Osteopathic Manipulative Treatment(OMT) for the Management of Feeding Dysfunction in Breastfed Newborns
Phase: NA
Conditions: Osteopathic Medicine, Breast Feeding
Sponsor: Methodist Medical Center of Illinois

 
 
 
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Protocol/Project Title:  
Osteopathic Manipulative Treatment (OMT) for the Management of Feeding Dysfunction in 
Breastfed Newborns 
 
 
 
 
 
Date: 
Approved 4/12/2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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Project/Protocol Review Form 
 
SECTION 1: REVIEW TYPE REQUEST 
 
Review Type (check one): 
 
☐Exempt Review -- ONLY COMPLETE BLUE SHADED SECTIONS. Research activities fall under one or more 
of the exemption categories specified by the federal regulations listed in Section 3. 
☐Expedited Review – COMPLETE ALL SECTIONS OF THIS FORM EXCEPT SECTION 3. Research activities 
fall under one or more of the expedited categories specified by the federal regulations listed in Section 4. 
☒ Full Board Review -- COMPLETE ALL SECTIONS OF THIS FORM EXCEPT SECTIONS 3 & 4. For Full 
Board Reviews, the Principal Investigator may present the protocol at the next convened IRB meeting. Please 
contact a member of the OHRO staff to set up a time at 309-680-8630. 
 
SECTION 2: INVESTIGATOR/PROJECT INFORMATION 
 
Protocol/Project Title: Osteopathic Manipulative Treatment (OMT) for the Management of Feeding 
Dysfunction in Breastfed Newborns 
 
FDA Phase Designation:  ☒NA 
☐I   ☐II   ☐III   ☐IV 
If Phase I, II, III and/or IV are checked, please ensure this research is registered at 
http://clinicaltrials.gov/  If NA, the research may still require registration with clinicaltrials.gov.  Please click 
HERE for a helpful tool or contact the IRB at 309-680-8630 for assistance.                                                                                                                
 
IND/IDE #:       
 
Sponsor:        
 
Drug Name(s):       
 
Principal Investigator Name: Dominique Fons, MD 
Department: Department of Family and 
Community Medicine  
 
Institution: University of Illinois College of Medicine at Peoria, UnityPoint Health Methodist, OSF St. 
Francis Medical Center 
 
UICOM-P Affiliation (faculty or student employee sponsor): Faculty 
 
Address: 815 Main Street, Suite B, Peoria, IL 616102 
Telephone: (309) 672-4221 
Fax:  (309) 672-4790 
 
Where will the research be taking place? 
A performance site is a location at which the research is conducted, data is gathered from subjects, 
and/or records, and/or subjects are consented into the research. 
 
☒OSF St. Francis Medical Center 
☐UICOM-P 
☒Unity Point Methodist/Proctor 
☐OSF Saint Joseph Medical Center--Bloomington 
☐Illinois CancerCare 
☐Patient Home 
☐St. Jude Midwest Affiliate 
☐Other:  (If using multiple clinics, please list  

 
 
 
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     here)        
 
 
 SECTION 3: REQUEST FOR EXEMPTION 
    
A. 
Eligibility for Exemption: 
 
1. 
Will this research involve prisoners as subjects? 
☒No – Answer must be NO for an IRB exemption. 
☐Yes - Skip to Section 5. Research involving prisoners is not eligible for an IRB 
exemption. 
2. 
Is this research FDA-regulated? 
☒No 
☐Yes, but eligible for Exemption Category 6. FDA-regulated research is only eligible for 
exemption under Category 6. 
 
B. 
Eligibility as Minimal Risk Research: 
 
Does this research pose minimal risk to subjects? 
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the 
research are not greater in and of themselves than those ordinarily encountered in daily life or 
during the performance of routine physical or psychological examinations or tests. 
☒No - Skip to Section 5. Research that is greater than minimal risk is not eligible for 
an IRB exemption. 
☐Yes – Answer must be YES to be eligible for an IRB exemption. 
 
C.  
Exemption Categories: 
Please identify the exemption category or categories that apply to your research. If your 
research does NOT fit within any of the categories below, then please STOP and complete and 
submit an Initial IRB Review application. 
☐Category 1 – Check the statement(s) below which apply to this research: 
☐Research conducted in established or commonly accepted educational settings 
☐Research involves normal educational practices, such as (i) research on regular and special 
education 
instructional strategies, or (ii) research on the effectiveness of or the 
comparison among instructional 
techniques, curricula, or classroom management 
methods 
 
☐Category 2 – Check the statement(s) below which apply to this research: 
☐Research does NOT involve children as subjects when procedures include interviews, 
surveys, or observations of public behavior and the investigators participate in the activities 
being observed. 
☐Research involves the use of educational tests (cognitive, diagnostic, aptitude, achievement) 
AND/OR 
survey procedures AND/OR interview procedures AND/OR observations of public behavior. 

 
 
 
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(If this statement has been checked, please submit surveys, questionnaires, interview 
or focus group scripts, observation plans, etc. that will be used in the research) 
☐Subjects could NOT be identified directly or indirectly through their responses, codes, 
demographics, or linked to identifiers OR subjects could be identified directly or indirectly 
through their responses, demographics, or codes linked to identifiers AND any disclosure of 
their responses outside the research could not reasonably place them at risk of criminal or 
civil liability or be damaging to the subjects' financial standing, employability, reputation, or 
insurability. 
 
 
☐Category 3 – Check the statement(s) below which apply to this research: 
☐Research is NOT exempt under Category 2 above. 
☐Research involves the use of educational tests (cognitive, diagnostic, aptitude, achievement) 
AND/OR survey procedures AND/OR interview procedures AND/OR observations of public 
behavior. (If this statement has been checked, please submit surveys, questionnaires, 
interview or focus group scripts, observation plans, etc. that will be used in the 
research. 
☐Subjects are elected or appointed public officials or candidates for public office OR federal 
statute(s) 
require(s) without exception that the confidentiality of the personally identifiable information 
will be maintained throughout the research and thereafter. 
 ☐Category 4 – Check the statement(s) below which apply to this research: 
☐Research involves the collection or study of existing data, documents, records, pathological 
specimens, or diagnostic specimens. 
☐All material used to conduct the research exists at the time of IRB submission and no on-going 
OR 
prospective collection of material will occur. 
☐Sources of the data and/or material are publicly available OR information is recorded by the 
investigator in such a manner that subjects cannot be identified, directly or through identifiers 
linked to the subjects. 
 
Please submit data collection/extraction sheets and/or a list of variables or data 
elements that will be ACCESSED AND COLLECTED. 
 
☐Category 5 – Check the statement(s) below which apply to this research: 
☐The project is a research or demonstration project. 
☐The project is conducted by or subject to the approval of department or agency heads. 
☐The project is designed to study, evaluate, or otherwise examine: (i) Public benefit or service 
programs; 
(ii) procedures for obtaining benefits or services under those programs; (iii) possible 
changes in or alternatives to those programs or procedures; or (iv) possible changes in 
methods or levels of payment for benefits or services under those programs. 
☐The program(s) under study must deliver a public benefit (e.g., financial or medical benefits as 
provided 
under the Social Security Act) or service (e.g. social, supportive, or nutritional services as 
provided under the Older Americans Act). 
☐The project is conducted pursuant to specific federal statutory authority. 
☐The project has no statutory requirements for IRB review. 

 
 
 
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☐The project does not involve significant physical invasions or intrusions upon the privacy 
interests of subjects. 
☐This project has an authorization or concurrence from the funding agency (Please attach 
a copy of the authorization or concurrence). 
 
☐Category 6 – Check the statement(s) below which apply to this research: 
 
☐Research involves taste and food quality evaluation or is a consumer acceptance study. 
☐Wholesome foods without additives are consumed OR a food is consumed that contains a food 
ingredient at or below the level and for a use found to be safe OR a food is consumed that 
contains an agricultural chemical or environmental contaminant at or below the level found to 
be safe by the Food and Drug Administration or approved by the Environmental Protection 
Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.  

 
 
 
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SECTION 4: CATEGORIES OF RESEARCH THAT MAY BE REVIEWED  
THROUGH EXPEDITED PROCEDURES 
 
 
A. Eligibility for Expedited Review: 
1. 
Will this research involve prisoners as subjects? 
☐No – Answer must be NO to be eligible for expedited IRB review. 
☐Yes - Skip to Section 5. Research involving prisoners is not eligible for expedited review. 
 
2. 
Would identification of the subjects and/or their responses reasonably place them at 
risk of criminal or civil liability or be damaging to the subjects financial standing, 
employability, insurability, reputation, or be stigmatizing? 
☐No 
☐Yes - Describe protections that will be implemented so that risks related to invasion of privacy 
               and breach of confidentiality are no greater than minimal:        
3. 
Is this classified research involving human subjects? 
☐No - Answer must be NO to be reviewed by PIRB. 
☐Yes - Skip to Section 5. Research involving classified research is not eligible for 
expedited IRB review. 
B. Eligibility as Minimal Risk Research: 
Will this research be minimal risk? 
Minimal risk means that the probability and magnitude of harm or discomfort anticipated 
in the research are not greater in and of themselves than those ordinarily encountered in 
daily life or during the performance of routine physical or psychological examinations or 
tests. 
 
☒No - Skip to Section 5. Research that is greater than minimal risk is not eligible for expedited 
review.  
☐Yes – Answer must be YES to be eligible for expedited IRB review. 
 
C. Expedited Categories: 
Please identify the expedited category or categories that apply to your research. If your research does 
NOT fit within any of the categories below, then please STOP and Skip to Section 5. 
 
