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SUMMARY STATEMENT 

PROGRAM CONTACT: ( Privileged Communication ) Release Date: 03/19/2020 

Revised Date: 

Application Number: 1 R21 DC017820-01A1 

Principal Investigator 

MONSON, BRIAN BRUCE 

Applicant Organization: UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN 

Review Group: CDRC 

Communication Disorders Review Committee 

Meeting Date: 02/20/2020 RFAIPA: PAR18-487 

Council: MAY 2020 PCC: HROS 

Requested Start: 07/01/2020 

Project Title: Auditory experience during the prenatal and perinatal period 

SRG Action: Impact Score:20 

Next Steps: Visit https://grants.nih.gov/grants/next_steps.htm 

Human Subjects: 30-Human subjects involved - Certified, no SRG concerns 

Animal Subjects: 10-No live vertebrate animals involved for competing appl. 

Gender: 1A-Both genders, scientifically acceptable 

Minority: 1A-Minorities and non-minorities, scientifically acceptable 

Age: 1A-Children, Adults, Older Adults, scientifically acceptable 

Project Direct Costs Estimated 

Year Requested Total Cost 

1 

2 

3 

TOTAL 

ADMINISTRATIVE BUDGET NOTE: The budget shown is the requested budget and has not been adjusted 

to reflect any recommendations made by reviewers. If an award is planned, the costs will be calculated by 

Institute grants management staff based on the recommendations outlined below in the COMMITTEE 

BUDGET RECOMMENDATIONS section. 
 

 

 

 

 

 

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MONSON, B 

1R21DC017820-01A1 Monson, Brian 

RESUME AND SUMMARY OF DISCUSSION: This resubmitted application for an NIDCD Early 

Career Research (ECR) Award (R21) (PAR 18-487) seeks three years of support for Dr. Monson to 

study the effect of premature birth on auditory neurodevelopment and communication behavior. The 

project proposes to examine the acoustic environment, especially the language environment, of 

preterm infants exposed to the acoustic input of the neonatal intensive care unit (NICU) versus third 

trimester in utero infants, and to correlate this with vocalizations and auditory brainstem response. The 

project is significant and innovative, and has high potential for medical impact for improving therapeutic 

and prevention strategies in pre-term children who develop auditory processing problems. Strengths of 

the application include the PI, who has strong publication record and the requisite expertise in electrical 

engineering and speech-hearing science, as well as experience with preterm infants, a collaborative 

team which provides additional expertise, and an environment that has sufficient resources and 

infrastructure for the research activities. The approach is innovative, preliminary data support feasibility 

and the device (LENA system) provides powerful assessment of auditory and language environments 

and will be used to record acoustic environments for preterm and term infants. Previous concerns about 

variabilities of LENA devices due to factors such as heartbeat, mother’s voice, interference from 

respiratory cannulas, and unusual or weak vocalizations have been addressed, and a consultant has 

been added to help with LENA, vocal and communication development studies. Overall enthusiasm for 

this project is high, reviewers discussed some less significant issues in the research plan, and note 

additional consideration should be given for alternate strategies, if the LENA system does not provide 

sufficient information. 

DESCRIPTION (provided by applicant): Within the United States alone, over a half-million infants are 

born premature each year. While medical advances have dramatically improved survival rates, longterm 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. 

PUBLIC HEALTH RELEVANCE: 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, 
 

 

 

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medical care, and sounds in the neonatal intensive care unit affect brain development in preterm 

infants. 

CRITIQUE 1 

Significance: 1 

Investigator(s): 1 

Innovation: 2 

Approach: 3 

Environment: 1 

Overall Impact: This is a resubmission of a project investigating how the acoustic environment of 

preterm infants in the NICU compares to that of the third trimester in utero acoustic environment. 

Experiments investigate how these environmental differences correlate with hearing in premature and 

full-term infants using auditory brainstem responses (ABR). The project is novel and of high 

importance, since most studies of the developmental effects of different acoustic environments have 

been restricted to animal models. The data have the potential to influence early intervention strategies 

to mitigate auditory and language developmental delays in children born prematurely. The productive PI 

is well-suited to carry out the proposed research with his broad training and expertise. Institutional 

commitment is clear, and adequate resources are available to the PI in his own laboratory and 

department. The resubmitted experimental plan is more focused and well-considered. Previous 

concerns about using the LENA system in the characterization of the acoustic environment and sources 

of sounds in utero have mostly been addressed, but there remain some weaknesses in the 

consideration and analysis of the many factors to be measured. The collaborating team should be able 

to help troubleshoot any remaining issues. The project, if successful, is likely to produce data that can 

be used for a competitive R01 application. 

