An Intervention to Reduce Phthalate and Bisphenol Exposure During the Critical Period of Minipuberty
Phase: NA
Conditions: Phthalate Exposure, Bisphenol Exposure
Sponsor: NYU Langone Health

Official Title: 
An Intervention to Reduce Phthalate and Bisphenol Exposure During 
the Critical Period of Minipuberty  
NCT Number:
NCT05864209
Study Number:
23-00367 
Document Type:
Study Protocol and Statistical Analysis Plan
Date of the 
Document: 
 
December 13, 2023 

Study Number: s23-00367
Version Date: 12/06/2023
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sponsor
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An intervention to reduce phthalate and bisphenol exposure during 
the critical period of minipuberty
Principal Investigator:
Linda G. Kahn, PhD, MPH
Assistant Professor, Department of Pediatrics, NYU Grossman 
School of Medicine
227 East 30th Street, Room 811, New York, NY 10016
linda.kahn@nyulangone.org
917-439-8069
NYULH Study Number:
s23-00367
Initial version:
5/2/2023
Amended: 
12/06/2023
Amended:
[date]

Study Number: s23-00367 
Version Date: 12/06/2023 
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Statement of Compliance
This study will be conducted in accordance with the Code of Federal Regulations on the Protection of Human Subjects (45 CFR Part 46), any 
other applicable US government research regulations, and institutional research policies and procedures. The Principal Investigator will assure 
that no deviation from, or changes to the protocol will take place without prior agreement from the sponsor and documented approval from the 
Institutional Review Board (IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants. All personnel involved in the 
conduct of this study have completed Human Subjects Protection Training.  
 
 

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Table of Contents 
 
PROTOCOL SUMMARY .............................................................................................................................. 6 
SCHEMATIC OF STUDY DESIGN  .............................................................................................................. 8 
KEY ROLES ................................................................................................................................................. 9 
1
INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE.....................10
1.1 
BACKGROUND INFORMATION AND RELEVANT LITERATURE ............................................................................................................................... 10 
1.2 
RATIONALE ................................................................................................................................................................................................... 11 
1.3
POTENTIAL RISKS & BENEFITS....................................................................................................................................................................... 11
1.3.1 
Known Potential Risks ............................................................................................................................................................................ 11 
1.3.2 
Known Potential Benefits ....................................................................................................................................................................... 11 
2
OBJECTIVES AND PURPOSE .........................................................................................................12
2.1 
PRIMARY OBJECTIVE ..................................................................................................................................................................................... 12 
2.2 
SECONDARY OBJECTIVES .............................................................................................................................................................................. 12 
3
STUDY DESIGN AND ENDPOINTS..................................................................................................12
3.1 
DESCRIPTION OF STUDY DESIGN ................................................................................................................................................................... 12 
3.2 
STUDY ENDPOINTS........................................................................................................................................................................................ 12 
3.2.1
Primary Study Endpoints........................................................................................................................................................................ 12
3.2.2 
Secondary Study Endpoints ................................................................................................................................................................... 12 
3.2.3
Exploratory Endpoints ............................................................................................................................................................................ 13
4 
STUDY ENROLLMENT AND WITHDRAWAL .................................................................................. 13 
4.1
INCLUSION CRITERIA ..................................................................................................................................................................................... 13
4.2
EXCLUSION CRITERIA.................................................................................................................................................................................... 13
4.3
VULNERABLE SUBJECTS................................................................................................................................................................................ 13
4.4
STRATEGIES FOR RECRUITMENT AND RETENTION........................................................................................................................................... 14
4.4.1
Use of DataCore/Epic Information for Recruitment Purposes ............................................................................................................... 15
4.5
DURATION OF STUDY PARTICIPATION............................................................................................................................................................. 15
4.6
TOTAL NUMBER OF PARTICIPANTS AND SITES................................................................................................................................................. 15
4.7
PARTICIPANT WITHDRAWAL OR TERMINATION................................................................................................................................................. 15
4.7.1
Reasons for Withdrawal or Termination................................................................................................................................................. 15
4.7.2
Handling of Participant Withdrawals or Termination .............................................................................................................................. 15
4.7.3
Premature Termination or Suspension of Study .................................................................................................................................... 15
5
BEHAVIORAL/SOCIAL INTERVENTION .........................................................................................16
5.1
STUDY INTERVENTION DESCRIPTION.............................................................................................................................................................. 16
5.1.1
Administration of Intervention................................................................................................................................................................. 16

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6
STUDY PROCEDURES AND SCHEDULE .......................................................................................16
6.1
STUDY PROCEDURES/EVALUATIONS .............................................................................................................................................................. 16
6.1.1 
Study Specific Procedures ..................................................................................................................................................................... 16 
6.1.2
Standard of Care Study Procedures ...................................................................................................................................................... 17
6.2
STUDY SPECIFIC BIOSPECIMENS.................................................................................................................................................................... 17
6.2.1 
Specimen Collection Procedures ........................................................................................................................................................... 17 
6.2.2
Specimen Preparation, Handling, and Storage...................................................................................................................................... 17
6.2.3 
Specimen Shipment ............................................................................................................................................................................... 18 
6.2.4 
Laboratory Evaluations ........................................................................................................................................................................... 18 
6.3
STUDY SCHEDULE......................................................................................................................................................................................... 18
6.3.1 
Screening ............................................................................................................................................................................................... 18 
6.3.2
Enrollment/Baseline ............................................................................................................................................................................... 18
6.3.3
Phone Call - 2 Weeks After Delivery...................................................................................................................................................... 19
6.3.4 
Phone Call - 6 Weeks After Delivery ...................................................................................................................................................... 19 
6.3.5
Study Visit............................................................................................................................................................................................... 19
6.3.6
Withdrawal Visit...................................................................................................................................................................................... 19
6.3.7 
Unscheduled Visit ................................................................................................................................................................................... 19 
7
SAFETY AND ADVERSE EVENTS...................................................................................................19
7.1
Definition of Adverse Events (AE).......................................................................................................................................................... 19
7.1.1 
Definition of Serious Adverse Events (SAE) .......................................................................................................................................... 20 
7.1.2
Definition of Unanticipated Problems (UP)............................................................................................................................................. 20
7.2
CLASSIFICATION OF AN ADVERSE EVENT........................................................................................................................................................ 20
7.2.1 
Severity of Event .................................................................................................................................................................................... 20 
7.2.2
Relationship to Study Intervention.......................................................................................................................................................... 21
7.2.3
Expectedness......................................................................................................................................................................................... 21
7.3
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP..................................................................................................... 21
7.4
REPORTING PROCEDURES – NOTIFYING THE IRB ........................................................................................................................................... 22
7.4.1
Adverse Event Reporting ....................................................................................................................................................................... 22
7.4.2
Serious Adverse Event Reporting .......................................................................................................................................................... 22
7.4.3
Unanticipated Problem Reporting .......................................................................................................................................................... 22
7.4.4
Reporting of Pregnancy.......................................................................................................................................................................... 23
7.5
REPORTING PROCEDURES – NOTIFYING THE STUDY SPONSOR ....................................................................................................................... 23
7.6
REPORTING PROCEDURES – PARTICIPATING INVESTIGATORS.......................................................................................................................... 23
8
STUDY OVERSIGHT .........................................................................................................................23
9
STATISTICAL CONSIDERATIONS ..................................................................................................24
9.1
STATISTICAL AND ANALYTICAL PLANS ............................................................................................................................................................ 24
9.2
STATISTICAL HYPOTHESES............................................................................................................................................................................ 24
9.3
ANALYSIS DATASETS..................................................................................................................................................................................... 24
9.4
DESCRIPTION OF STATISTICAL METHODS ....................................................................................................................................................... 24

