 74 

More than One Race 0 0 0 0 0 

Total 47 47 3 3 100 

Cumulative (Actual) 

Racial Categories Not Hispanic or Latino

American Indian/ 

Alaska Native 

Asian 

Native Hawaiian or 

Other Pacific Islander 

Black or African 

American 

White 

More than One Race 

Unknown or 

Not Reported 

Total 

Ethnic Categories 

Unknown/Not 

Hispanic or Latino Reported Ethnicity 

Unknown/ 

Female Male Not Female Male 

Reported 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 

Unknown/ 

Not 

Reported 

0 

0 

0 

0 

0 

0 

0 

0 

Total 

Female 

0 

0 

0 

0 

5 

0 

0 

5 

Male 

0 

0 

0 

0 

4 

0 

0 

4 

Unknown/ 

Not 

Reported 

0 

0 

0 

0 

0 

0 

0 

0 

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0 

0 

0 

9 

0 

0 

9 
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Inclusion Enrollment Report 2 

Using an Existing Dataset or Resource* : ❍ Yes 

Enrollment Location Type* : ● Domestic 

Enrollment Country(ies): USA: UNITED STATES

Enrollment Location(s): Champaign-Urbana, Illinois

Comments: Pregnant women

● 

❍ 

No 

Foreign 

Planned 

Racial Categories 

Ethnic Categories 

Not Hispanic or Latino 

Female Male 

Hispanic or Latino 

Female Male 

Total 

American Indian/ 

Alaska Native 2 0 0 0 2 

Asian 10 0 0 0 10 

Native Hawaiian or 

Other Pacific Islander 2 0 0 0 2 

Black or African 

American 12 0 0 0 12 

White 68 0 6 0 74 

More than One Race 0 0 0 0 0 

Total 94 0 6 0 100 

Cumulative (Actual) 

Racial Categories Not Hispanic or Latino

American Indian/ 

Alaska Native 

Asian 

Native Hawaiian or 

Other Pacific Islander 

Black or African 

American 

White 

More than One Race 

Unknown or 

Not Reported 

Total 

Ethnic Categories 

Unknown/Not 

Hispanic or Latino Reported Ethnicity 

Unknown/ 

Female Male Not Female Male 

Reported 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 

0 0 0 0 0 

Unknown/ 

Not 

Reported 

0 

0 

0 

0 

0 

0 

0 

0 

Total 

Female 

1 

1 

0 

0 

9 

1 

0 

12 

Male 

0 

0 

0 

0 

0 

0 

0 

0 

Unknown/ 

Not 

Reported 

0 

0 

0 

0 

0 

0 

0 

0 

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1 

0 

0 

9 

1 

0 

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Inclusion Enrollment Report 3 

Using an Existing Dataset or Resource* : ❍ Yes 

Enrollment Location Type* : ● Domestic 

Enrollment Country(ies): USA: UNITED STATES

● No 

❍ Foreign 

Enrollment Location(s): Champaign-Urbana, Illinois

Comments: Full-term infants (birthed by our pregnant women group)

Planned 

Racial Categories 

Ethnic Categories 

Not Hispanic or Latino 

Female Male 

Hispanic or Latino 

Female Male 

Total 

American Indian/ 

Alaska Native 1 1 0 0 2 

Asian 5 5 0 0 10 

Native Hawaiian or 

Other Pacific Islander 1 1 0 0 2 

Black or African 

American 6 6 0 0 12 

White 34 34 0 0 68 

More than One Race 0 0 0 0 0 

Total 47 47 0 0 94 

Cumulative (Actual) 

Racial Categories 

American Indian/ 

Alaska Native 

Asian 

Native Hawaiian or 

Other Pacific Islander 

Black or African 

American 

White 

More than One Race 

Unknown or 

Not Reported 

Total 

Not Hispanic or Latino 

Ethnic Categories 

Unknown/Not 

Hispanic or Latino Reported Ethnicity

Unknown/ 

Female Male Not 

Reported 

0 0 0 

0 0 0 

0 0 0 

0 0 0 

0 0 0 

0 0 0 

0 0 0 

0 0 0 

Total 

Unknown/ 

Female Male Not 

Reported 

0 0 0 

0 0 0 

0 0 0 

0 0 0 

0 0 0 

0 0 0 

0 0 0 

0 0 0 

Female 

0 

0 

0 

0 

5 

0 

0 

5 

Male 

1 

1 

0 

0 

4 

1 

0 

7 

Unknown/ 

Not 

Reported 

0 

0 

0 

0 

0 

0 

0 

0 

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1 

0 

0 

9 

1 

0 

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Section 3 - Protection and Monitoring Plans (Study 1) 

3.1. Protection of Human Subjects Protection_of_human_subjects.pdf

3.2. Is this a multi-site study that will use the same protocol to ❍ Yes ● No ❍ N/A 

conduct non-exempt human subjects research at more than one

domestic site?