1. 
☐Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) 
Research on drugs for which an investigational new drug application (21 CFR Part 312) is 
not required.  (NOTE: Research on marketed drugs that significantly increases the risks or 
decreases the acceptability of the risks associated with the use of the product is not eligible 
for expedited review). (b) Research on medical devices for which (i) an investigational 
device exemption application (21CFR 812) is not required; or (ii) the medical device is 
cleared/approved for marketing and the medical device is being used in accordance with 
its cleared/approved labeling. 
2. 
☐Collection of blood samples by finger stick, heel stick, or venipuncture as 
follows: (a) from healthy, non-pregnant adults who weigh at least 110 
pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 
8 week period and collection may not occur more frequently than 2 times per 
week; or (b) from other adults and children, considering age, weight, and 
health of the subjects, the collection procedure, the amount of blood to be 
collected, and the frequency with which it will be collected. For these subjects, 

 
 
 
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the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 
week period and collection may not occur more frequently than 2 times per 
week. 
3. 
☐Prospective collection of biological specimens for research purposes by 
noninvasive means. Examples: (a) hair and nail clippings in a non-disfiguring 
manner; (b) deciduous teeth at time of exfoliation or if routine patient care 
indicates a need for extraction; (c) permanent teeth if routine patient care 
indicates a need for extraction; (d) excreta and external secretions (including 
sweat); (e) uncannulated saliva collected in an unstimulated fashion or 
stimulated by chewing gumbase   or wax or by applying a dilute citric 
solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid 
obtained at the time of rupture of the membrane prior to or during labor; (h) 
supra- and subgingival dental plaque and calculus, provided the collection 
procedure is not moreinvasive than routine prophylactic scaling of the teeth 
and the process is accomplished in accordance with acceptable prophylactic 
techniques; (i) mucosal and skin cells collected by buccal scraping or swab, 
skin swab, or mouth washings; (j) sputum collected after saline mist 
nebulization. 
4. 
☐ Collection of data through noninvasive procedures (not involving general 
anesthesia or sedation) routinely employed in clinical practice, excluding 
procedures involving X-rays or microwaves. Where medical devices are 
employed, they must be cleared/approved for marketing. (Studies intended 
to evaluate the safety and effectiveness of the medical device are not generally 
eligible for expedited review, including studies of cleared medical devices for 
new indications.) Examples: (a) physical sensors that are applied either to the 
surface of the body or at a distance and do not involve input of significant 
amounts of energy into the subject or an invasion of the subject’s privacy; (b) 
weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) 
electrocardiography, electroencephalography, thermography, detection of 
naturally occurring radioactivity, electroretinography, ultrasound, diagnostic 
infrared imaging, Doppler blood flow, and echocardiography; (e) moderate 
exercise, muscular strength testing, body composition assessment, and 
flexibility testing where appropriate given the age, weight, and health of the 
individual. 
5. 
☐ Research involving materials (data, documents, records, or specimens) that 
have been collected, or will be collected, solely for non-research purposes 
(such as for medical treatment or diagnosis). (NOTE: Some research in this 
category may be exempt from HHS regulations for the protection of human 
subjects 45CFR 46.101(b)(4). This listing refers only to research that is not 
exempt.) 
 
Please submit data collection/extraction sheets and/or a list of variables or 
data elements that will be ACCESSED AND COLLECTED. 
 
6. 
☐ Collection of data from voice, video, digital, or image recording made for 
research purposes.  
7. 
☐ Research on individual or group characteristics or behavior (including, but not 
limited to, research on perception, cognition, motivation, identity, language, 
communication, cultural beliefs or practices, and social behavior), or research 
employing survey, interview, oral history, focus group, program evaluation, 
human factors evaluation, or quality assurance methodologies. (NOTE: Some 

 
 
 
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research in this category may be exempt from the HHS regulations for the 
protection of human subjects 45CFR 46.101 (b)(2) and (b)(3). This listing 
refers only to research that is not exempt.) 
      

 
 
 
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SECTION 5: AUTHORIZED STUDY PERSONNEL 
List all AUTHORIZED STUDY PERSONNEL: Authorized study personnel are research personnel who are directly 
involved in conducting research with human subjects, or who are directly involved with the handling of identifiable 
private information related to those subjects, including protected health information, in the course of a research project. 
PLEASE NOTE: Authorized study personnel are required to complete CITI Human Subjects Protection Course, the CITI COI 
Mini-Course and provide a current CV or resume. The Peoria IRB recognizes CITI certifications to be valid for 3 years. To 
complete our education series, please refer to the CITI website at: https://www.citiprogram.org/ 
Name 
Degree 
Role(s) 
Date of CITI 
Training 
Completion 
Date of 
CITI COI 
Mini- 
Course 
Completio
n 
CV on File 
with IRB 
within 3 
years?  
Y or N 
Conflict of 
Interest 
Disclosure Form 
submitted with 
this study? 
Y or N 
Will this 
person be 
involved in 
the 
consenting 
process? 
Y or N 
Example: John Doe 
MD 
Principal 
Investigator 
Y 
Dominique Fons 
MD 
Principal 
Investigator 
June 5, 2017 
6/5/2017 
Y 
Y 
Y 
Kari Beth Watts 
DO 
Investigator 
07/12/2015 
07/12/2015 
Y 
Y 
Y 
Shane Rainey 
DO 
Investigator 
08/2014 
08/2014 
Y 
Y 
Y 
Holly Kapraun 
DO 
Investigator 
02/02/2016 
02/02/2016 
Y 
Y 
Y 
 Gary Knepp 
DO 
Investigator 
01/29/2017 
01/29/2017 
Y 
Y 
Y 
 Jesse Ford 
DO 
Investigator 
10/8/2017 
10/8/2017 
Y 
Y 
Y 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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 SECTION 6: RESEARCH SUMMARY 
 
Summary of Protocol: Please summarize your research protocol within 2-6 pages and submit into IRBNet. 
The research summary can be submitted as a separate document instead of within this form. Please 
submit the protocol in addition to your research summary. You must address all of the following points. 
YOUR PROPOSAL WILL BE RETURNED IF THE SUMMARY IS NOT ORGANIZED AS FOLLOWS:\ 
 
Please see Appendix A- Research Protocol for a summary of this information.  
  
1. Objectives of this project. Also include a hypothesis to be tested.  
2. Background. Provide the scientific background information with references that provide the 
rationale for the project or the device to be used. 
 
3. Study Method. Include study design (controlled, open, etc.), treatments, procedures or measurement 
on human subjects, as well as statistical methods, if appropriate. If this is a questionnaire study, include 
the instrument to be used.  If this study involves data collection, please include a data collection tool. 
 
4. Inclusion/Exclusion Criteria for  Subjects. 
Population and Sample:   
A. Estimated number of subjects:  
B. Age (inclusive)  
C. Sex (estimate M:F ratio)  
D. Describe the population from with which the sample will be drawn:  
5. Include the procedure to recruit subjects and any advertising materials:  
6. Theoretical risks and potential benefits to: (1) research subjects, (2) others:  
 
7. Alternative treatments to patients (if applicable).   
8. Describe subject compensation, including plans for prorating.   
 
SECTION 7: USE OF DRUGS, BIOLOGICS (if research does 
not involve the use of drugs or biologics, skip to Section 8) 
 
A. Use of Drugs or Biologics: 
1. Does this research involve the following test articles: 
☒None - Skip to Section 8. 
☐FDA-approved drug(s)/biologic(s) 
 
☐“Off-Label” use of an approved drug (using an FDA-approved drug for an unapproved use)  
☐Investigational (Non-FDA approved) drug(s)/biologic(s) 
 
2. Please indicate the status of the drug or biologic being used in this study: 
 
☐Use of the drug in this study is exempt from the requirements for an Investigational New Drug 
(IND) application. (Please attach a copy of the FDA Determination Letter.) 
 
☐I am seeking an exemption from the requirements for an IND. (Please complete Request for an 

 
 
 
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Exemption from the Requirement of an IND by answering the following questions.  If your trial 
does not satisfy all of the five exemption requirements above, you must submit an IND to the 
FDA prior to beginning your study.  
 
 The FDA has clearly stated that this determination should be made by the physician 
proposing the clinical investigation. 
 
a. 
The investigation is not intended to be reported to FDA as a well-controlled study in support of 
a new indication for use nor intended to be used to support any other significant change in the 
labeling for the drug 
 
☐True 
 
☐False 
 
b. If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, 
the investigation is not intended to support a significant change in the advertising for the 
product 
  
☐True 
  
☐False 
 
c. 
The investigation does not involve a route of administration or dosage level or use in a patient 
population or other factor that significantly increases the risks (or decreases the acceptability 
of the risks) associated with the use of the drug product 
  
☐True 
  
☐False 
 
d. The investigation is conducted in compliance with the requirements for review by an IRB (21 
CFR 56) and the requirements for informed consent (21 CFR 50) 
☐True 
☐False 
 
e. 
The investigation is conducted in compliance with the requirements of 21 CFR 312.7 
(Promotion and sale of investigational drugs) 
☐True 
☐False 
 
☐Use of the drug in this study requires an Investigational New Drug (IND) application. 
a. Provide IND number:       
b. Attach one of the following to allow verification of the IND number: 
IND approval letter from the FDA, IND number printed on sponsor’s protocol, OR a letter 
from the sponsor. 
 
☐The study protocol involves the use of an Investigational New Drug (IND), but the IND will not 
be administered at this study site. 
 