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9.4.1
Analysis of the Primary Efficacy Endpoint.............................................................................................................................................. 24
9.4.2
Analysis of the Secondary Endpoints..................................................................................................................................................... 24
9.4.3 
Safety Analyses ...................................................................................................................................................................................... 24 
9.4.4
Adherence and Retention Analyses....................................................................................................................................................... 24
9.4.5
Baseline Descriptive Statistics ............................................................................................................................................................... 25
9.4.6 
Enrollment/Randomization/Masking Procedures ................................................................................................................................... 25 
9.4.7
Evaluation of Success of Blinding .......................................................................................................................................................... 25
9.4.8 
Breaking the Study Blind/Participant Code ............................................................................................................................................ 25 
10
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS.................................25
11
QUALITY ASSURANCE AND QUALITY CONTROL .......................................................................26
12 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................................. 26 
12.1
ETHICAL STANDARD...................................................................................................................................................................................... 26
12.2
INSTITUTIONAL REVIEW BOARD...................................................................................................................................................................... 26
12.3 
INFORMED CONSENT PROCESS ..................................................................................................................................................................... 27 
12.3.1
Consent and Other Informational Documents Provided to Participants................................................................................................. 27
12.3.2
Consent Procedures and Documentation .............................................................................................................................................. 27
12.4 
PARTICIPANT AND DATA CONFIDENTIALITY ..................................................................................................................................................... 28 
12.4.1
Research Use of Stored Human Specimens or Data............................................................................................................................. 29
12.5
FUTURE USE OF STORED SPECIMENS OR DATA.............................................................................................................................................. 29
13 
DATA HANDLING AND RECORD KEEPING ................................................................................... 30 
13.1
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES............................................................................................................................... 30
13.2
STUDY RECORDS RETENTION........................................................................................................................................................................ 30
13.3 
PROTOCOL DEVIATIONS ................................................................................................................................................................................ 30 
13.4
PUBLICATION AND DATA SHARING POLICY...................................................................................................................................................... 31
14
STUDY FINANCES............................................................................................................................31
14.1
FUNDING SOURCE......................................................................................................................................................................................... 31
14.2
COSTS TO THE PARTICIPANT.......................................................................................................................................................................... 31
14.3
PARTICIPANT REIMBURSEMENTS OR PAYMENTS ............................................................................................................................................. 31
15
STUDY ADMINISTRATION...............................................................................................................31
15.1
STUDY LEADERSHIP ...................................................................................................................................................................................... 31
16
CONFLICT OF INTEREST POLICY..................................................................................................32
17
REFERENCES...................................................................................................................................32
18
ATTACHMENTS ................................................................................................................................33

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List of Abbreviations
 
AE
Adverse Event/Adverse Experience
CFR
Code of Federal Regulations
CRF
Case Report Form
CSOC
Clinical Study Oversight Committee
DCC
Data Coordinating Center
DHHS
Department of Health and Human Services
DSMB
Data and Safety Monitoring Board
EDC
Endocrine-Disrupting Chemical
EMR
Medical Record Number 
FFR
Federal Financial Report
FWA
Federal wide Assurance
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act
ICF
Informed Consent Form
IRB
Institutional Review Board
LOD
Limit of Detection
ISM
Independent Safety Monitor
MOP
Manual of Procedures
MRN
Medical Record Number 
N
Number (typically refers to participants)
NIH
National Institutes of Health
NYU CHES
New York University Children’s Health and Environment Study
OHRP
Office for Human Research Protections
OHSR
Office of Human Subjects Research

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PI 
Principal Investigator
QA 
Quality Assurance 
QC
Quality Control
SAE 
Serious Adverse Event/Serious Adverse Experience 
SOP
Standard Operating Procedure
US
United States
 
 
 
 
Protocol Summary
 
Title 
An intervention to reduce phthalate and bisphenol exposure during the critical 
period of minipuberty
Short Title 
Diaper Study  
Brief Summary
Phthalates and bisphenols have been detected in a range of infant care 
products. This pilot study will test whether intervening on these sources of 
exposure during the critical period of minipuberty affects infants’ body burden 
of phthalates and bisphenols. We will recruit 10 participants from the ongoing 
NYU Children’s Health and Development Study (CHES) cohort study who are 
>=37 weeks gestation or <6 months postpartum, carrying a singleton fetus or 
with a singleton infant, and intending to breastfeed or breastfeeding. We will 
randomly assign them to use either conventional baby products or phthalate- 
and bisphenol-free baby products for the first or next three months of their 
children’s lives. Toward the end of the intervention, we will collect maternal 
breast milk and infant urine, and assay samples for phthalate metabolite and 
bisphenol concentrations. 
Phase
N/A
Objectives
Aim 1: To assess the feasibility of an intervention designed to reduce infant 
phthalate and bisphenol exposure
Aim 2 (exploratory): To compare urinary phthalate and bisphenol exposure 
levels in the intervention and non-intervention groups, as well as between 
mothers and children in the control group.
Methodology
Open-label randomized controlled trial

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Endpoint 
Participants are enrolled until they have been using the assigned diapers for 
3 months, toward the end of which time we will collect maternal breast milk 
and maternal and infant urine to test for phthalate metabolite and bisphenol 
concentrations  
Study Duration
1 year (allows for 6 months of data collection among 10 participants and 6 
months of data analysis).
Participant Duration 
3 months 
Population
We will recruit 10 participants who are already enrolled in the NYU CHES 
study at the Brooklyn campus. Eligible participants will be >=37 weeks 
gestation or <6 months postpartum, carrying a singleton fetus or with a 
singleton infant, and intending to breastfeed or breastfeeding.
Study Site
NYULH-Brooklyn
Number of participants
10 participants
Description of Study 
Intervention/Procedure 
Half of the participants will be randomly assigned to the intervention group 
and will receive a three-month supply of phthalate- and bisphenol-free baby 
products (e.g., wipes, diaper cream) and a subscription to a cloth diaper 
service.
Reference Therapy 
Half of the participants will be randomly assigned to the control group and 
provided with a three-month supply of conventional disposable diapers (e.g., 
Huggies or Pampers) and baby products (e.g., wipes, diaper cream).
Key Procedures
Three-month adherence to diaper assignment and one-time infant urine 
collection and maternal breast milk collection. 
Statistical Analysis
Our primary aim is to assess the feasibility of the intervention; the project is 
not adequately powered to detect statistically significant differences between 
groups. However, we will compare distributions of chemicals between the two 
infant groups to assess the effectiveness of the intervention and also 
between mothers and children from the control group to assess the relative 
prevalence of particular bisphenols or phthalates in diet (reflected in maternal 
breast milk concentrations) vs. baby products (reflected in infant urinary 
concentrations).

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Key Roles
 
Linda G. Kahn, PhD, MPH (Principal Investigator) 
Assistant Professor, Department of Pediatrics, NYU Grossman School of Medicine 
227 East 30th Street, Room 811, New York, NY 10016 
linda.kahn@nyulangone.org 
(917) 439-8069 
 
Leonardo Trasande, MD (Sub-Investigator) 
Pediatrics, Environmental Medicine & Population Health, NYU Grossman School of Medicine 
Director and PI of NYU CHES Study   
403 East 34th Street, 1st floor, New York, NY 10016 
leonardo.trasande@nyulangone.org 
 (646) 501-2520 
 
Sunmi Lee, MS (Sub-investigator) 
Research Scientist, Lab Manager, Department of Pediatrics, Division of Environmental Pediatrics, NYU Grossman School of Medicine 
403 East 34th Street, New York, NY 10016 
sunmi.lee@nyulangone.org 
(212) 263-1544 
(Analyze phthalate and bisphenol levels in urine and breast milk) 
 
Christian Villela Santos (Sub-Investigator) 
Research Data Associate, Department of Pediatrics, Division of Environmental Pediatrics, NYU Grossman School of Medicine 
403 East 34th Street, New York, NY 10016
areli.vicuna@nyulangone.org 
(332) 207-0725 
(Recruitment, consenting, project management, and data collection) 
 