1. Significance: 

Strengths 

• Animal studies have identified numerous deleterious effects of abnormal acoustic experience on 

auditory development, but it is uncertain how these findings translate to humans. This is not a 

simple thing to test in humans; therefore, the proposed research represents an important step in 

understanding how different acoustic experience (prenatally or in the NICU) affects auditory 

development in humans. 

• There is a substantial literature documenting the increased sound levels in NICUs, but our 

understanding of how exposure to these sounds affects infants’ auditory development compared 

to infants with typical in utero acoustic experience is limited. The proposed research takes an 

important step in understanding this relationship. 

• Given the increased prevalence of auditory and language disorders in preterm infants, the 

research has obvious importance for informing interventions to prevent or ameliorate these 

disorders. 

Weaknesses 

• None noted by the reviewer 

2. Investigator(s): 

Strengths 

• The PI has a solid publication record and a record of funding, with several publications that are 

directly relevant to the proposed research. 

• The PI’s multidisciplinary training and experience in engineering, speech & hearing, and 

pediatrics uniquely positions him to perform the proposed research. 
 

 

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• The Co-Is and collaborators enhance the breadth of expertise, including neonatology, clinical 

auditory physiology, audiology, speech language pathology, and biostatistics. 

Weaknesses 

• None noted by the reviewer 

3. Innovation: 

Strengths 

• The primary innovation in the proposed research lies mainly in the effort to translate knowledge 

from studies of the effects of abnormal acoustic exposures on auditory development in animal 

models. This is not a trivial task, given the logistical difficulties of assessing acoustic experience 

over time in human infants. 

• The experiments will provide important information about the diagnostic potential of using higher 

frequency tone-burst ABRs in infants. 

Weaknesses 

• The methodology is not especially novel, other than the more comprehensive assessments to 

be gleaned relative to other studies. However, this minor weakness does not dampen 

enthusiasm for the proposed work. 

4. Approach: 

Strengths 

• Measurements in Aim 1 are based on preliminary results that establish feasibility and the 

existing literature. 24-hr recordings using the LENA device will be compared 3x per week in very 

preterm infants’ incubators and cribs in the NICU or near the abdomen of the mother for full 

term infants in utero. Circadian patterns will be tracked, which is critical since the patterns of 

acoustic input or silence over time are likely to be important in addition to the overall levels and 

frequencies of the experienced sounds. 

• Diagnostic ABRs (Aim 2) will be performed at later ages to identify auditory pathway 

developmental delays. Language exposure (Aim 3) will be related to the ABR assessments of 

auditory pathway status. This is a logical progression of assessments. 

• A ‘uterine’ filer based on mean values reported in the literature will be applied to the in utero 

sound measurements to better approximate what the fetus is exposed to. 

• Input from other sensory modalities (somatosensory, visual), medical factors, and maternal 

demographics will be tracked along with auditory input in NICU patients, which will help 

determine the contribution of overall abnormal sensory input to auditory development. 

• Large sample sizes will ensure adequate statistical power. 

• The experiments are considered to be an important starting point for addressing the effects of 

auditory experience in preterm infants. 

• Most of the potential limitations are addressed. 

Weaknesses 

• Due to the nature of the study, the observed relationships between acoustic experience and 

auditory development can only be correlational. However, this is a minor weakness at this point 

in the research program and one that is inherent to this type of human work. Future studies may 

get at causality, for instance, by randomly assigning participants to different intervention 

conditions that are developed based on the results of the proposed studies. 

• Limitations of the study are considered somewhat, but alternative approaches to using the 

LENA are not really provided in Experiment 1A. What seems to be missing is validation that the 

LENA provides an accurate classification of the sounds in the noisy NICU environment 

(although the possibility of doing this is mentioned in Experiment 1B). This concern is somewhat 

mitigated by the inclusion of a collaborator with extensive experience with the LENA devices 

and should be easily addressable. 

• Aim 3 does not include plans to look at possible differences in interpeak ABR latencies due to a 

lack of effect in preliminary data. However, including this additional analysis in the larger sample 
 

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might provide information and provide important information about the conduction time along the 

pathway. It is also unclear how the individual wave latency differences are related to amplitude 

differences. 

• A more developed plan for testing the multiple co-variates that may contribute to the abnormal 

ABR latencies is needed. Presumably the collaborating biostatistician can assist with this issue. 

5. Environment: 

Strengths 

• The UIUC provides a rich intellectual environment with specialized support for junior faculty. The 

PI interacts with several other hearing and speech researchers on a routine basis. 

• Adequate research and clinical facilities are available to the PI. 

• Substantial support services are available. 

Weaknesses 

• None noted. None noted by the reviewer 

Study Timeline: Not Applicable 

Protections for Human Subjects: Acceptable Risks and/or Adequate Protections 

• Risks are minimal and adequate protections are in place. 