 
 
 
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3.  Is the manufacturer of the drug sponsoring this trial? 
☐No 
☐Yes 
 
4. Is the investigator the IND holder (sponsor)? 
☐No 
☐Yes - Attach a copy of the FDA letter approving the IND application. 
 
B. An investigator’s brochure (IB) or FDA-approved product information (package insert) must be 
submitted with this application. Please indicate which document is being submitted: 
☐Investigator’s brochure (IB): required when the drug’s status is investigational 
☐FDA-approved product information (package insert) 
 
C. Address how the study drug will be handled at each site: 
 
☐Investigational drug service (IDS) will be responsible for the storage and handling of study drug. 
☐The investigator will be responsible for the storage and handling of the study drug. 
1. Describe how disposition of the study drug will be controlled, including procedures for 
storage, dispensing, limiting access to individuals listed as study personnel on the protocol 
and accountability.       
2. Indicate where the drug will be stored.       
3. Provide a contact person at the site who can verify the institution’s approval of these procedures. 
      
 
 
 
D. Does the sponsor of this research require compliance with the ICH-GCP guidelines? 
☐No 
☐Yes 
 
 
SECTION 8: USE OF MEDICAL DEVICES (if research does 
not involve the use of medical devices, skip to Section 9) 
 
A. Use of a Medical Device: 
1.  Does this research involve any of the following Devices? 
 
☒None - Skip to Section 9. 
 
☐FDA-approved medical device 
 
 ☐“Off-Label” use of an approved medical device (using an FDA-approved medical device for an  
unapproved use) 
☐The device is a Humanitarian Use Device (HUD) 
☐The device is exempt from the requirements for an Investigational Device Exemption (IDE). (Please 
attach a copy of the FDA Determination Letter.) 
☐I am seeking an exemption from the requirements for an IDE. (Please complete Request for an Exemption 
Drug accountability records along with storage and dispensing of study drug are subject to audit. 

 
 
 
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from the Requirement of an IDE. 
☐The device is a non-significant risk device. (Please attach a copy of the FDA determination letter.) 
☐This is a significant risk device. 
a. Provide IDE number: 
b. Please attach the IDE approval letter or conditional approval from FDA to allow verification of the 
IDE number and the FDA’s risk determination. 
2. Is the manufacturer of the device sponsoring this trial? 
☐No - Indicate the sponsor :       
☐Yes 
 
 
3. Is the investigator the IDE holder (sponsor)? 
☐No 
☐Yes - Attach a copy of the FDA letter approving the IDE application. 
 
4. A device manual and/or FDA-approved product labeling must be submitted with 
this application. 
☐Device Manual 
☐FDA-approved product labeling 
 
5. Address how the study device will be handled at each site. 
☐The investigator is responsible for the storage and handling of the study device. 
a. Describe how disposition of the study device will be controlled, including procedures for 
storage, dispensing, limiting access to individuals listed as study personnel on the 
protocol and accountability.       
b. Indicate where the device will be stored.       
c. Provide a contact person at the site who can verify the institution’s approval of these 
procedures.       
 
 
 
SECTION 9: SPONSOR DATA 
 
Department of Health and Human Services (HHS) regulations at 45 CFR 46.103(f) require that each 
application or proposal for HHS-supported human subject research be reviewed and approved by the 
Institutional Review Board (IRB). 
 
The IRB's review should ensure that all research described in the application or proposal is entirely 
consistent with any corresponding protocol(s) submitted to the IRB. 
 
PLEASE NOTE: If grant funding is awarded AFTER IRB approval, the IRB must be informed of the 
change in funding status via Change in Research. 
 
Please check one of the categories below to designate funding status: 
Device accountability records along with storage and dispensing of study device are subject to audit. 

 
 
 
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☐The research specified in this protocol will not be funded. 
☐The research specified in this protocol may be funded, but no research application/proposal has been 
submitted.  UICOMP Faculty: Proposal Approval Form (PAF) Number:    
☐The research specified in this protocol is funded by a pharmaceutical/device company. 
☐The research specified in this protocol is funded through NIH 
☐IL Cancer Care/CCOP Grant (include copy of front page of grant) 
☒Other: This research is support by the Caterpillar Faculty Scholar Fellowship- part of which does supply some 
financial support. No further grants or funding will be used for this research.  
 
SECTION 10: SUBJECT POPULATIONS 
 
PRIMARY SUBJECT POPULATION(S): (Check all that apply) 
 
A. General Populations:  Your research summary should justify inclusion of any ‘vulnerable’ 
populations. Required supplements will ask for details regarding additional protections or consent 
processes that would be implemented to address the rights and welfare of vulnerable groups: 
 
☒Healthy Volunteers 
☒In-Patient Population 
☒Out-Patient Population 
☐Employees 
☐Students - Specify School: UICOMP 
☐Residents/Fellows 
☐Cognitively Impaired 
☐Non-English Speakers 
☐Other: 
 
DHHS-Regulated Vulnerable Populations 
☐None STOP - Skip to Section 11. 
☒Children (Subjects under 18 yrs. of age) 
☐Children who are “youth in care” (formerly wards of the state) 
☐Prisoners Prisoner’s Vulnerable Population (VP) Supplement must be completed 
☒Pregnant Women, Fetuses, or Neonates Pregnant Women’s Vulnerable Population (VP) Supplement 
must be completed. 
B. Children Subject Population: 
 
1. Age Range (check all that apply): 
 
☒Newborn to 2 years of age   A request for a waiver of assent is expected for the age range of newborn 
to 6 years of age (Request in Section 11).  
☐3-6 Years 
 
☐7-13 Years   Verbal assent is expected for this age range unless a waiver of assent is requested in 
Section 11.  The research should be explained to the minor in age-appropriate terms.  

 
 
 
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If the minor verbally assents, the verbal agreement must be documented in the 
patient notes by the consenting individual.   
 
 
☐14-17 Years      Written documentation of assent is expected for this age range unless a  waiver of 
assent is requested in Section 11.  The research should be explained to the minor in 
age-appropriate terms and the consent/assent form should be provided or read to 
the minor.  If the minor assents, the agreement must be documented by written 
documentation on the consent/assent form.  The consenting/assenting process 
must be documented in the patient notes by the consenting individual.  
 
2. Please identify which federally-defined category applies to this research and provide the 
appropriate rationale for the inclusion of children in the chosen research category. 
☒45 CFR 46.404 (FDA 21 CFR 50.51) 
 Research involves no greater than minimal risk to children AND 
 Adequate provisions are made for soliciting the assent of the child and the permission of 
the parent/guardian 
a. Please explain why the research involves no more than minimal risk. 
- 
OMT is extremely safe and non-invasive, as observed in a RCT by Cerritelli et al. However, as 
with any medical procedure, OMT carries some risk. Risks associated with the treatments to be 
used in this study include fatigue, headache, stiffness, tenderness, redness or mild swelling to 
the area after treatment. If treatment does not work, while patients do not appreciate any 
benefit, they also do not usually show side effects.  Patients who respond to treatment often 
begin feeling better within a day and then noticing improvement of their original symptoms (in 
this case, improved feeding).  
- 
The benefits of OMT can be numerous. Common benefits include reduction of pain, improved 
range of motion and use of a joint(s), improved flow of body fluids such as blood and lymph, 
decreased swelling, and improved balance between the sympathetic (fight or flight) and 
parasympathetic (rest and digest) nervous systems. Benefits can occur immediately after 
treatment and/or over several days to weeks after treatment.  Potential benefits of treatment 
are improved feeding which includes improved latch of the baby, improved swallow, and 
reduced pain related to feeding for both mom and baby. 
b. Please explain how assent of the child and permission of the parent/guardian will be obtained, 
and provide justification if the signature of only one parent/guardian will be solicited: 
- 
Parents will receive information about our study from the lactation specialist caring for them 
and their child in the way of our OMT Brochure entitled “Osteopathic Manipulative Treatment 
and Your Baby,” which has been included in this IRB submission 
- 
This brochure will be given to all newborn babies who appear on the lactation rounding list 
and meet criteria for admission into our study.  
- 
The nurse or lactation specialist will page a member of the research team who will then 
consent the parents.  
- 
 Once enrolled in the study, each newborn will be single blinded (to lactation) and randomized 
to either the treatment or the control group.  
- 
Signature from one parent will be obtained unless they have waived her parental rights. If the 
parent is not physically available she/he will be verbally consented.  
 

 
 
 
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☐45 CFR 46.405 (FDA 21 CFR 50.52) 
 Research involves greater than minimal risk to children BUT 
 Presents the prospect of direct benefit to the individual child AND 
 Anticipated benefit justifies the risk AND 
 Anticipated benefit versus the risk is at least as favorable as that of alternative approaches AND 
 Adequate provisions are made for soliciting the assent of the child and the permission of the 
parent/guardian 
a. Please explain why the risk is justified by the anticipated benefit to the child: 
b. Please explain why the anticipated benefit versus the risk is at least as favorable as that of 
available alternative approaches: 
c. Please explain how assent of the child and permission of the parent/guardian will be obtained, 
and provide justification if the signature of only one parent/guardian will be solicited: 
☐45 CFR 46.406 (FDA 21 CFR 50.53) 
 Research involves greater than minimal risk to children AND 
 Presents no prospect of direct benefit to the individual child BUT 
 the risk represents a minor increase over minimal risk AND 
 Interventions or procedures present experiences that are reasonably commensurate with those 
inherent in the child’s actual or expected medical, dental, psychological, social, or educational 
situations AND 
 Interventions or procedures are likely to yield generalizable knowledge about the child’s disorder 
or condition that is of vital importance for the understanding or amelioration of the child’s disorder 
or condition AND 
 Adequate provisions are made for soliciting the assent of the child and the permission of the 
parent/guardian. 
a. Explain why the risk represents a minor increase over minimal risk. 
b. Please compare the actual or expected medical, dental, psychological, social, or educational 
experiences of the child subjects with the experiences presented by the research interventions or 
procedures: 
c. Please explain why the interventions or procedures are likely to yield generalizable knowledge 
about the child’s disorder of condition that is of vital importance for the understanding or 
amelioration of the child’s disorder or condition: 
d. Please explain how assent of the child and permission of one parent will be 
Obtained. 
☐45 CFR 46.407 (FDA 21 CFR 50.54) 
 Research not otherwise approvable under one of the above categories BUT 
 Presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health 
or welfare of children AND Adequate provisions are made for soliciting the assent of the child and 
the permission of the parents. 
 