Dimitri Abrahamsson, PhD (Study Team Member) 
Assistant Professor, Department of Pediatrics, NYU Grossman School of Medicine 
1 Park Avenue, New York, NY 10016 
Dimitrios.Abrahamsson@nyulangone.org 
(646) 745-5213 
(Assist in analysis of urine and breast milk) 
 
 

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1
Introduction, Background Information and Scientific Rationale
1.1
Background Information and Relevant Literature
 
In keeping with David Barker’s fetal programming hypothesis,1 studies of associations of phthalates and bisphenols with child health outcomes 
have focused on in utero exposure. Results have been inconclusive, however,2,3 with inconsistencies commonly attributed to varying approaches 
to exposure assessment and other methodological issues. An alternative explanation that has not been explored is the possibility that pregnancy 
may not be the only—or even the primary—critical period for early-life endocrine disruption. Minipuberty, a brief window during the first six months 
of life when sex hormones surge in sync with gonadal cell proliferation, may be a particularly vulnerable period for dysregulation of the 
hypothalamic-pituitary-gonadal axis by endocrine-disrupting chemicals (EDCs).4 Because of their estrogenic and anti-androgenic properties, 
bisphenols and phthalates have the potential to adversely affect the development of reproductive tissue responsible for sex hormone production, 
with downstream consequences for child health in multiple domains.  
 
While most conceptual models linking EDCs to reproductive health outcomes have focused on prenatal exposure, including Niels Skakkebaek’s 
Testicular Dysgenesis Syndrome theory5 and Germaine Buck-Louis’s companion Ovarian Dysgenesis Syndrome theory,6 gestation is not the only 
critical period in the development of reproductive endocrine glands. Testicular Leydig and ovarian granulosa cells undergo three phases of 
maturation, culminating in sexual maturity. The first is mid-pregnancy, when Leydig cells proliferate in the fetal testis7 and primordial follicles 
emerge in the fetal ovary.8 The second is during minipuberty, when Leydig cells undergo another burst of proliferation and differentiation, and 
granulosa cells also proliferate as part of the postnatal surge in folliculogenesis.9 Finally, both become fully activated in puberty. During 
minipuberty, reproductive hormone concentrations rise precipitously, peaking between two and three months postnatally,4 only to become 
quiescent after about six months of age until reactivated during puberty. Disruption of this intricate choreography by exposure to EDCs could have 
negative consequences for the development of a variety of tissues and organs that are regulated by sex hormones, including brain, bone, 
adipocytes, and gonads.  
 
Little research has been done on potential causes and effects of endocrine disruption during minipuberty. The only study to date to examine 
associations between EDCs and sex hormones during minipuberty reported positive associations between urinary bisphenol A (BPA) and both 
estradiol and the estradiol:testosterone ratio in the first three months of life.10 These results are consistent with BPA’s estrogenic profile; the study 
did not measure phthalates, which are more commonly anti-androgenic. Sex hormones in minipuberty, in turn, have been linked with child health 
outcomes. Nearly all of the research in this area has focused on neurodevelopment, demonstrating links between lower testosterone levels in 
male infants and compromised auditory processing and language development.11-15 Sex hormones also affect metabolism. One small study that 
examined minipuberty sex hormone levels and adipose tissue development found that testosterone and luteinizing hormone were negatively 
associated with body mass index, and estradiol was positively associated with skinfold thicknesses in boys.16
 
This pilot intervention study will assess the magnitude of infants’ exposure to bisphenols and phthalates through common infant care products. If 
research continues to show child health consequences of bisphenol and phthalate exposure during minipuberty, these products could eventually 
be targeted for regulation. 

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1.2 Rationale 
Infants are highly exposed to phthalates and bisphenols, ubiquitous EDCs that have both estrogenic and anti-androgenic activity. Phthalates and 
bisphenols have been detected in a range of infant care products, including diapers,17,18 wipes, baby lotions, soaps, shampoos,19 and plastic baby 
bottles.20 Exposure is magnified by infants’ high surface-to-volume ratio and by the increased efficiency of dermal absorption via the thin skin 
surrounding their enlarged genitalia.21 This pilot study will test whether intervening on these sources of exposure during the critical period of 
minipuberty affects infants’ body burden of phthalates and bisphenols. If successful, this protocol may be scaled up and eventually evidence may 
be used to inform regulation of chemicals contained in infant care products and educational outreach programs to protect children’s health.  
 
Aim 1: To assess the feasibility of an intervention designed to reduce infant phthalate and bisphenol exposure.  
H1: We will successfully recruit participants from within an existing cohort study and collect biosamples from participants and their children in a 
single follow-up study visit.  
 
Aim 2 (exploratory): To compare urinary phthalate metabolites and bisphenols between the intervention and non-intervention groups, as well as 
between mothers and children in the control group. 
H2: Chemical levels will be higher among infants in the control group vs. the intervention group. There will be no difference in average chemical 
concentrations between the two groups of mothers. Among controls, different chemicals will be present in breast milk vs. infant urine. 
 
1.3
Potential Risks & Benefits
1.3.1  Known Potential Risks 
There is no excess risk to participants in this study due to the intervention being tested, which is designed to reduce the risk of endocrine 
disruption. The phthalate- and bisphenol-containing disposable diapers and baby products that the control group will receive are by far the 
standard in the US. We hypothesize that the phthalate- and bisphenol-free diapers and baby products that the intervention group will receive will 
reduce their risk of health outcomes associated with EDC exposure.   
 
There is a risk of loss of confidentiality or privacy in relation to personal information and specimens to be collected upon participation in this study. 
We will make every effort to protect participants’ privacy by labeling their samples and information only with a code, and keeping the key to the 
code in a password-protected database accessible only to IRB-approved study personnel.   
 
There is no excess risk to participants associated with completing questionnaires. Participants may feel frustrated from answering questions. If 
that happens, participants are free to skip any questions they do not wish to answer.  
1.3.2 Known Potential Benefits 
Participants may gain the knowledge that they will be contributing to research that may improve our understanding of the relation between baby 
products, EDC exposure, and minipuberty.  
 

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2 
Objectives and Purpose 
2.1
Primary Objective
The primary objective of this study is to assess the feasibility of an intervention designed to reduce infant phthalate and bisphenol exposure during 
the potential critical period of minipuberty. Specifically, we aim to evaluate the feasibility of an intervention that targets EDC exposure through 
randomly assigning participants to receive conventional diapers and baby products or cloth diapers and phthalate- and bisphenol-free baby 
products from birth through age 3 months.  
2.2 Secondary Objectives  
The secondary and exploratory objective for this study is to compare urinary phthalate and bisphenol exposure levels in the intervention and non-
intervention groups, as well as between mothers and children in the control group  
 
3 
Study Design and Endpoints 
3.1 Description of Study Design 
 
This is a single-site pilot intervention study to be conducted at NYU Langone Health-Brooklyn.  
 
Participants will be recruited from the ongoing pregnancy/birth cohort study, NYU CHES study. 
 
Participants will be randomly assigned to an intervention group (N=5) or a control group (N=5).  
 
Participants will receive a 3-month supply of either disposable diapers and conventional baby products (control group) or cloth diapers 
and phthalate- and bisphenol-free baby products (intervention group) at no cost. 
 
Participants will complete brief adherence surveys at three postnatal time points.  
 
After 3 months, study personnel will conduct a study visit during which maternal breast milk and maternal and infant urine will be 
collected.  
 