Inclusion Plans: 

• Sex/Gender: Distribution justified scientifically 

• Race/Ethnicity: Distribution justified scientifically 

• Inclusion/Exclusion Based on Age: Distribution justified scientifically 

• Since this is a study of infants and pregnant mothers, age and sex distributions are justified. 

Vertebrate Animals: Not Applicable 

Biohazards: Not Applicable 

Resubmission: 

• The application is mostly responsive to previous critiques. 

Select Agents: Not Applicable 

Resource Sharing Plans: Acceptable 

Authentication of Key Biological and/or Chemical Resources: Not Applicable 

Budget and Period of Support: Recommend as Requested 

CRITIQUE 2 

Significance: 2 

Investigator(s): 2 

Innovation: 2 

Approach: 2 

Environment: 2 

Overall Impact: Preterm infants have high prevalence of hearing loss, auditory neuropathy and central 

auditory processing disorders. Even without hearing loss, they have higher rates of cognitive and 
 

 

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language disorders. As pointed out by previous reviewers, this is a highly significant and understudied 

area. This application is well written by a promising investigator to evaluate the level of auditory input of 

preterm infants in the NICU (Aim1), term pregnancy is used as controls; and assess how auditory 

development (ABR at 3mo) is affected (Aim2); and compare auditory experience and short-term 

communication behavior. PI is productive, uniquely trained, and has very high potential working with a 

strong team with complementary skillsets. Strong pilot data supports feasibility and the applicant has 

properly addressed previous concerns. 

1. Significance: 

Strengths 

• Over 0.5 million preterm infants born per year, with high rates of hearing loss, auditory 

neuropathy and central auditory processing disorders 

• Sound level and quality of sound exposure to NICU children has not been systematically studied 

Weaknesses 

• None noted by the reviewer 

2. Investigator(s): 

Strengths 

• Dr. Monson is an Assistant Professor since 2017. Uniquely trained in pediatric newborn 

medicine and neuroscience. 

• Very productive publication record, another one recently added in Jan 2020. 

• Dr. Rollo (pediatrician) will help recruit patients. Brown to help with ABRs. Dr. Ambrose is an 

expert in vocal development. Danielle-Baird to assist with audiologic assessment. Dr. Shen with 

Statistics. 

Weaknesses 

• None noted by the reviewer 

3. Innovation: 

Strengths 

• Open question on the level and quality of sounds in preterm infants in comparison to term 

infants 

Weaknesses 

• None noted by the reviewer 

4. Approach: 

Strengths 

• NICU sound exposures-both levels and qualities measured 

• prelim data showing higher level of sounds and lower exposure to language-related sounds, and 

periods of silence. 

• Aim 1 VPT (very pre-term) will receive 24hr audio recording devices (LENA). Likewise, for 

pregnant mothers several times per week. 

• Aim 2-ABR at 52 weeks for both VPT and FT infants and latency tone bursts will be assessed. 

• Aim 3-relationship between auditory exposure and auditory development analyzed 

• Excellent power analyses done 

• Medical factors considered, including exposure to ototoxic medications 

Weaknesses 

• Correlation but not causative, but proposed modifying sound exposure 

5. Environment: 

Strengths 

• UIUC has a record of communication research and supportive. 

• Equipped with biostatistics support. PI has lab space and office. 
 

 

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• Access to NICU and audiology clinic in Carle Foundation Hospital (<5min) 

Weaknesses 

• None noted by the reviewer 

Study Timeline: Not Applicable 

Protections for Human Subjects: Acceptable Risks and/or Adequate Protections 

• Minimal risks to participants 

Inclusion Plans: 

• Sex/Gender: Distribution justified scientifically 

• Race/Ethnicity: Distribution justified scientifically 

• Inclusion/Exclusion Based on Age: Distribution justified scientifically 

Vertebrate Animals: Not Applicable 

Biohazards: Not Applicable 

Resubmission: 

• Previous concerns about heartbeat and digestive sounds are now considered. 

• Another previous concern that LENA will not pick up mother's voice, interference from 

respiratory cannulas, and unusual or weak vocalizations might not be picked up. So, transfer 

function is now used to account for attenuation and filtering of sound between the environment 

outside of the mother and the fetus' ears 

• One additional consultant on LENA, infant vocal and communication development 

Select Agents: Not Applicable 

Resource Sharing Plans: Acceptable 

Authentication of Key Biological and/or Chemical Resources: Not Applicable 

Budget and Period of Support: Recommend as Requested 

CRITIQUE 3 

Significance: 2 

Investigator(s): 2 

Innovation: 2 

Approach: 2 

Environment: 2 

Overall Impact: This is a resubmitted application that addresses many of the critical comments 

pertaining to the scientific approach, primarily. The topic of science is important and the approach is 

hypothetically driven. The tools (LENA) and approach are innovative and the results obtained have the 

potential to impact medical services. 