 

 
 
 
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a. Please explain why the proposed research presents an opportunity to further the 
understanding, prevention, or alleviation of a serious problem affecting the health or 
welfare of children:       
 
e. b. Please explain how assent of the child and permission of one parent will be 
obtained  
 
SECTION 11: INFORMED CONSENT/ASSENT 
 
 
Please indicate all of the types of consent processes to be used in the research, and submit copies of all 
relevant documents with this application. 
 
☐Prospective Written Informed Consent 
☐Waiver of Informed Consent 
☐Waiver of Documentation of Consent 
☐Alteration of Consent 
☒Parental Permission 
☐Waiver of Parental Permission 
☐Assent – Written for ages        
☐Assent – Verbal for ages       
☒Waiver of Assent----For our newborn population 
 
Procedures to Obtain Informed Consent 
 
Request for Waiver of Consent, Alteration of Consent, or Waiver of Documentation 
 
An IRB may (1) approve a consent process that does not include, or alters, some or all of the elements of 
informed consent, or (2) the IRB may waive the requirement to obtain written consent (called a waiver of 
documentation), or (3) the IRB may waive the requirement to obtain informed consent entirely. 
 
A. Are you requesting a waiver of informed consent or an alteration of consent under 45 CFR 46.116 (d) for all 
or part of the research? 
☒No 
☐Yes 
If YES, are you requesting a: 
☐Waiver for all of the research Skip to Section B. 
☐An alteration of consent - Skip to Sections B & C. 
☐Waiver for part of the research Which part?- Skip to Section B. 
☐Waiver of documentation of informed consent - Skip to Section D. 
 
Research in this category must be sent to a federal panel for determination before final IRB approval can be 
obtained, and the recruitment and enrollment of subjects can begin. 

 
 
 
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B. Waiver for All of the Research 
1. Please provide a written explanation as to why you believe the proposed research (or portion of the 
research) will present no more than minimal risk to the subjects who participate:       
2. Please explain whether or not a waiver or alteration of informed consent would adversely affect the 
rights and welfare of subjects:       
3. Please explain whether or not it would be possible to conduct this research without a waiver or 
alteration of informed consent:       
 
4. Please explain your plans, when appropriate, for providing any pertinent information to the subjects at a 
later date (e.g., after their participation in the study):       
 
C. Alteration of Consent 
Please describe in detail how you wish to alter the consent process and justify the need for this alteration: 
      
D. Waiver of Documentation of Informed Consent 
Please indicate which of the following justifications is being used to request a waiver of documentation and then 
provide protocol specific justification for the waiver under either criteria: 
☐The only record linking the subject and the research would be a signed consent document, the 
principal risk or harm of the research would be a breach of confidentiality, and each subject will be 
asked whether they want documentation linking themselves and the research and the subject’s wishes 
will govern.  Explanation:       
☐The research involves no more than minimal risk or harm to the subject and involves no 
procedures for which written consent is normally required outside of the research context. 
Explanation:       
 
Procedures to Obtain Assent 
A. Assent will be solicited from: 
☒All children 
☐A sub-group of children (request waiver of assent in Section B & C) 
☐None of the children (request waiver of assent in Section B & C)  
 
B. I am requesting waiver of the requirement for assent from: 
☒All children 
☐A sub-group of children (request waiver of assent) 
 
C. Indicate justification for waiving assent for these children: (Check all that apply) 
☐The intervention or prospect involved in the research holds out a prospect of direct benefit that is  
important to the health or well-being of the child/children and is available only in the context of the 
research. 
☒The children are not capable of providing assent based on the age, maturity, or psychological state. 
☐The capability of the children is so limited that they cannot reasonably be consulted. 
 
SECTION 12: HIPAA COMPLIANCE 

 
 
 
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For exempt or  
recruitment purposes 
 
A. For your research, will you ACCESS OR COLLECT Protected Health Information (PHI)? 
☐No – Skip to Section 13. 
☒Yes 
 
B.   Please indicate the authorization processes that will be used in the research. 
 
☒Waiver/Alteration of Authorization for identifying potential subjects for the recruitment phase 
A waiver/alteration is a request to forgo the authorization requirement based on the fact that the use 
and/or disclosure of PHI involves minimal risk to the subject’s privacy and the research cannot be 
practically done without this waiver/alteration and access to/use of PHI.  Complete C1 a. 
 
☐Waiver/Alteration of Authorization for MAIN research project 
Remember that if you are seeking a waiver/alteration of Authorization for other than recruitment 
purposes, you should request the parallel waiver/alteration of informed consent in your research 
protocol application submitted for initial review.  Complete C1 b.  
 
☐Patient Authorization 
A patient authorization is a document, signed by the subject that gives the researcher permission to 
use/disclose PHI collected during the research study for defined purposes. An Authorization Form may be a 
separate document or be combined with the Informed Consent Document. 
 
C. Waiver/Alteration of Authorization - Complete this section to request a waiver of authorization for 
identifying potential subjects for the recruitment phase, the entire research protocol, for a 
portion of the research, or to request an alteration of authorization process, such as no signed 
documentation. 
 
1. Describe the identifiable health information that will be used  under these waivers:  See below under 
B 
 
a. 
Partial waiver of HIPAA Authorization for screening purposes (what variables will be 
ACCESSED through a query or review to determine patient eligibility for the research?):  
b. Waiver of HIPAA Authorization for the MAIN research project (what variables will be 
COLLECTED and maintained for the research project/):  
- 
We will need access to the following PHI 
a. 
Name 
b. DOB 
c. 
Sex 
d. MRN 
e. 
Mother’s Name and DOB  
f. 
Room Number while in the hospital 
g. 
Phone number 
h. Address (street, city, state, and zip code) 
i. 
Clinic schedule for lactation 
j. 
Inpatient rounding list for lactation 
 
 
PLEASE NOTE: You will be limited to ACCESSING (1a) and COLLECTING/MAINTAINING (1b) 
the data listed here. Please ensure this list includes EVERYTHING you will need to perform 

 
 
 
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your study, (i.e. name, MRN, phone number, address, clinic schedule, etc.) 
 
2. Criteria for a Partial Waiver/Alteration of  HIPAA Authorization for screening purposes (complete if  B 
box 1 is marked above) 
a. Explain how the use and disclosure of the information presents no more than 
minimal risk to the privacy of the individual:  
b. Describe the plan to protect the identifiers from improper use and disclosure 
(i.e., where will the identifiers will be stored and who will have access):  
c. Describe the plan to destroy the identifiers at the earliest opportunity consistent 
with the conduct of the research. If there is a health or research justification for 
retaining identifiers or if such retention is required by law, please provide this 
information as well 
d. Explain why the research could not be practicably conducted without the alteration or 
waiver:  
e. Explain why the research could not be conducted without access to and use of the PHI:  
f. The Privacy Rule requires that when a waiver is granted that only the minimum necessary 
health information be ACCESSED AND COLLECTED. Therefore, provide justification that 
the PHI being requested is the minimum necessary information reasonably necessary to 
accomplish objectives of the proposed research:  
 
3. Criteria for Waiver/Alteration of HIPAA Authorization for the MAIN study (complete if B 
box 2 is marked above) 
a. Explain how the use and disclosure of the information presents no more than 
minimal risk to the privacy of the individual: This information will be used by 
the research team only to 1) identify if the newborn qualifies for admission 
into the study, 2) identify the correct patient prior to beginning treatment.  
b. Describe the plan to protect the identifiers from improper use and disclosure 
(i.e., where will the identifiers will be stored and who will have access):   The 
information will be stored in a password protected document that will be 
only available to the researchers on the team, all of whom has undergone CITI 
training. When possible (ie: for the statistician) the information will be de-
identified.       
c.   Describe the plan to destroy the identifiers at the earliest opportunity 
consistent with the conduct of the research. If there is a health or research 
justification for retaining identifiers or if such retention is required by law, 
please provide this information as well:    All PHI will be held for the duration 
of the study so that if there are any adverse outcomes we can see if the 
participant was in the control vs. treatment group. This data will be held as 
long as deemed necessary by UnityPoint Health and/or OSF St. Francis 
Medical Center.  
d.  Explain why the research could not be practicably conducted without the 
alteration or waiver:   Without this PHI we can not 1) identify if the newborn 
qualifies for admission into the study, 2) identify the correct patient prior to 
beginning treatment. 
e.  Explain why the research could not be conducted without access to and use of 
the PHI:  Without this PHI we can not 1) identify if the newborn qualifies for 
admission into the study, 2) identify the correct patient prior to beginning 

 
 
 
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treatment. 
f.   The Privacy Rule requires that when a waiver is granted that only the 
minimum necessary health information be ACCESSED AND COLLECTED. 
Therefore, provide justification that the PHI being requested is the minimum 
necessary information reasonably necessary to accomplish objectives of the 
proposed research:  We require this PHI so that our research team can:  1) 
identify if the newborn qualifies for admission into the study, 2) identify the 
correct patient prior to beginning treatment. 
 