Urine and breast milk samples will be analyzed for phthalate metabolites and bisphenols in the NYU Human and Environmental 
Exposure Assessment Facility Core lab. 
3.2
Study Endpoints
3.2.1 Primary Study Endpoints
The primary endpoint, needed to fulfill Aim 1, is when the total number of participants (N=10) have used their assigned baby products for three 
months and the two biospecimens (maternal breast milk and infant urine) have been collected from all participants.  
3.2.2 Secondary Study Endpoints

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The secondary endpoint, needed to fulfill Aim 2, is when the biospecimens have been analyzed for phthalate metabolites and bisphenols. 
3.2.3 Exploratory Endpoints 
 
N/A 
 
4 
Study Enrollment and Withdrawal 
4.1 Inclusion Criteria 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
 
1. Enrolled in NYU CHES study at the NYULH-Brooklyn campus 
2. Over 18 years of age 
3. At least 37 weeks gestation or <6 months postpartum 
4. Carrying singleton fetus or having given birth to a singleton infant 
5. Intending to breastfeed or breastfeeding 
6. English or Spanish speaking 
7. Intending to obtain/obtaining pediatric care for infant at the Sunset Park Family Health Center at NYU Langone 
4.2
Exclusion Criteria
An individual who meets any of the following criteria will be excluded from participation in this study:
 
1. Not enrolled in NYU CHES study from the NYULH-Brooklyn campus  
2. Under 37 weeks gestation or having had a preterm birth 
3. Carrying multiples or having given birth to multiples 
4. Not intending to breastfeed or not currently breastfeeding 
5. Not comfortable communicating in English or Spanish 
6. Not intending to obtain/obtaining pediatric care for infant at NYULH Sunset Park Family Health Center  
7. Under 18 years of age 
4.3
Vulnerable Subjects
This study includes pregnant women and neonates, who are vulnerable subjects. We do not anticipate that this study will pose greater than 
minimal risk to the mother, fetus, and later neonate, as both disposable and cloth diapers are commonly used among our study population. 
Additionally, collection of neonatal urine and maternal breast milk involves no more than minimal risk. Urine will be collected via a bag that gently 
adheres to the skin around the infant’s penis; breast milk will expressed manually by the participant. Participation in this study is entirely voluntary. 
Participants will be able to withdraw from the study at any time without negative consequences. Our study design is in compliance with all items 
included in 45 CRF part 46.204 (research involving pregnant women or fetuses) and 46.205 (research involving neonates.) Any risk to neonates is 

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expressly in pursuit of benefits that would directly benefit them; i.e. regulation of chemicals in baby products. Furthermore, while this research 
does not hold out the prospect of benefit for the pregnant woman or the fetus, risk to the fetus is not greater than minimal and the purpose of the 
research is the development of important biomedical knowledge that cannot be obtained by any other means. A pregnant person’s consent will be 
obtained in accord with the informed consent provisions of subpart A. The risk in this study is the least possible for achieving the objectives of the 
research. No inducements, monetary or otherwise, will be offered to terminate a pregnancy. Individuals engaged in the research will have no part 
in any decisions as to the timing, method, or procedures used to terminate a pregnancy. Individuals engaged in the research will have no part in 
determining the viability of a neonate.  
4.4
Strategies for Recruitment and Retention
Potentially eligible participants will be identified by Diaper Study personnel from among those already enrolled in NYU CHES study at the Brooklyn 
campus. All Diaper Study personnel will be added to the NYU CHES study. Potential participants will be recruited either by phone or at an in-
person prenatal visit at 37 weeks gestation or within 6 months postpartum.  
 
Remote Screening  
o 
Potential participants will be contacted via phone using an IRB-approved telephone recruitment script. If they are interested in 
hearing more about the study, study staff will ask screening questions over the phone to confirm eligibility.  
 
o 
If potential participants are eligible and still interested in learning more about the study, potential participants will be sent the 
REDCap link to the Key Information Sheet and Informed Consent and will be given the phone number of a study team member to 
call after they have reviewed the consent materials. Refer to Section 12.3.2 for more information on the consent procedures.  
 
o 
If potential participants are not eligible and/or do not wish to take part in the study, their PHI (phone number, address, and any 
other PHI) will be discarded at this point.  
 
 
In-Person Screening  
o 
If possible or preferred by the potential participant, screening may occur in person at the NYULH Brooklyn location. This will be 
coordinated by study staff.  
 
o 
Study staff will give the potential participant a physical copy of the Key Information Sheet and Study Infographic if it has not 
already been sent to them. If the potential participant is interested, study staff will ask screening questions to confirm eligibility.  
 
o 
If the potential participant is eligible and still interested in learning more about the study, the study staff member will walk the 
potential participant through Informed Consent. If the potential participant wishes to take part in this study, she will be asked to 
sign a paper copy of the Informed Consent. Refer to Section 12.3.2 for more information on the consent procedures.  
In order to retain enrolled participants, we will visit them in the hospital following delivery or via phone call if a birth visit is not possible in order to 
inform participants of their group assignment and contact them again two weeks and six weeks after birth to check in on the diaper delivery 
logistics and assess and encourage group assignment adherence.  

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4.4.1 Use of DataCore/Epic Information for Recruitment Purposes
 
This study will not use NYULH’s DataCore/Epic information for recruitment purposes. We will use participant information from our ongoing study 
NYU CHES study for recruitment purposes.  
4.5 Duration of Study Participation 
 
The estimated time of enrollment is 1-3 weeks prior to delivery or within 6 months postpartum. Participants and their infants will be enrolled for three 
months. 
4.6
Total Number of Participants and Sites 
10 mother-infant pairs will be enrolled in this study. It is expected that all participants will provide usable data.   
4.7
Participant Withdrawal or Termination
4.7.1 Reasons for Withdrawal or Termination
Participants are free to withdraw from the study at any time upon request and with no consequence.  
 
An investigator may terminate participation in the study if: 
 
 
Any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation occurs such that continued participation in 
the study would not be in the best interest of the participant. 
 
The participant meets an exclusion criterion (either newly developed or not previously recognized) that precludes further study 
participation. 
4.7.2
Handling of Participant Withdrawals or Termination
If a participant withdraws between the time of consent and biospecimen collection, the participant will be replaced.  
4.7.3
Premature Termination or Suspension of Study
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause. Written notification, documenting the 
reason for study suspension or termination, will be provided by the suspending or terminating party to the PI. If the study is prematurely terminated 
or suspended, the PI will promptly inform the IRB and will provide the reason(s) for the termination or suspension. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
 

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PI decision 
 
Insufficient compliance to protocol requirements  
 
Study may resume once concerns about data quality are addressed and satisfy the sponsor and/or IRB. 
 
5 
Behavioral/Social Intervention 
5.1 Study Intervention Description
 
The study intervention is supply of baby products. The intervention group (n=5) in this study will be assigned use of phthalate- and bisphenol-free 
baby products and subscription to a cloth diaper service. Participants assigned to the control group (n=5) will receive disposable diaper delivery 
and conventional baby products.  
5.1.1
Administration of Intervention
 
This intervention (supply of baby products) will be delivered via mail and/or delivery service. The frequency of delivery will depend on the delivery 
service. The delivery will cover three months’ worth of diapers and baby products.  
6 
Study Procedures and Schedule 
6.1 Study Procedures/Evaluations 
6.1.1 Study Specific Procedures
Biospecimen Collection:  
 
 
Biospecimens (1.8mL of maternal breast milk, 1.8mL of maternal urine, and 1.8 mL of infant urine) will be collected at one study visit 
approximately 2-3 months after enrollment. Biospecimen collection will occur either after a routine well-visit or at the participant’s home. If 
a home visit occurs, study staff will go to the participant’s home. Refer to Section 6.2 for more details.  
Data Collection:  
 
 
Participant’s electronic medical record will be used to monitor when they have delivered. 
 
Either the infant’s medical record or the NYU CHES study records will be used to obtain birth weight and length for analysis.  
 
NYC CHES study questionnaire data that participants previously completed under the NYU CHES study will be pulled from the NYU 
CHES study database.    

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We will create a new database for the Diaper Study where we will store all Diaper Study-related results along with demographic and NYU 
CHES study questionnaire data to be pulled from the NYU CHES database.   
 
Questionnaire Administration:  
 
 
Participants will be asked to complete a brief adherence questionnaire at three postpartum time points.  
o 
Questionnaire will be administered over the phone by study personnel 2 weeks and 6 weeks after diaper intervention has begun.  
o 
Questionnaire will also be administered during the single study visit.  
 