If yes, describe the single IRB plan 

3.3. Data and Safety Monitoring Plan

3.4. Will a Data and Safety Monitoring Board be appointed for ❍ Yes ● No 

this study?

3.5. Overall structure of the study team

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PROTECTION OF HUMAN SUBJECTS 

1. Risks to Human Subjects

1a. Human Subjects Involvement, Characteristics, and Design 

The proposed study is a prospective observational cohort study examining (1) the effect of premature birth on 

perinatal auditory exposures and auditory neurodevelopment, and (2) the effect of neonatal intensive care unit 

(NICU) auditory exposures on infant auditory function. The study population will consist of infants born very 

preterm (VPT; <32 week’s gestation) because risks for cognitive deficits and other adverse health outcomes 

decrease substantially for infants born after 32 weeks gestational age. The control group will consist of pregnant 

women and their fetuses that will ultimately be born full-term. Our power analysis indicates we need a sample 

size of 69 per group to detect anticipated effect sizes. The target enrollment is 100 VPT infants and 100 

pregnant women/full-term infants because we expect some attrition (e.g., pregnant women who ultimately 

undergo premature labor). 

The VPT infant group will be recruited from the Carle Foundation Hospital NICU under the supervision of CoInvestigator Derrick Rollo, MD, attending neonatologist, and Principle Investigator Brian Monson, PhD. NICU 

auditory exposure data collection will take place in the Carle NICU. The pregnant women will be recruited from 

the Champaign-Urbana community under the direction of Dr. Monson. Audiological assessments will take place 

at the University of Illinois at Urbana-Champaign (UIUC) Audiology Clinic at 52 weeks postmenstrual age (age 

3 months for the full-term infant group, and 3 months corrected age for the VPT infant group), under the 

supervision of our Clinical Pediatric Audiologist Brittney Reidy, AuD, and Dr. Monson. 

1b. Study Procedures, Materials, and Potential Risks

Auditory exposure data will be collected from all participants using small, wearable audio recording devices, 

called LENA devices. LENA devices will be placed inside the incubator or crib for NICU infants. The devices 

will be worn around the neck for pregnant women. Audio recordings will be made in this process. Additionally, 

medical histories, medical factors related to birth and delivery, and social factors will be collected from medical 

records and/or via questionnaires. Audiological data will be collected at 52 weeks postmenstrual age using 

standard pediatric audiological assessments. 

For preterm infants, LENA devices will be sanitized prior to placement inside the incubator/crib using standard 

sanitizing procedures for NICU electronic equipment. Because audio recordings will be made, personal health 

information and private conversations may be recorded. To minimize risks of confidentiality, all audio data will 

be stored on HIPAA-compliant encrypted password-protected servers. Each participant will be given an ID 

number and all data will be recorded using only that ID number. Only those researchers involved in the project 

with proper human subjects and ethics training will have access to the data. Any hard copies of identifiable 

data will be stored in a locked cabinet in a locked office. 

2. Adequacy of Protection Against Risk

2a. Informed Consent and Assent 

VPT Infant Group 

Parents of eligible VPT infant patients will be approached by their physician or nurse at the Carle Hospital NICU 

to inform them of the study. They will then be approached by the Carle Hospital clinical research coordinator 

or nurse practitioner to provide further information. Informed consent will be obtained by the clinical research 

coordinator or nurse practitioner for parents agreeing to participate in the study. 

All participants will be fully informed of the purpose of and methods used in each experiment. The experimental 

protocol and informed consent procedure will be overseen by the local institutional review board (IRB) on the 

use of human subjects at the Carle Hospital. Participants will be encouraged to discuss any comments, 

criticisms or difficulties with the PI, Co-I, or research staff. Participants will be informed of PI’s role and are 

encouraged to contact the PI in the event that they are dissatisfied by their treatment in any manner. All 

participants will be informed that they may withdraw from the study at any time, for any reason. 

Pregnant Women/Full-term Infant Group 

Potential pregnant women participants will initiate contact with the UIUC research team after learning of the 

study via advertisement or word of mouth. After assessing eligibility, an initial meeting will be scheduled with a 

Protection of Human Subjects Page 67 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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member of the UIUC research team to provide further information. Informed consent will be obtained by a 

member of the research team. 

All subjects will be fully informed of the purpose of and methods used in each experiment. The experimental 

protocol and informed consent procedure will be overseen by the local IRB on the use of human subjects at 

UIUC. Subjects will be encouraged to discuss any comments, criticisms or difficulties with the PI or research 

staff. Subjects will be informed of PI’s role and are encouraged to contact the PI in the event that they are 

dissatisfied by their treatment in any manner. All subjects will be informed that they may withdraw from the 

study at any time, for any reason. 