 
SECTION 13: RESEARCH RECORDS 
 
1. Indicate the source(s) from which data will be collected: 
☐Data containing no health information  (Skip to Section 14). 
☒Physician/Clinic Records 
☐Lab, Pathology and/or Radiology Results 
☐Biological Samples 
☐Interviews/Questionnaires 
☐Photographs 
☐Internet Research Data 
☒Hospital/Medical Records (in and outpatient) 
☐Mental health records 
☐Psychotherapy notes* 
☒Data previously collected for research purposes 
☐Audio/Video Recordings 
☐Billing Records 
☐School Records 
☐Information related to drug abuse, alcoholism or alcohol, testing for or infection with human 
immunodeficiency virus (HIV)* 
☐Other: Describe:       
 
*Please contact the IRB for assistance.  This information is considered “sensitive information.”  Any 
sensitive information collected for this study may be more protected than other information collected 
for this study.  For this reason, you may be asked to sign additional forms if multiple disclosures of the 
sensitive information are needed. 
 
2. Indicate the identifiable elements that will be collected: 
 
☒ Names 
☐ Social Security Numbers 
☐ Device Identifiers/Serial Numbers 
☒ Phone Numbers 
☒ Medical Record Numbers 
☐ Web URLs 
☒ Street Address 
☐ Health Plan Numbers 
☐ IP Address Numbers 
☒ City or State 
☐ Account Numbers 
☐ Biometric 
☒ Zip Code 
☐ Fax Numbers 
☐ Vehicle ID Numbers 
☐ E-mail Address 
☐ License/Certificate Numbers 
☐ Facial Photos/Images 
☐ Financial Account Information (including student ID) 

 
 
 
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☐ All Elements of Dates (except year) for dates directly related to an individual; and all ages over 89 and all 
elements of dates (including year) indicative of such age 
☒Date of Birth 
☐Any Other Unique Identifier – Specify:       
☐None of the Identifiers Listed Above 
 
*If social security numbers will be collected, explain why they are necessary and how will they be used: 
**Biometric identifiers are observable biological characteristics which could be used to identify an 
individual (i.e., fingerprints, iris/retina patterns, and facial patterns). 
 
3. Will any identifiable data, or coded data, where a master list to the codes exist, be retained for 
future studies or entered into an existing databank as a result of the research? 
☒No – Please skip to Question 4 
☐Yes - If YES, complete a-k. 
 
a. Describe what data will be retained or entered into an existing databank.       
b. Will identifiable or coded data from children/minors be retained for future research or entered into an 
existing database? 
☐No 
☐Yes - Please describe the procedures for soliciting consent from subjects that “age-up” to use their 
identifiable or coded data for future studies or to retain in an existing databank.  Please provide an 
“age of majority” consent.         
 
c. Will the information collected and stored with the data include individually identifiable 
health information subject to the HIPAA Privacy Rule requirements (45 CFR Parts 160 
and 164)? 
☐No 
☐Yes - If YES, please describe the protections in place to maintain confidentiality and prevent an 
inadvertent breach of confidentiality. 
 
d. Describe the purpose of retaining/banking the data?       
 
e. Will any information/results of this research be shared with the subjects during or after the 
current research is completed? 
☐No 
☐Yes - If YES, please explain:       
 
f. Please indicate which risks of participation are present with the retention or banking of data 
(mark all that apply): 
 
☐Identification 
☐Inadvertent or inappropriate use of individually identifiable information (breach of confidentiality) 
☐Freedom of Information Act (data becomes a government record) 
☐Law enforcement access (Example: genetic information may be used to link a subject, or a 
family member, to a crime) 
☐Risks to specific groups, populations, communities (Example: redlining neighborhoods at risk 
for lead poisoning) 
☐Risks related to return of research results (Example: subject misunderstanding of the clinical 

 
 
 
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importance of results in relation to individual cases) 
 
g. Where and for how long with the specimens be stored?       
 
h. Will the principal investigator “own”/be custodian of the data? 
☐No - If NO, please explain who will “own”/be custodian of the data:       
☐Yes 
 
i. Will data be shared with others internal to your institution? 
☐No 
☐Yes - If YES, explain how and with whom data will be shared, and if the data will include 
codes or identifiers (i.e., describe the mechanism for sharing):       
 
j. Will data be shared with investigators outside your institution? 
☐No 
☐Yes - If YES, explain how and with whom data will be shared, and if the data will include 
codes or identifiers (i.e., describe the mechanism for sharing):       
 
k. Has all of the above information been included in the consent document (i.e., purpose, type of 
information stored, identifiability, for how long, share information back, re-consent for future 
research uses, confidentiality safeguards, risks related to potential breach of confidentiality, etc.)? 
☐No 
☐Yes 
4. Will any specimens be stored for the current or future (planned or unplanned) research? 
☒No – Please skip to Section 14 
☐Yes - If YES, complete a-l. 
a. Describe the specimen(s).  
b. Will specimens from children/minors be banked for current or future research? 
☐No 
☐Yes – Please describe the procedures for soliciting consent from subjects that “age-up” during the  
course of the current study or for future studies.  Please provide an “age of majority” consent.  
      
 
c. Will the information collected and stored with the data include individually identifiable 
health information subject to the HIPAA Privacy Rule requirements (45 CFR Parts 160 
and 164)? 
☐No 
☐Yes - If YES, please describe the protections in place to maintain confidentiality and prevent an 
inadvertent breach of confidentiality.       
d. Describe the purpose of storing the specimen(s)?       
e. Will any information/results of this research be shared with the subjects during or after the 
current research is completed? 
☐No 
☐Yes - Please explain:       
 

 
 
 
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f. Please indicate which risks of participation are present with the specimen storage (mark all that 
apply):  
 
☐Identification 
☐Inadvertent or inappropriate use of individually identifiable information (breach of confidentiality) 
☐Freedom of Information Act (data becomes a government record) 
☐Law enforcement access (Example: genetic information may be used to link a subject, or a family 
member, to a crime) 
☐Risks to specific groups, populations, communities (Example: redlining neighborhoods at risk for 
lead poisoning) 
☐Risks related to return of research results (Example: subject misunderstanding of the clinical 
importance of results in relation to individual cases) 
 
g. Where and for how long with the specimens be stored?       
 
h. Will the specimen(s) be destroyed after the current research purpose is served?  
☐No - If NO, how will the specimen(s) be stored after use in the current research is completed 
(i.e., no identifiers, indirect identifiers, or direct identifiers)? 
☐Yes 
i. Will the principal investigator “own”/be custodian of the specimen(s)? 
☐No - If NO, please explain who will “own”/be custodian of the specimen(s): 
☐Yes 
j. Will specimen(s) be shared with other investigators internal to your institution? 
☐No 
☐Yes - If YES, explain how and with whom specimen(s) will be shared, and if the specimen(s)  
will include codes or identifiers (i.e., describe the mechanism for sharing):       
 
k. 
Will specimen(s) be shared with investigators outside your institution? 
☐No 
☐Yes - If YES, explain how and with whom specimen(s) will be shared, and if the specimen(s) will 
include codes or identifiers (i.e., describe the mechanism for sharing):       
l. 
Has all of the above information been included in the consent document (i.e. purpose, type of 
information stored, identifiability, for how long, share information back, re-consent for future 
research uses, confidentiality safeguards, risks related to potential breach of confidentiality, etc.)? 
☐No 
☐Yes 
 
SECTION 14: DATA SECURITY PLAN 
PLEASE NOTE:  Flash drives, or any laptops, portable hard drives, flash drives, USB memory sticks, smart 
phones, mp3 players, or similar portable storage devices, must be encrypted.  For encryption software 
applications other than those supported by the UI Health System, the investigator must provide the IRB with 
documentation confirming the software’s compliance with the HITECH Act standards.  
 
1. Outline the process for data collection (Paper or electronic medical records, paper forms completed at a site, 

 
 