It will take less than 5 minutes to complete questionnaire.  
 
Questionnaire responses will be entered into REDCap by study personnel.  
 
The purpose of the questionnaire is to assess if the diaper delivery service is working smoothly for the mother and to gauge adherence to 
group assignment.   
 
Questionnaire data collected from this study will be shared with qualified researchers on the NYU CHES study. 
 
6.1.2 Standard of Care Study Procedures 
No clinical procedures are carried out in this study.  
6.2 
Study Specific Biospecimens
6.2.1 Specimen Collection Procedures  
 
Participants will be asked to manually express breast milk into a polypropylene specimen cup (Starplex Scientific Corp., Cleveland, TN).  
 
Maternal urine will be collected via standard procedure in a sterile cup.  
 
To collect infant urine, a Pediatric Urine Collector (Precision Dynamics Corp., Valencia, CA) will be provided to participants. This device is 
composed of a clear plastic bag with a foam-lined opening that adheres to the skin around the infant’s genital area without puckering, providing a 
leak-proof seal. 
Diaper Study personnel will not be involved in the maternal specimen collection procedures. Diaper Study personnel will facilitate the collection of 
infant urine.  
6.2.2
Specimen Preparation, Handling, and Storage
Urine and breast milk will be aliquoted into bisphenol- and phthalate-free 2 mL tubes (Thermo Scientific, Waltham, MA) within two hours of 
collection and will be stored at -80oC. Urine and breast milk collection containers/devices will be tested for the presence of phthalates and 
bisphenols. 

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6.2.3
Specimen Shipment
N/A 
 
6.2.4
Laboratory Evaluations
Chemical analyses. Phthalate metabolites and bisphenols will be analyzed at the NYU Human and Environmental Exposure Assessment Facility 
Core lab under the supervision of Sunmi Lee.  
 
Bisphenols. Eight bisphenols (BPA, BPAF, BPAP, BPB, BPF, BPP, BPS, and BPZ) will be determined by HPLC-ESI-MS/MS. Concentrations of 
individual bisphenols will be adjusted for creatinine (Cr) as described below. We will also sum molar concentrations of all individual bisphenols for 
a total bisphenol concentration. 
 
Phthalate metabolites. Quantitative detection of 22 phthalate metabolites will also involve HPLC-ESI-MS/MS.22 Urine samples will be processed 
using enzymatic deconjugation of glucuronidated phthalate monoesters, followed by solid phase extraction coupled with reverse-phase HPLC-ESI-
MS/MS. Individual phthalate metabolite concentrations will be adjusted for Cr as described below. We will also sum metabolites of parent 
compounds di-2-ethylhexyl phthalate (DEHP), as well as di-isononyl phthalate (DiNP) and di-n-octyl phthalate (DNOP), as DiNP, DNOP, and di-
isodecyl phthalate (DiDP, represented by its metabolite mono-carboxyl isononyl phthalate [mCINP]) are increasingly replacing DEHP in response 
to consumer advocacy and legislative activity.23
Creatinine. To account for urinary dilution, urinary Cr will be analyzed using HPLC-ESI-MS/MS as described elsewhere24 and chemical 
concentrations will be adjusted for Cr via a transformation described by Kuiper et al.,25 with an alternate adjustment method by O’Brien et al.26 and 
no adjustment explored in sensitivity analyses. 
6.3 Study Schedule 
6.3.1 Screening
 
Diaper Study personnel will identify potential participants from the NYU CHES study database.
 
Remote or in-person screening will take place. Refer to Section 4.4 for details.  
6.3.2 Enrollment/Baseline
 
Diaper Study team member will obtain consent.  
 
Diaper Study team member will assign participant to study group in alternating fashion. Participants will not be told of their group 
assignment in advance of delivery or postpartum consent.  
 
Diaper Study team member will obtain participant’s delivery date from participant’s EMR and schedule diaper delivery to their home to 
begin directly afterward or schedule diaper delivery to begin immediately if consent occurs postpartum.  

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6.3.3 Phone Call - 2 Weeks After Delivery
 
 
Diaper Study team member will confirm consent.  
 
Participants will complete questionnaire by phone. 
6.3.4 Phone Call - 6 Weeks After Delivery 
  
Diaper Study team member will confirm consent. 
 
Participants will complete questionnaire by phone. 
6.3.5 Study Visit
 
 
After using products in assigned study group for up to three months, a single study visit will occur after a routine well-visit or at 
participant’s home between 2 and 3 months after diaper intervention has begun. If visit cannot occur after infant’s well-visit, Diaper Study 
team member will go to participant’s home. 
 
Diaper Study team member will confirm consent.  
 
Participants will be asked to provide maternal breast milk and urine samples. 
 
Diaper Study team member will collect infant urine sample. 
 
Participants will complete questionnaire. 
  
6.3.6
Withdrawal Visit
 
No procedures or evaluations will be done and no biospecimens will be collected if a participant withdraws or is terminated early.  
6.3.7 Unscheduled Visit 
 
We do not anticipate unscheduled visits. 
 
 
7
Safety and Adverse Events 
7.1
Definition of Adverse Events (AE)
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study.  
Intercurrent illnesses or injuries should be regarded as adverse events.  Abnormal results of diagnostic procedures are considered to be adverse 
events if the abnormality: 
 results in study withdrawal 
 is associated with a serious adverse event 

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 is associated with clinical signs or symptoms 
 leads to additional treatment or to further diagnostic tests 
 is considered by the investigator to be of clinical significance 
7.1.1 Definition of Serious Adverse Events (SAE)
 
Serious Adverse Event 
Adverse events are classified as serious or non-serious.  A serious adverse event is any AE that is:  
 fatal 
 life-threatening 
 requires or prolongs hospital stay 
 results in persistent or significant disability or incapacity 
 a congenital anomaly or birth defect 
 an important medical event 
 
Important medical events are those that may not be immediately life threatening, but are clearly of major clinical significance. They may jeopardize 
the subject, and may require intervention to prevent one of the other serious outcomes noted above.  For example, drug overdose or abuse, a 
seizure that did not result in in-patient hospitalization, or intensive treatment of bronchospasm in an emergency department would typically be 
considered serious.  
 
All adverse events that do not meet any of the criteria for serious should be regarded as non-serious adverse events.  
7.1.2 Definition of Unanticipated Problems (UP)
 
Unanticipated Problems Involving Risk to Subjects or Others 
Any incident, experience, or outcome that meets all of the following criteria:  
Unexpected in nature, severity, or frequency (i.e. not described in study-related documents such as the IRB-approved protocol or consent 
form, the investigators brochure, etc.)
 Related or possibly related to participation in the research (i.e. possibly related means there is a reasonable possibility that the incident 
experience, or outcome may have been caused by the procedures involved in the research)
 Suggests that the research places subjects or others at greater risk of harm (including physical, psychological, economic, or social harm). 
7.2
Classification of an Adverse Event
7.2.1 Severity of Event
For AEs not included in the protocol defined grading system, the following guidelines will be used to describe severity.
 
 Mild – Events require minimal or no treatment and do not interfere with the participant’s daily activities. 

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 Moderate – Events result in a low level of inconvenience or concern with the therapeutic measures. Moderate events may cause some 
interference with functioning. 
 Severe – Events interrupt a participant’s usual daily activity and may require systemic drug therapy or other treatment. Severe events are 
usually potentially life-threatening or incapacitating. 
 
7.2.2
Relationship to Study Intervention
 
The clinician’s assessment of an AE's relationship to study intervention is part of the documentation process, but it is not a factor in determining 
what is or is not reported in the study. If there is any doubt as to whether a clinical observation is an AE, the event should be reported. All AEs 
must have their relationship to study intervention assessed. In a clinical trial, the study intervention must always be suspect. To help assess, the 
following guidelines are used. 
 
 Related – The AE is known to occur with the study intervention, there is a reasonable possibility that the study intervention caused the AE, 
or there is a temporal relationship between the study intervention and event. Reasonable possibility means that there is evidence to 
suggest a causal relationship between the study intervention and the AE. 
 