2b. Protection Against Risk

The data collection procedures, including LENA devices and audiological assessments, represent minimal risk 

to the participants in this study. For preterm infants, LENA devices will be sanitized prior to placement inside 

the incubator/crib using standard sanitizing procedures for NICU electronic equipment. Based on our pilot data 

and previous studies conducted by others, the LENA device poses little to no risk of interference with medical 

procedures in the NICU. However, because audio recordings will be made, personal health information and 

private conversations may be recorded. To protect against risks of confidentiality, analysis of audio recordings 

will consist of automated procedures that require no listening to the audio recordings. To further protect against 

risks of confidentiality, all audio data will be stored on HIPAA-compliant encrypted password-protected servers. 

Each participant will be given an ID number and all data will be recorded using only that ID number. Only those 

researchers involved in the project with proper human subjects and ethics training will have access to the data. 

Any hard copies of identifiable data will be stored in a locked cabinet in a locked office. 

For audiological assessments, some infants may exhibit discomfort or general fussiness. Our trained pediatric 

audiologist (Dr. Reidy) will conduct and oversee audiological assessments and will be able to help soothe the 

infant and/or determine when to cease the procedure. 

2c. Vulnerable Subjects 

Pregnant Women, Fetuses, and Neonates 

This study is comprised of subjects that are pregnant women, fetuses, and neonates. 

The use of a LENA device poses no known risks specific to pregnant women or fetuses beyond those of the 

pregnant woman carrying a small device (e.g., a cell phone). 

The use of a LENA device poses no known risks specific to neonates in the NICU beyond that of routine NICU 

medical care. Although we have yet to encounter such an incident, adhering a LENA device to the inner wall 

of an incubator using Command Strips presents the possibility that the device might fall. To protect against any 

risk, research and nursing staff will be trained to adhere the device securely to the wall using an ample amount 

of Command Strip tape and place the device in a location where a potential fall is unlikely to touch the infant. 

Pediatric audiological assessments pose minimal risk to infants and are routinely conducted. We will have our 

trained pediatric audiologist conduct and oversee all audiological assessments. 

3. Potential Benefits of the Proposed Research to Research Participants and Others 

All parents whose infants undergo audiological assessments will receive a clinical diagnosis of their baby’s 

hearing. Following participation in the study, all parents who desire to know their baby’s auditory exposures 

prior to full term will be provided with this information. This information could help parents determine whether 

they wish to modify their baby’s exposures (e.g., by increasing language input). 

4. Importance of the Knowledge to be Gained 

The proposed research will greatly enhance our understanding of how prenatal and perinatal auditory 

experience affects auditory brain development and communication behavior. It will also provide critical 

information regarding how NICU auditory exposures differ from intrauterine auditory exposures, paving the way 

for interventions designed to optimize NICU auditory experience for preterm infants. 

Protection of Human Subjects Page 68 
Contact PD/PI: Monson, Brian Bruce 

Section 4 - Protocol Synopsis (Study 1) 

4.1. Brief Summary

4.2. Study Design

4.2.a. Narrative Study Description

4.2.b. Primary Purpose

4.2.c. Interventions

Type Name Description 

4.2.d. Study Phase

Is this an NIH-defined Phase III Clinical Trial? ❍ Yes ❍ No 

4.2.e. Intervention Model

4.2.f. Masking ❍ Yes ❍ No 

❏ Participant ❏ Care Provider ❏ Investigator ❏ Outcomes Assessor 

4.2.g. Allocation 

4.3. Outcome Measures

Type Name Time Frame Brief Description 

4.4. Statistical Design and Power

4.5. Subject Participation Duration

4.6. Will the study use an FDA-regulated intervention? ❍ Yes ❍ No 

4.6.a. If yes, describe the availability of Investigational

Product (IP) and Investigational New Drug (IND)/

Investigational Device Exemption (IDE) status

4.7. Dissemination Plan 

Funding Opportunity Number: PAR-18-487 Received Date: Tracking Number: GRANT12962231 2019-10-28T12:08:58.000-04:00 Page 69 
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Delayed Onset Studies 

Delayed 

Onset Study# 

Study Title Anticipated Clinical 

Trial? 

Justification 

The form does not have any delayed onset studies 

Page 70 

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Contact PD/PI: Monson, Brian Bruce 

DATA SHARING PLAN 

The unique non-identifiable resources that will stem from the experiments in this proposal include ABR 

waveforms and other deidentified clinical data, NICU and fetal auditory exposure summary data, and 

survey/questionnaire data. We will seek approval from our pregnant participants to make their audio recordings 

publicly available contributions to day-long audio recording data bases (e.g., TalkBank). Because the raw 

NICU recordings will include identifiable protected health information, these recordings may not be shared 

publicly, however summary data and acoustic measures obtained from these recordings will be made publicly 

available. The proposed research may result in the development of advanced acoustic analysis tools that will 

be made freely available. We have no proprietary interest in these tools and feel that they would be an asset to 

the auditory community at large. In addition, we will also provide copies of documents or samples of any 

materials developed under this award. In summary, any and all non-identifiable resources developed through 

this NIH-funded project will be made readily available for research purposes to qualified individuals within the 

scientific community. 

1 Resource Sharing Plan(s) Page 79