 
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local electronic data capture systems or central web based systems, etc.)  
- 
Data collection will occur through accessing the patients’ chart to obtain LATCH 
scores throughout the study. This will be done through computers and laptops that 
have been encrypted through UnityPoint Health and/or OSF St. Francis Medical 
Center- no personal laptops will be used.  
- 
Paper documentation will be held in a LOCKED cabinet in the PI office and will be 
scanned into the chart after 2 weeks. Once it is scanned into the chart, the paper copy 
will be destroyed.       
2. How will data be collected from source documents and incorporated into the research record (paper case 
report forms, eCRFs, patient diary, eDiary, patient monitoring device, etc.)  
- 
Data will only be pulled from EPIC and only the patients’ LATCH score will be 
recorded.  
3. Describe the methods of storage of data (i.e., electronic, hard copy, specimens, artifacts, etc.)  
- 
A secure database of those enrolled in the study, which arm of the study they are 
enrolled, and their de-identified number will be stored in REDCap or Qualtrics or similar 
database 
- 
Data collection will occur through accessing the patients’ chart to obtain LATCH 
scores throughout the study. This will be done through computers and laptops that 
have been encrypted through UnityPoint Health and/or OSF St. Francis Medical 
Center - no personal laptops will be used.  
- 
Paper documentation will be held in a LOCKED cabinet in the PI office and will be 
scanned into the chart after 2 weeks. Once it is scanned into the chart, the paper copy 
will be destroyed. 
4. Describe where each method of data will be stored and how each method will be maintained in a 
secured manner (i.e., encryption, password protection, use of Qualtrics or REDCap, etc.)  
- 
A secure database of those enrolled in the study, which arm of the study they are 
enrolled, and their de-identified number will be stored in REDCap or Qualtrics or similar 
database 
- 
Paper documentation will be held in a LOCKED cabinet in the PI office and will be 
scanned into the chart after 2 weeks. Once it is scanned into the chart, the paper copy 
will be destroyed. 
- 
REDCap or Qualtrics or similar database will be used for data compilation. Members of 
the research team will have access 
- 
Statistician will have access to de-identified data.  
5. Describe who will have access to each method of data and how each method of data will be transferred to any 
collaborators.  
- 
The medical students and attendings that are CITI certified and are members of the 
research team will have access to: 
o 
REDCap or Qualtrics or similar database 
o 
EPIC chart 
o 
Paper documentation 
o 
They will see PHI and will not be blinded 
- 
The medical students and attendings who are not CITI certified OR are not members 
of the research team will be have access to: 
o 
EPIC chart, when appropriate for direct patient care 
o 
Will document in the paper chart and then will hand over the information to the 
research team.  
o 
May request access to the paper documentation 
- 
Support staff for this research project, including but not limited to the statistician will 
have access to:  
o 
REDCap or Qualtrics or similar database to help compile data 

 
 
 
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6. Describe the plans for destruction/removal of identifiers. (Identifiers should be removed at the earliest 
opportunity.) (If you requested a partial waiver of HIPAA Authorization for screening purposes in 
Section 12 by marking Box 1, please mark OTHER and explain that identifiers will be destroyed 
after data collection.) 
 
☒End of study 
☐       Years after study completion 
☐Other (specify)       
Consider the following when answering item 6: 
 The consent document must describe if or when and how the data will be de-identified or 
destroyed, or if identifiers will be maintained. 
 Investigator must adhere to sponsor requirements or procedures outlined in the grant, if 
applicable. 
 If the research involves a waiver of authorization, to conform to the HIPAA regulations 
accounting requirements related to a waiver of authorization [Privacy Rule, 45 CFR Part 164]; 
please indicate that records (including the documentation of waiver approval) will be 
maintained for a minimum of 6 years following study completion. 
 
SECTION 15: SUBJECT RECRUITMENT 
 
1. How will potential subjects be initially identified for this research study? 
 
☒PI/collaborators will recruit their own patients (face to face) 
 
☒Advertisements/media. All material must have IRB approval. See attached 
 
☐Registry or bank (either  pecimens or 
data) Is it an IRB-approved registry? 
☐No 
☐Yes - If YES, IRBNet #:        
      
☐Query of records (e.g.: medical, employment, school)(You MUST request a partial waiver of HIPAA 
Authorization for screening purposes in Section 12, B box 1 by completing C1a and C2.) 
 
☒Patient schedules (e.g. clinic, surgery, admission) (You MUST request a partial waiver of HIPAA 
Authorization for screening purposes in Section 12, B box 1 by completing C1a and C2.) 
- 
We will use lactation outpatient schedule and lactation’s rounding list for recruitment.  
 
☐Other (specify):       
2. Initial Contact 
Indicate who will make the initial contact with the potential subjects for the purpose of 
recruiting them for the research. 
 

 
 
 
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☒Principal Investigator 
☒Co-Investigators 
☒Other Authorized Study Personnel 
 
Newborns that are on the lactation rounding list and that meet criteria of our study will be given this 
brochure and offered admission into the study by the nurse or the lactation specialist caring for the 
newborn. If the parent is interested in participation in the study, the nurse or lactation specialist will page 
a member of the research team who will then consent the parent. 
 
 
3. Describe how, where, and when subjects will be recruited for the research 
Newborns that are on the lactation rounding list and that meet criteria of our study will be given this 
brochure and offered admission into the study by the nurse or the lactation specialist caring for the 
newborn. If parent is interested in participation in the study, the nurse or lactation specialist will put in a 
consult to the OMT and page a member of the research team who will then consent the parent.. All 
subjects will be recruited from UnityPoint Health Methodist and/or OSF St. Francis Medical Center 
4. Will any identifiable data obtained at recruitment, including screening data from records, be 
retained without consent from subjects who failed to qualify or declined to participate? 
☒No 
☐Yes - Describe and justify:        
 
SECTION 16: PRECAUTIONS AND SAFEGUARDS 
 
1. If there is a reasonable possibility that in the course of the research, it may come to the attention 
of the investigator or research team that a subject is having suicidal thoughts, please provide a 
description of how the investigator will handle this.  ☒NA 
 
 
 
2. Please describe any provisions for providing medical care to subjects in case of an accident, injury, 
or complications related to the research procedures.  ☐NA 
- 
Risk to the newborn from receiving OMT is minimal.  
- 
The attendings providing care to the newborns all have newborn admitting 
privileges and would be expected to either provide emergent care immediately 
themselves or call for assistance. 
- 
UnityPoint Health Methodist and/or OSF St. Francis Medical Center has onsite 24/7 
neonatology specialists as well.  
 
3. Is the language explaining provisions for medical care in the consent document? 
☐No 
☒Yes 
4.  Will there be a data safety monitoring board (DSMB)/ Data Monitoring Committee (DMC) assigned to this 
study? 
NOTE: If the research does not involve physical or therapeutic intervention with subjects, or 
subject trauma or distress is not an anticipated risk, this portion of the consent 
document/application may not be applicable. 

 
 
 
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☒No - If NO, skip to Question 5. 
☐If YES, describe the DSMB/DMC structure and meeting plan (for example: how often they will meet) and 
how the findings will be reported back to the individual investigators and the IRBs.       
 
5.  Does the research protocol have a data and safety monitoring plan? 
☐Not Applicable.  All of the following criteria are met: research is minimal risk, does not involve 
physical or therapeutic intervention with subjects, subject trauma or distress is not an 
anticipated risk and the sponsor does not require a monitoring plan. 
☒No - If NO, please describe the methods to be used in this study to monitor the ongoing safety of the 
subjects (please refer to the paragraph below for information to be provided.) 
☐Yes - If YES, please describe the data safety monitoring plan in detail here:       
 
Data and safety monitoring plan should contain the following: safety information (including serious 
adverse events) to be collected, methods for collecting information (e.g., case report forms, at study visits, 
by telephone calls), frequency of data collection, frequency of cumulative safety data reviews, 
responsibility for oversight and reporting of safety data, if applicable, statistical tests for analyzing the 
safety data to determine if harm is occurring when not using DSMB and, if applicable, conditions that 
trigger an immediate suspension of the Research. 
- 
Built in to our protocol is a way for any practitioner who is involved in the direct patient 
care of any of our subjects to reach out to the research team to request documentation 
of the procedures performed. This would reveal if the subject was in the control or 
treatment arm.  
- 
Any inquiry of this sort will be further investigated by the research team, including but 
not limited to: 
o 
Inquiring about adverse reaction 
o 
Determining if the participant was in the control or treatment arm 
o 
Further investigation as deemed necessary if the participant was in the 
treatment arm 
- 
Because there is a paucity of research in this area, all report adverse reactions will be 
taken seriously and investigated 
- 
Hazard ratios will be assessed  
 
6.  Is this a multi-center trial? 
☐No 
☒Yes 
 
7.  Is your site the lead site or serving as the data coordinating center? 
☐No-----NA 
☐Yes - If YES, describe the plan for managing and communicating the following information among the 
multi-center sites: 
 Unanticipated problems involving risks to subjects or others-The PI is available 24/7 for discussion of 
any unanticipated outcomes. The PI is responsible for communicating all outcomes to the IRB. 
 Interim results-Reported yearly as part of scholarly work. 
 Protocol modifications-The PI sends out updates to the research team when any updates occur to the 
protocol.  This has been clarified through meetings and emails with the research team. 
 
8.  Will you be applying for a Certificate of Confidentiality? 
☒No 

 
 
 
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☐No - Certificate already in place. 
☐Yes - If YES, please include this information (as well as any exceptions — for example: mandatory 
reporting, threats of self-harm) in the consent document. When the IRB approves your research, submit a 
request for a Certificate of Confidentiality to the appropriate federal agency. After you receive the Certificate 
of Confidentiality, you must submit an Amendment to the IRB and receive IRB approval. Research subjects 
may only be enrolled after IRB approval of the Amendment and Certificate of Confidentiality. 
 
9.  Does anything you are going to do have any effect on fetal development? 
☐Unknown 
☒No. This will be performed on newborns.  
☐Yes 
If the answer is YES or UNKNOWN, briefly describe, including a statement in the consent form for a 
woman of child-bearing potential (if she is presently pregnant or should she become pregnant) 
describing the risks involved and indicating the safeguards you will employ. 
 
10. To your knowledge, has this protocol been reviewed and subsequently disapproved by any IRB? 
☐No 
☒Yes - If YES, please provide the details of the disapproval including the reviewing IRB name, the date 
of review, the issues resulting in disapproval, and how these issues have been resolved.  When the first 
version of the protocol was submitted, clarification of the protocol and OMT techniques were necessary to 
inform the IRB about the safety of the techniques.  The IRB then TABLED WITHOUT ACTION. The PI and 
another Investigator met with the IRB and answered all questions AND a video demonstration of the 
techniques was provided.  IRB approval was obtained after this clarification. 
 