 Not Related – There is not a reasonable possibility that the administration of the study intervention caused the event, there is no temporal 
relationship between the study intervention and event onset, or an alternate etiology has been established. 
7.2.3 Expectedness 
Expected adverse reactions are AEs that are common and known to occur for the study intervention being studied and should be collected in a 
standard, systematic format using a grading scale based on functional assessment or magnitude of reaction. Describe the method of determining 
the expectedness of an AE. Expectedness refers to the awareness of AEs previously observed, not on the basis of what might be anticipated from 
the properties of the study intervention. 
7.3
Time Period and Frequency for Event Assessment and Follow-Up
The occurrence of an AE or SAE may come to the attention of study personnel during study visits and interviews of a study participant presenting 
for medical care, or upon review by a study monitor. All AEs including local and systemic reactions not meeting the criteria for SAEs will be 
captured on the appropriate RF. Information to be collected includes event description, time of onset, clinician’s assessment of severity, 
relationship to study intervention (assessed only by those with the training and authority to make a diagnosis), and time of resolution/stabilization 
of the event. All AEs occurring while on study must be documented appropriately regardless of relationship. All AEs will be followed to adequate 
resolution. 
 
Any medical condition that is present at the time that the participant is screened will be considered as baseline and not reported as an AE. 
However, if the study participant’s condition deteriorates at any time during the study, it will be recorded as an AE. UPs will be recorded in the data 
collection system throughout the study. 
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event at each level of severity to be performed. 
AEs characterized as intermittent require documentation of onset and duration of each episode. 

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The PI will record all reportable events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 
days (for SAEs) after the last day of study participation. At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the 
last visit. Events will be followed for outcome information until resolution or stabilization.  
 
All unresolved adverse events should be followed by the investigator until the events are resolved, the subject is lost to follow-up, or the adverse 
event is otherwise explained.  At the last scheduled visit, the investigator should instruct each subject to report any subsequent event(s) that the 
subject, or the subject’s personal physician, believes might reasonably be related to participation in this study.  The investigator should notify the 
study sponsor of any death or adverse event occurring at any time after a subject has discontinued or terminated study participation that may 
reasonably be related to this study. 
7.4
Reporting Procedures – Notifying the IRB 
7.4.1 Adverse Event Reporting
At each contact with the subject, the investigator must seek information on adverse events by specific questioning and, as appropriate, by 
examination.  Information on all adverse events should be recorded immediately in the source document. All clearly related signs, symptoms, and 
abnormal diagnostic procedures results should be recorded in the source document, though should be grouped under one diagnosis. 
 
All adverse events occurring during the study period must be recorded.  The clinical course of each event should be followed until resolution, 
stabilization, or until it has been determined that the study treatment or participation is not the cause.  Serious adverse events that are still ongoing 
at the end of the study period must be followed up to determine the final outcome.  Any serious adverse event that occurs after the study period 
and is considered to be possibly related to study participation should be recorded and reported immediately. 
 
7.4.2 Serious Adverse Event Reporting
If the report is supplied as a narrative, the minimum necessary information to be provided at the time of the initial report includes:
 
Study identifier 
 
Study Center 
 
Subject number 
 
A description of the event 
Date of onset
Current status
 
Whether study treatment was discontinued 
 
The reason why the event is classified as serious 
 
Investigator assessment of the association 
between the event and study treatment 
7.4.3 Unanticipated Problem Reporting
Incidents or events that meet the OHRP criteria for UPs require the creation and completion of an UP report form. It is the site investigator’s 
responsibility to report UPs to their IRB and to the DCC/study sponsor. The UP report will include the following information: 
 
 Protocol identifying information: protocol title and number, PI’s name, and the IRB project number; 
 A detailed description of the event, incident, experience, or outcome; 
 An explanation of the basis for determining that the event, incident, experience, or outcome represents an UP; 

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 A description of any changes to the protocol or other corrective actions that have been taken or are proposed in response to the UP. 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline: 
 
 UPs that are SAEs will be reported to the IRB and to the DCC/study sponsor within <insert timeline in accordance with policy> of the 
investigator becoming aware of the event. 
 Any other UP will be reported to the IRB and to the DCC/study sponsor within <insert timeline in accordance with policy> of the investigator 
becoming aware of the problem. 
 All UPs should be reported to appropriate institutional officials (as required by an institution’s written reporting procedures), the supporting 
agency head (or designee), and OHRP within<insert timeline in accordance with policy> of the IR’s receipt of the report of the problem from 
the investigator. 
 
7.4.4
Reporting of Pregnancy
N/A 
7.5 Reporting Procedures – Notifying the Study Sponsor 
N.A 
7.6
Reporting Procedures – Participating Investigators 
N/A
 
8
Study Oversight 
There will be no formal data and safety monitoring board for this protocol, as there is only minimal risk associated with participation in the current 
study. We will employ an internal Data Safety Monitoring Plan, managed by Dr. Linda Kahn, and communicate with staff to ensure adequate risk 
assessment, adverse event reporting, compliance with protocol, and drop-out rates, with monthly review of safety data and appropriate reporting 
requirements to the NYU Langone Health IRB. Should unanticipated reportable events, defined as internal or external events (such as deaths, life-
threatening experiences, injuries, breaches of confidentiality, or other problems), occur at any time during or after the research study, Dr. Kahn will 
report them immediately to the NYU Grossman School of Medicine IRB. Any new information indicating a change to the risks or potential benefits 
of the research, any deviation from the protocol, and any possible serious or continued non-compliance will be reported to the NYU Langone 
Health IRB by Dr. Kahn immediately. 
 

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9 
Statistical Considerations 
9.1
Statistical and Analytical Plans
There will not be a formal SAP in this study, as it is a pilot with only 10 participants. Demographics will be compared between members of the 
intervention and control groups to assess the success of the randomization process.  T-tests will be used to compare phthalate metabolite and 
bisphenol levels between the two groups and correlations of chemical levels will be run comparing mothers and infants in the control group. 
9.2 Statistical Hypotheses 
Aim 1: H1: We will successfully recruit participants from within an existing cohort study and collect biosamples from participants and their children 
in a single follow-up study visit.  
 
Aim 2: Chemical levels will be higher among infants in the control group vs. the intervention group. There will be no difference in average chemical 
concentrations between the two groups of mothers. Among controls, different chemicals will be present in breast milk vs. infant urine. 
9.3
Analysis Datasets
We will perform both ITT analysis as well as Per-Protocol Analysis, based on participants’ self-reported compliance, which will be assessed 
periodically throughout the intervention. 
9.4
Description of Statistical Methods
9.4.1 Analysis of the Primary Efficacy Endpoint
Our primary aim is to assess the feasibility of the intervention. There are no relevant statistical endpoints. 
9.4.2 Analysis of the Secondary Endpoints
Our secondary endpoints are concentrations of bisphenols and phthalate metabolites in breastmilk and infant urine. We will perform t-tests to 
compare distributions of chemicals between the two infant groups to assess the effectiveness of the intervention. We will also assess correlations 
of concentrations of individual bisphenols and phthalate metabolites between mothers and children from the control group to assess the relative 
prevalence of these chemicals in diet (measured in maternal breast milk) vs. baby products (infant urine).  
9.4.3
Safety Analyses
There is no risk associated with the intervention being implemented in this study, so there will be no safety analysis.
9.4.4
Adherence and Retention Analyses
We will calculate the percent of participants that complete the study as well as the average adherence to protocol in each of the two arms based 
on participant self-report. 

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9.4.5
Baseline Descriptive Statistics
T-tests and chi-square tests (as appropriate) will be used to assess differences in demographic characteristics between participants in the 
intervention and control groups.  
 