1. Significance: 

Strengths 
 

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• The contribution of noise exposure to infant development is a significant issue that is often 

overlooked. More research is needed in this area but it is a difficult population to test in a difficult 

environment. This research proposal is technically sophisticated and well thought out. 

Weaknesses 

• None noted by the reviewer 

2. Investigator(s): 

Strengths 

• The PI is well trained and well suited for this particular set of experiments. Few people in the 

world have the background to carry out this type of investigation. They have assembled a strong 

team of collaborators for additional support as needed. 

• The PI is highly productive. 

Weaknesses 

• None noted by the reviewer 

3. Innovation: 

Strengths 

• This is an important problem with relatively little research being done in this area. 

Weaknesses 

• None noted by the reviewer 

4. Approach: 

Strengths 

• This is a difficult population to test, housed in a difficult environment. Therefore, the power 

analysis and acknowledgement of the vulnerable population is a strength, as is the recognition 

of limitations and preparation for alternative approaches. 

Weaknesses 

• None noted by the reviewer 

5. Environment: 

Strengths 

• Suitable to conduct this research 

Weaknesses 

• None noted by the reviewer 

Study Timeline: Not Applicable 

Protections for Human Subjects: Acceptable Risks and/or Adequate Protections 

Inclusion Plans: 

• Sex/Gender: Distribution justified scientifically 

• Race/Ethnicity: Distribution justified scientifically 

• Inclusion/Exclusion Based on Age: Distribution justified scientifically 

Vertebrate Animals: Not Applicable 

Biohazards: Not Applicable 

Resubmission: 

• Previous review concerns addressed appropriately 

Select Agents: Not Applicable 
 

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Resource Sharing Plans: Acceptable 

Authentication of Key Biological and/or Chemical Resources: Not Applicable 

Budget and Period of Support: Recommend as Requested 

THE FOLLOWING SECTIONS WERE PREPARED BY THE SCIENTIFIC REVIEW OFFICER TO 

SUMMARIZE THE OUTCOME OF DISCUSSIONS OF THE REVIEW COMMITTEE ON THE 

FOLLOWING ISSUES: 

PROTECTION OF HUMAN SUBJECTS: ACCEPTABLE 

The protocol features minimal risk to subjects and employs adequate protection against risks. 

INCLUSION OF WOMEN PLAN: ACCEPTABLE 

The study population is expected to include equal numbers of male and female subjects, which is 

scientifically acceptable. A Targeted/Planned Enrollment Table is included and reflects this gender 

breakdown. 

INCLUSION OF MINORITIES PLAN: ACCEPTABLE 

The study population is expected to include participants from various racial/ethnic groups; this is 

scientifically acceptable. A Targeted/Planned Enrollment Table is included and reflects this racial/ethnic 

breakdown. 

INCLUSION ACROSS THE LIFESPAN PLAN: ACCEPTABLE 

The study is expected to include very pre-term infants (birth less than 32 weeks gestational age), fullterm infants, and pregnant women (greater than 18 years of age). A justification is provided, which is 

scientifically acceptable. 

VERTEBRATE ANIMAL: Not Applicable 

BIOHAZARDS: Not Applicable 

SELECT AGENTS: Not Applicable 

RESOURCE SHARING PLANS: ACCEPTABLE 

Plan for disseminating research results and sharing any relevant data with the scientific and clinical 

communities is provided. 

AUTHENTICATION OF KEY BIOLOGICAL AND/OR CHEMICAL RESOURCES: Not Applicable 

COMMITTEE BUDGET RECOMMENDATIONS: The budget was recommended as requested 

Footnotes for 1 R21 DC017820-01A1; PI Name: Monson, Brian Bruce 

NIH has modified its policy regarding the receipt of resubmissions (amended applications).See 

Guide Notice NOT-OD-18-197 at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-
 

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197.html. The impact/priority score is calculated after discussion of an application by

averaging the overall scores (1-9) given by all voting reviewers on the committee and

multiplying by 10. The criterion scores are submitted prior to the meeting by the individual

reviewers assigned to an application, and are not discussed specifically at the review meeting

or calculated into the overall impact score. Some applications also receive a percentile

ranking. For details on the review process, see

http://grants.nih.gov/grants/peer_review_process.htm#scoring.
MEETING ROSTER 

Communication Disorders Review Committee 

NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS 

CDRC 

02/20/2020 - 02/21/2020 

Notice of NIH Policy to All Applicants: Meeting rosters are provided for information purposes only. Applicant 

investigators and institutional officials must not communicate directly with study section members about an 

application before or after the review. Failure to observe this policy will create a serious breach of integrity 

in the peer review process, and may lead to actions outlined in NOT-OD-14-073 at 

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-073.html and NOT-OD-15-106 at 

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-106.htrnl, including removal of the application from 

immediate review.