 
 
 
1.   Will subjects receive any compensation (for example: money, gifts, or gift certificates) before, during, or 
after participation in the study? 
☒No - If NO, please go to number 5. 
☐Yes ☐Monetary (total amount:      )   ☐Non- Monetary  ☐Both 
 
If YES, this information must be outlined in the consent document. 
If monetary payments total $600+/calendar year, the subjects’ social security numbers and 
addresses must be collected for IRS reporting purposes. The consent form should include this 
information. 
 
2. If compensation will be given, please describe whether it is compensation for travel expenses, for 
time, for both, or for something else: 
☐For travel expense 
☐For time 
☐For both 
☐Other:       
 
3. Indicate whether compensation will be provided in cash, via check, or as gift cards: 
☐Cash 
☐Check 
☐Gift Card – Type (VISA, Amazon, food, etc):   
SECTION 17: COMPENSATION AND COSTS OF PARTICIPATION 

 
 
 
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4.  Describe in detail how and when compensation will be provided: 
Will subjects be compensated per session/task and/or will their compensation be pro-rated? 
☐No 
☐Yes - If YES, please provide detail regarding the compensation per session/task and/or pro-ration 
schedule:       
 
5. List what research-related expenses are a) provided for free and b) not being covered by the research 
(e.g., research-related procedures, additional clinic visits, longer hospitalization period or extra tests 
related to the research). Include estimated amounts for any expenses not being covered, if possible:  
      
 
☒There will be NO expenses incurred as a research participant in this study. 
 
6. Does this study provide payments in exchange for referrals of potential participants (finder’s fees) or 
payments designed to encourage or accelerate recruitment by being tied to the rate or timing of 
enrollment (bonus payment) to individuals OR to institutions? 
☒No 
☐Yes - Please describe:        
 
SECTION 18: CONFLICT OF INTEREST 
 
Please complete the Conflict of Interest Disclosure Forms located in the IRBNet Forms Library. 
 
Non-sponsored minimal risk studies: Non-Sponsored Conflict of Interest Disclosure Form 
(NSCOIDF). The PI may submit one form on behalf of the entire research team. 
 
Sponsored research OR Non-sponsored greater than minimal risk research: Part I: Significant 
Financial Interest Disclosure Form (SCOIDF). Each Authorized Study Personnel, listed in Section 5 
of this form, must sign an individual SCOIDF. 
 
As Principal Investigator, I understand and accept responsibility for ensuring the safety and welfare of human 
subjects who participate in the proposed research study. I certify that all Authorized Study Personnel, including 
myself, co-investigators and study coordinators, have completed required training on human subjects 
protections. I agree to a continuing exchange of information with the IRB including the requirements to (i) 
obtain IRB approval before making non-emergency changes/revisions to the protocol, (ii) provide progress 
reports to the IRB at their request (and at least annually), and (iii) report promptly to the IRB all unanticipated 
problems or serious adverse events involving risk to human subjects. 
 
☒Please mark this box to certify your acknowledgement of the statements listed above. 
 
 
Please send all correspondence to: 
 
Site Name: UnityPoint Health Methodist- Family 
Medical Center 
Phone: (309) 672-4221 
Attention: Dominique Fons, MD 
Fax: (309) 672-4790 
Email: Dominique.Fons@unitypoint.org 
 
 

 
 
 
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SECTION 19: SUBMISSION CHECKLIST 
 
 
IRB Exemption: 
☐Project/Protocol Review Form 
☐Protocol summary (must follow outline in section 6 of this form) 
☐Responsibilities of Investigators Form 
☐Non-sponsored Conflict of Interest Disclosure Form (PI may complete on behalf of Authorized Study 
Personnel listed in Section 5 of this form) 
☐Any applicable advertising, grant proposals, etc. NA 
☐Current CITI certifications and current CV for all those listed in section 5 of this form, if not already 
submitted to the IRB. 
☐Any applicable questionnaires, surveys, data extraction sheets-----See Appendix for Protocol, Informed Consent, 
OMT Brochure, and Risk-Benefits and Information about OMT Handout 
 
 
Expedited Review: 
☐Project/Protocol Review Form 
☐Informed Consent (if applicable) 
☐Protocol Summary (must follow outline in section 6 of this form) 
☐Responsibilities of Investigators Form 
☐Conflict of Interest Disclosure Form (for each Authorized Study Personnel listed in Section 5 of this form) 
☐Full Protocol (if applicable) 
☐Any applicable advertising, grant proposals, etc. 
☐Current CITI certifications and current CV for all those listed in section 5 of this form, if not already 
submitted to the IRB. 
☐Any applicable questionnaires, surveys, data extraction sheets 
 
 
Full Review: 
☒Project/Protocol Review Form 
☒Informed Consent, please be sure the footer includes a version date 
☒Protocol Summary (must follow outline in section 6 of this form) 
☒Responsibilities of Investigators Form 
☒Conflict of Interest Disclosure Form (for each Authorized Study Personnel listed in Section 5 of this form) 
☒Full Protocol 
☐Investigator’s Brochure (if applicable) 
☐Device Technical Manual (if applicable) 
☒Any applicable advertising, grant proposals, etc. 
☒Current CITI certifications and current CV for all those listed in section 5 of this form, if not already 
submitted to the IRB. 
☒Any applicable questionnaires, surveys, data extraction sheet 
 
 
 

 
 
 
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Appendix A- Research Protocol 
 
Objective: The objective of this project is to see if Osteopathic Manipulative Treatment (OMT ) as an adjunct 
protocol to lactation support for infants with feeding dysfunction improves outcomes.  Null hypothesis: Term 
newborns with feeding dysfunction do not improve with the addition of OMT compared to lactation support. 
Primary Question Alternative: In term newborns with feeding dysfunction, OMT added to lactation support will 
significantly improve feeding outcomes.  
 
Background. Osteopathy, founded by Andrew Taylor Still, MD, adds manual medicine, which stresses 
the importance of structure and function, to pre-existing medical philosophy and education.  Doctors of 
Osteopathy (DOs) use Osteopathic Manipulative Treatment (OMT)  to treat somatic, or bodywork, 
dysfunction which can include one or multiple body systems, such as muscular, skeletal, arthrodial, 
vascular, lymphatic, myofascial, connective tissue, or visceral (organ). Doctors of Osteopathy use OMT to 
treat somatic dysfunction which will improve structure and in turn, improve function. There are an array 
of techniques of therapy used by DO’s, the type of treatment based on the diagnosed dysfunction, 
practioner comfort, and the needs/limitations of the patient.  
 
Nipple feeding requires a complex set of actions to coordinate suck and swallow. There is a three phase 
process including oral, pharyngeal, and esophageal phases. Effective oral and pharyngeal phases depend 
on normal function of the intrinsic muscles of the tongue as well as the extrinsic stabilizing muscles. 
Normal feeding is also dependent upon action of the Vagus, Glossopharyngeal, and Hypoglossal Nerves 
and therefore normal anatomy of the jugular and hypoglossal foramen.   
 
Research has shown there are common physiological dysfunctions/cranial strains associated with infant 
labor and delivery that may impair feeding function through abnormal structure affecting the muscles 
and/or nerves needed for normal suck and swallow function.  
 

 
 
 
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Past studies such as Dr Fraval’s 1998 pilot study on osteopathic treatment of infants with a suckling 
dysfunction have found OMT efficacious in conjunction to lactation support in infants with feeding 
dysfunction.  Other studies on OMT in newborns have found the practice to be safe, cost effective, and 
shown to decrease length of stay.  
1. Cerritelli F, Cicchitti L, Martelli M, et al. Osteopathic manipulative treatment and pain in preterms: Study protocol 
for a randomised controlled trial. Trials. 2015;16:84-015-0615-3. doi: 10.1186/s13063-015-0615-3 [doi].  
2. Cerritelli F, Martelli M, Renzetti C, Pizzolorusso G, Cozzolino V, Barlafante G. Introducing an osteopathic approach 
into neonatology ward: The NE-O model. Chiropr Man Thera. 2014;22(1). Accessed 27 September 2016. doi: 
10.1186/2045-709X-22-18.  
3. Cerritelli F, Pizzolorusso G, Ciardelli F, et al. Effect of osteopathic manipulative treatment on length of stay in a 
population of preterm infants: A randomized controlled trial. BMC Pediatr. 2013;13:65-2431-13-65. doi: 
10.1186/1471-2431-13-65 [doi].  
4. Cerritelli F, Pizzolorusso G, Renzetti C, et al. A multicenter, randomized, controlled trial of osteopathic 
manipulative treatment on preterms. PLoS One. 2015;10(5):e0127370. doi: 10.1371/journal.pone.0127370 [doi].  
5. Cerritelli F, Pizzolorusso G, Renzetti C, et al. Effectiveness of osteopathic manipulative treatment in neonatal 
intensive care units: Protocol for a multicentre randomised clinical trial. BMJ Open. 2013;3(2):10.1136/bmjopen-
2012-002187. Print 2013. doi: 10.1136/bmjopen-2012-002187 [doi].  
6. Fraval, Maxwell MPR. A Pilot study: osteopathic treatment of infants with a sucking dysfunction. Journal of the 
American Academy of Osteopathy 1998; 8(2): 25-33. 
7. Herzhaft-Le Roy et al. Efficacy of an Osteopathic Treatment Coupled With Lactation Consultations for Infants’ 
Biomechanical Sucking Difficulties: A Randomized  Controlled Trial. I Journal of Human Lactation. 1 –8. 2016 
8. Lund GC, Edwards G, Medlin B, Keller D, Beck B, Carreiro JE. Osteopathic manipulative treatment for the 
treatment of hospitalized premature infants with nipple feeding dysfunction. J Am Osteopath Assoc. 2011;111(1):44-
48. doi: 111/1/44 [pii].  
9. Martelli M, Cardinali L, Barlafante G, Pizzolorusso G, Renzetti C, Cerritelli F. Do placebo effects associated with 
sham osteopathic procedure occur in newborns? results of a randomized controlled trial. Complement Ther Med. 
2014;22(2):197-202. doi: 10.1016/j.ctim.2014.01.009 [doi].  
10. Pizzolorusso G, Cerritelli F, Accorsi A, et al. The effect of optimally timed osteopathic manipulative treatment on 
length of hospital stay in moderate and late preterm infants: Results from a RCT. Evid Based Complement Alternat 
Med. 2014;2014:243539. doi: 10.1155/2014/243539 [doi].  
11. Pizzolorusso G, Cerritelli F, D'Orazio M, et al. Osteopathic evaluation of somatic dysfunction and craniosacral 
strain pattern among preterm and term newborns. J Am Osteopath Assoc. 2013;113(6):462-467. doi: 113/6/462 
[pii].  
12. Wescott N. The use of cranial osteopathy in the treatment of infants with breast feeding problems or sucking 
dysfunction. Aust J Holist Nurs. 2004;11(1):25-32.  