Because this is a pilot analysis, it is not adequately powered to detect statistically significant associations or to permit controlling for covariates or 
multiple comparisons. The sample size (10 total; 5 per group) has been determined based on budgetary considerations. 
9.4.6 Enrollment/Randomization/Masking Procedures
Participants will be assigned to either the intervention or control group on an alternating basis upon enrollment. Because of the nature of the 
intervention (cloth vs. conventional diapers), they will not be blinded. If a participant needs to be replaced, the replacement will be assigned to the 
same group as the participant who withdrew.  
9.4.7 Evaluation of Success of Blinding
N/A 
9.4.8 Breaking the Study Blind/Participant Code
N/A 
 
10 
Source Documents and Access to Source Data/Documents 
Source data is all information, original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction 
and evaluation of the trial.  Source data are contained in source documents.  Examples of these original documents, and data records include: 
hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, 
recorded data from automated instruments, copies or transcriptions certified after verification as being accurate and complete, microfiches, 
photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-
technical departments involved in the clinical trial.  
 
The study case report form (CRF) is the primary data collection instrument for the study.  All data requested on the CRF must be recorded.  All 
missing data must be explained.  If a space on the CRF is left blank because the procedure was not done or the question was not asked, write 
“N/D”.  If the item is not applicable to the individual case, write “N/A”.  All entries should be printed legibly in black ink.  If any entry error has been 
made, to correct such an error, draw a single straight line through the incorrect entry and enter the correct data above it.  All such changes must 
be initialed and dated.  DO NOT ERASE OR WHITE OUT ERRORS.  For clarification of illegible or uncertain entries, print the clarification above 
the item, then initial and date it. 
 
Access to study records will be limited to IRB-approved members of the study team. The investigator will permit study-related monitoring, audits, 
and inspections by the IRB/EC, the sponsor, government regulatory bodies, and University compliance and quality assurance groups of all study 
related documents (e.g. source documents, regulatory documents, data collection instruments, study data etc.).  The investigator will ensure the 
capability for inspections of applicable study-related facilities (e.g. pharmacy, diagnostic laboratory, etc.). 

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Participants who consent to this study are already enrolled in NYU CHES Study, and are also consenting to allowing their data to be shared 
between the Diaper Study and NYU CHES Study. Examples of data that can be shared between the two studies include biospecimen and 
questionnaire responses.  
 
Participation as an investigator in this study implies acceptance of potential inspection by government regulatory authorities and applicable 
University compliance and quality assurance offices. 
 
11
Quality Assurance and Quality Control
 
Bisphenols. Eight bisphenols (BPA, BPAF, BPAP, BPB, BPF, BPP, BPS, and BPZ) will be determined by HPLC-ESI-MS/MS. In our experience 
with Sunmi Lee’s laboratory, coefficients of variation are minimal/good for bisphenols (1–15%). With the use of isotopically labeled internal 
standards, limits of detection (LODs) measured in a recent NYU CHES sample ranged from 0.04-0.50 ng/mL, sufficient for measuring urinary 
bisphenols in non-occupationally exposed subjects.27 Calibration checks as well as method control and fortified samples ensure results are within 
±15% of the nominal value, with duplicates performed within each batch to ensure precision within ±15%.  
 
Phthalate metabolites. Quantitative detection of 22 phthalate metabolites will also involve HPLC-ESI-MS/MS.22 Urine samples will be processed 
using enzymatic deconjugation of glucuronidated phthalate monoesters, followed by solid phase extraction coupled with reverse-phase HPLC-ESI-
MS/MS. Coefficients of variation from samples analyzed in Sunmi Lee’s laboratory are minimal/good for phthalates (1–15%); LODs measured in a 
recent NYU CHES sample ranged from 0.02–0.74 ng/mL. Calibration checks as well as method control and fortified samples ensure results are 
within ±15% of the nominal value, with duplicates performed within each batch to ensure precision within ±15%.  
 
12 
Ethics/Protection of Human Subjects 
12.1 Ethical Standard
The PI will ensure that this study is conducted in full conformity with Regulations for the Protection of Human Subjects of Research codified in 45 
CFR Part 46. 
12.2 Institutional Review Board
The protocol, key information sheet(s), informed consent form(s), recruitment materials, and all participant materials will be submitted to the IRB 
for review and approval. IRB approval will be obtained before any participant is enrolled in this study. Any amendment to the protocol will require 
review and approval by the IRB before the changes are implemented to the study. All changes to the consent materials will be IRB approved; a 
determination will be made regarding whether previously consented participants need to be re-consented. 

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12.3 Informed Consent Process 
12.3.1 Consent and Other Informational Documents Provided to Participants
 
Consent materials describing in detail the study purpose, study procedures, and potential risks are given to the participant and written 
documentation of informed consent is required prior to starting the study protocol. The following consent materials are submitted with this protocol: 
 
 Key information sheet (English) 
 Consent document for mother and infant (English) 
 Participation timeline infographic (English)  
 Contact card for participants to reach out to study staff 
 
We will submit translated documents for IRB review and approval via a Modification at a later time.  
12.3.2 Consent Procedures and Documentation 
 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the study and continues throughout the individual’s 
study participation. Extensive description of risks and possible benefits of participation will be provided to the participants. Consent materials will 
be IRB-approved and potential participants will be asked to read and review the consent documents, which will be either emailed to them or 
handed to them physically, as described in section 4.4.  
An IRB-approved Diaper Study team member will begin the informed consent process with a concise and focused presentation of the key 
information using an IRB-approved Key Information Sheet. If potential participant is interested in learning more about this study, she will have her 
eligibility assessed by study staff. If potential participant is eligible and interested, the study team member will fully explain the research study 
using the IRB-approved Informed Consent template as the consent script and answer any questions that may arise.  
 
All participants will receive a verbal explanation in terms suited to their comprehension of the purposes, procedures, and potential risks of the 
study and of their rights as research participants. Participants will have the opportunity to carefully review the written consent form, ask questions, 
and discuss the study with their family members, friends, or doctor prior to signing or providing verbal consent. The rights and welfare of the 
participants will be protected by emphasizing to them that the quality of their medical care will not be adversely affected if they decline to 
participate in this study. 
 
If potential participant is eligible and would like to take part in this study, and the informed consent process takes place in person: 
 
 
Individual will be asked to sign a paper copy of the Informed Consent. 
 
If potential participant is eligible and would like to take part in this study, the informed consent process takes place remotely (by phone), and the 
individual has the ability to provide an electronic signature:  
 

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Individual will be asked to sign the electronic consent (eConsent) via REDCap. The REDCap eConsent link will be submitted to the IRB for 
review in Research Navigator via Modification before use in the study. Language consistency with the IRB-approved consent will be 
reviewed and approved by the IRB before use.  
 
If potential participant is eligible and would like to take part in this study, the informed consent process takes place remotely (by phone), but the 
individual does not have the technical ability to provide an electronic signature: 
 
 
Individual will verbally indicate their interest in participating in the study to the staff member who is conducting the informed consent. The 
staff member will record this in the participant record on REDCap. The participant will sign the printed consent form at the earliest 
opportunity (e.g., her next prenatal visit, in the hospital following delivery, etc.) before any biospecimens are collected. 
 
At the time of consent, participant will also provide consent for her future child’s participation. A copy of the signed informed consent document will 
be given to the participants for their records either at the time of consent if screening and consent takes place in person or at the earliest possible 
in-person encounter, which is when those providing verbal consent will sign a physical copy of the form and those who eConsented will receive a 
printout of their signed eConsent form. A copy of the signed informed consent document will be stored in the participant’s research record. The 
consent process, including the name of the individual obtaining consent, will be thoroughly documented in the subject’s research record. Any 
alteration to the standard consent process (e.g., use of a translator, consent document presented orally, etc.) and the justification for such 
alteration will likewise be documented.  
12.4 Participant and Data Confidentiality 
 
Information about study subjects will be kept confidential and managed according to the requirements of the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA).  Those regulations require a signed subject authorization informing the subject of the following:  
 
 What protected health information (PHI) will be collected from subjects in this study 
 Who will have access to that information and why 
 Who will use or disclose that information  
 The rights of a research subject to revoke their authorization for use of their PHI.  
In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, retains the ability to use all information 
collected prior to the revocation of subject authorization.  For subjects that have revoked authorization to collect or use PHI, attempts should be 
made to obtain permission to collect at least vital status (i.e. that the subject is alive) at the end of their scheduled study period. 
Participant confidentiality will be strictly held in trust by the participating investigators, their staff, and the sponsor(s) and their agents. This 
confidentiality is extended to cover testing of biological samples and genetic tests in addition to the clinical information relating to participants. 
Therefore, the study protocol, documentation, data, and all other information generated will be held in strict confidence. No information concerning 
the study or the data will be released to any unauthorized third party without prior written approval of the sponsor. 
 