 
 
 
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Study Method.  
This study is a single blinded, randomized- controlled, prospective study. The study will be conducted at 
UnityPoint Health Methodist and/or OSF St. Francis Medical Center.  
 
Enrollment and advertising: Because this research study will be open to all newborns at UnityPoint Health 
Methodist and/or OSF St. Francis Medical Center who meet inclusion criteria, this might mean that patients of 
providers who are unfamiliar with OMT are enrolled in the study. It is important to our team that all providers 
are comfortable with this research project. As such, overview of our research has been presented at the 
Pediatric and Perinatal Interdisciplinary Team Committees. Further information about the research project and 
about OMT in general has been compiled into a brochure entitled “Osteopathic Manipulative Treatment and 
Your Baby” which is included in this IRB submission. Once approved, this brochure will be sent to all Family 
Medicine, Pediatric, and Neonatology providers that admit to UnityPoint Health Methodist and/or OSF St. 
Francis Medical Center.  
 
Randomization: Newborns that are on the lactation rounding list and that meet criteria of our study will be 
given this brochure and offered admission into the study by the nurse or the lactation specialist caring for the 
newborn. If the parent is  interested in participation in the study, the nurse or lactation specialist will put in a 
consult for the OMT team and page a member of the research team who will then consent the parent.. The 
newborn will then be single blinded (to lactation) and randomized to either the treatment or control group. No 
new patients will be enrolled into the study on Fridays as our goal for all the newborns is to have at least two 
treatments before discharge and the OMT research team is only available Monday-Fridays. New enrollment will 
only occur Monday-Thursdays. Newborns that meet inclusion criteria will then be offered into the research 
study after obtaining informed consent from the parents. After listing all qualifying newborns alphabetically, 
newborns will be randomized into treatment/control groups in an alternating fashion.  
 
Protocol for Control Group: Because OMT is a manual therapy, blinding to other participants in the study 
(lactation team and parents) would be difficult without a sham protocol occurring in the control group. As such, 
our protocol for the Control Group will be evaluation of cranial strain patterns and cervical motion. These 
findings will be evaluated, documented, but no corrective treatment will be delivered.  
 
Protocol for Treatment Group: Each newborn in the treatment arm of our research group will receive the 
same OMT treatment protocol, regardless of somatic dysfunction. The benefits of using a protocol approach are: 
1) All OMT providers can be trained and achieve comfort in the treatment options, 2) Eliminates the variable of 
different treatment options being more/less effective, 3) More accurate information regarding risks/benefits 
can be communicated to parents, 4) Minimizes inter-researcher outcomes.  
The protocol was established by conducting interviews with OMT practitioners both locally and faculty at 
Osteopathic Medicine faculty at schools in different states. The finalized protocol is as follows:  
Protocol:  
1. Condylar Decompression 
2. Still Technique to Cervical Region, including the Sternocleidomastoid Muscle 
3. Balancing of the Hyoid Bone 
4. Myofascial Release of Thoracic Inlet 
 
Schedule: The OMT research team will conduct research Monday- Fridays. Newborns meeting criteria will be 

 
 
 
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enrolled on Monday-Thursdays. Treatment or sham treatment for the control group will take place Monday- 
Friday. The OMT research team will provide treatment and sham treatment to both inpatient and outpatient 
infants who are enrolled in the study. This will occur in the newborn nursery, patient room, or the lactation 
office. Residents and attending physicians will provide treatment and sham treatments, all residents will be 
directly supervised by an attending physician.  
 
Documentation: It is important to blind the lactation team to which newborns receive treatment, as it is 
lactation who will assign the L.A.T.C.H. scores. In an effort to blind the study, the OMT research team will 
document in each study participants’ chart (regardless of if they are control or treatment group) a Progress 
Note that read “This newborn is part of the Osteopathic Manipulative Treatment for the Management of Feeding 
Dysfunction in Breastfed Newborns Research Study. They may be in either the control or treatment group. 
Their documentation is available immediately by contacting the research team or by looking under Media tab in 
the next two weeks.” This will allow someone to access the information immediately if needed due to any side 
effects but also allows for blinding of the lactation team.  
 
Scoring and follow up: Infants in both control and treatment groups will have a L.A.T.C.H. assessment at 
baseline, daily during hospitalization, and at the first two outpatient lactation visits. The L.A.T.C.H. assessment 
will evaluate Latch, Audible swallow, Type of nipple (mother’s nipple), and Hold. While OMT can affect most 
components of the L.A.T.C.H. assessment, it cannot affect the mother’s type of nipple. Therefore, although the 
L.A.T.C.H. assessment will evaluate the nipple type, this data will not be used in our research. For research 
purposes the highest L.A.T.C.H. assessment score will be 8 (eight). We will collect baseline, daily assessments, 
and the two outpatient assessments which will result in 4-5 data points for each infant. These scores will be 
used to assess the benefit of the addition of OMT to the infants’ care plan for feeding dysfunction.   
 
Inclusion Criteria for Subjects.  
 
Term Infants greater than or equal to 37 weeks 
gestation 
 
Level I newborn 
 
Receiving lactation support 
 
Identified by lactation as having a newborn 
component to feeding dysfunction 
 
Admitted to UnityPoint Health Methodist hospital 
and/or OSF St. Francis Medical Center and 
available for follow up with Methodist lactation 
specialists and/or OSF St. Francis Medical Center 
lactation specialists.  
 
Available for at least 2 inpatient OMT sessions 
 
Informed Consent 
 
Exclusion Criteria for Subjects.  
 
Infants <37 weeks of gestation 
 
Level II or III newborns 
 
Infants who are wards of the state 
 
Term infants who are receiving speech therapy or 
physical therapy  
 
Infants already receiving OMT 

 
 
 
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 
Infants who are not breastfeeding 
 
Infants who have a feeding dysfunction mostly 
attributed to maternal factors (including but not 
limited to: abnormal nipples, maternal 
comorbidities, etc).  
 
Infants with Down’s Syndrome or other 
contraindications for OMT(acute infection, 
fractures, etc.). 
 
Population Sample Size:  
A. Estimated number of subjects: 78 (39 each 
group) 
A recent trial (Herzhaft-Le Roy 2016) has a significant improvement of LATCH score at the third day after 
intervention (mean=9.22, SD=0.92; mean=8.18, SD=1.60; p=0.001). Given the effect size, a power of 90% and 
a significance level of 0.05, a minimum total sample size of 70 is estimated. Considering an attrition rate of 
10%, at least 78 (39 each group) subjects are needed for this trial.  
B. Age (inclusive) - Term Infants greater than or 
equal to 37 weeks gestation.  
C. Sex (estimate M:F ratio) – We estimate a 1:1 M:F ratio 
D. Describe the population from with which the sample will be drawn- please see above information.  
 
Theoretical risks and potential benefits :  
 
OMT is extremely safe and non-invasive. The OMT technique used per the protocol are gentle and 
indirect. No direct thrusting techniques will be employed.  Investigators utilize minimal pressure during these 
techniques, so that there is no blanching of the investigator’s nailbeds. However, as with any medical procedure, 
OMT carries some risk. Risks associated with the treatments to be used in this study include fatigue, headache, 
stiffness, tenderness, redness or mild swelling to the area after treatment. If treatment does not work, while 
patients do not appreciate any benefit they also do not usually show side effects.  Patients who respond to 
treatment often begin feeling better within a day and then noticing improvement of their original symptoms (in 
this case, improved feeding). Potential benefits of treatment are improved feeding which includes improved latch 
of the baby, improved swallow, and reduced pain related to feeding for both mom and baby. 
 
 
Alternative treatments to patients (if applicable).   
 
No alternative treatments to OMT will be offered in addition to the lactation support already provided to 
breastfeeding infants and mothers who do not need a speech and/or physical therapy consult.  Our OMT will 
augment the current standard for care which includes lactation support. Infants needing a speech and/or physical 
therapy consult in addition to lactation support will be excluded from the study.   
 
Describe subject compensation, including plans for prorating.   
 
Patients will not be billed for OMT.  No monetary patient compensation will be offered 
 
 
 
 
 
Comment [RJ1]: Paper is attached. 
Comment [RJ2]: If you think there is a higher 
attrition rate, the sample size needs to be adjusted.