The study monitor, other authorized representatives of the sponsor, or representatives of the IRB may inspect all documents and records required 
to be maintained by the investigator, including but not limited to, medical records (office, clinic, or hospital) and pharmacy records for the 
participants in this study. The clinical study site will permit access to such records. 

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The study participant’s contact information will be securely stored in the Division of Environmental Pediatrics at NYULH for internal use during the 
study. At the end of the study, all records will continue to be kept in a secure location for as long a period as dictated by local IRB and Institutional 
regulations. 
 
All raw data gathered for the study will be kept in a locked cabinet in the Division of Environmental Pediatrics. All computerized data files will be 
maintained on a password-protected computer system on both NYULH MCIT-managed network shared drive set up for this study and on REDCap 
and will only be accessible to trained study personnel. All participants will be assigned a unique identifier (code number) that will be used in all 
computerized files containing study data. A file containing links between participant identity and code number will be maintained in a separate file 
with a separate password and will only be accessible to trained study personnel who must know the participants’ identities to contact participants 
for enrollment, to schedule appointments, to conduct follow-up calls, and/or to manage the data. All study personnel will receive training in human 
subjects’ protection prior to any involvement with participants or study data and will be continuously supervised by Dr. Kahn. 
 
This study will not affect treatment or determine prognosis for an individual participant. Data and samples collected in the study are being used for 
research purposes only. The results from this study will not be shared with participants’ medical providers. Participants will not receive the results 
of their chemical analysis.  
 
To further protect the privacy of study participants, a Certificate of Confidentiality will be obtained from the NIH. This certificate protects identifiable 
research information from forced disclosure. It allows the investigator and others who have access to research records to refuse to disclose 
identifying information on research participation in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, 
or local level. By protecting researchers and institutions from being compelled to disclose information that would identify research participants, 
Certificates of Confidentiality help achieve the research objectives and promote participation in studies by helping assure confidentiality and 
privacy to participants. 
12.4.1 Research Use of Stored Human Specimens or Data
 
Samples and data collected under this study may be used to study EDC exposure in minipuberty.
 
 Access to stored samples and data will be limited to the PI and sub-investigators 
 
 Samples and data will be stored using codes assigned by the investigators. All computerized data files will be maintained on a password-
protected computer system on both NYULH MCIT-managed network shared drive set up for this study and on REDCap and will only be 
accessible to trained study personnel. 
12.5 Future Use of Stored Specimens or Data
Sample storage is optional and subjects may request their samples be removed from storage at any time by contacting the study team.
 
 
Data and specimens collected in the Diaper Study will become part of a broader biobank housed in the Division of Environmental 
Pediatrics, owned by the NYU CHES PI, Dr. Trasande. This research biobank is being created so that researchers in the Division of 

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Environmental Pediatrics can study the life course from preconception, pregnancy, childhood, and adult  
 
 
If an NYU investigator requires de-identified Human Biospecimens from the NYU Langone Environmental Pediatrics Biobank, they will 
place a request to the NYU CHES PI, Dr. Trasande. All requests should include an overview of the proposed research including study 
aims, background, methods, type and amount of samples requested, statistical considerations justifying the number of samples requested, 
and contact information of all involved investigators, study personnel, and source of funding.  
 
 
Researchers from outside institutions carrying out specific research that is not contrary to NYU Langone policies and scientists from 
industry will also be considered. Transfers of Human Biospecimens to outside institutions require a duly authorized agreement between 
NYU/NYU Langone and the recipient of the Human Biospecimens. 
 
 
Requests for use of data or stored biospecimens for scientific purposes will be considered by a committee chaired by Dr. Kahn, the PI of 
this study, that includes faculty with relevant experience 
 
13
Data Handling and Record Keeping
13.1 Data Collection and Management Responsibilities
Data collection is the responsibility of the study personnel at the site under the supervision of the PI. The investigator is responsible for ensuring 
the accuracy, completeness, legibility, and timeliness of the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation of data. Black ink is required to ensure 
clarity of reproduced copies. When making changes or corrections, cross out the original entry with a single line, and initial and date the change. 
DO NOT ERASE, OVERWRITE, OR USE CORRECTION FLUID OR TAPE ON THE ORIGINAL. 
 
Clinical data and clinical laboratory data will be entered into REDCap. The data system includes password protection and internal quality checks, 
such as automatic range checks, to identify data that appear inconsistent, incomplete, or inaccurate. Clinical data will be entered directly from the 
source 
13.2 Study Records Retention
Study documents will be retained for the longer of 3 years after close out or 5 years after final reporting/publication. No records will be destroyed 
without the written consent of the sponsor, if applicable. It is the responsibility of the sponsor to inform the investigator when these documents no 
longer need to be retained. 
13.3 Protocol Deviations

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A protocol deviation is any noncompliance with the study protocol. The noncompliance may be either on the part of the participant, the 
investigator, or the study site personnel. As a result of deviations, corrective actions are to be developed by the site and implemented promptly. 
 
All deviations must be addressed in study source documents and reported to the NYULH IRB. Protocol deviations must be reported to the local 
IRB per their guidelines. The PI and study personnel are responsible for knowing and adhering to their IRB requirements.  
13.4 Publication and Data Sharing Policy 
 
This study will comply with the NIH Public Access Policy, which ensures that the public has access to the published results of NIH funded 
research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central 
upon acceptance for publication. 
 
14
Study Finances
14.1 Funding Source
This study is internally funded through an NYU CEHRT pilot grant.  
Contact: Anna Carrasco (anna.carrasco@nyulangone.org) 
227 East 30th Street 
209-914-2415 
14.2 Costs to the Participant
We do not anticipate any costs to the participant in this study.  
14.3 Participant Reimbursements or Payments
Participants in this study will receive no reimbursements or payments. 
15
Study Administration
15.1 Study Leadership

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This pilot study is led by Dr. Linda Kahn, who is fully responsible for its administration. Sunmi Lee will be Dr. Kahn’s Sub-Investigator, providing 
expertise in quantifying phthalate metabolites and bisphenols in human biosamples. This study will also be supervised by Sub-I Dr. Leo Trasande, 
the PI of NYU CHES. 
 
16 Conflict of Interest Policy 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical industry, is critical. Therefore, any actual 
conflict of interest of persons who have a role in the design, conduct, analysis, publication, or any aspect of this study will be disclosed and 
managed. Furthermore, persons who have a perceived conflict of interest will be required to have such conflicts managed in a way that is 
appropriate to their participation in the study. The study leadership has established policies and procedures for all study group members to 
disclose all conflicts of interest and will establish a mechanism for the management of all reported dualities of interest.  
 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or financial gain greater than the minimum allowable by 
their institution, etc.) must have the conflict reviewed by the NYU Langone Conflict of Interest Committee with a Committee-sanctioned conflict 
management plan that has been reviewed and approved by the study sponsor prior to participation in this study. All NYULH investigators will 
follow the applicable conflict of interest policies. 
17
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12. 
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Kuiper JR, O'Brien KM, Ferguson KK, Buckley JP. Urinary specific gravity measures in the U.S. population: Implications for the adjustment 
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O'Brien KM, Upson K, Cook NR, Weinberg CR. Environmental Chemicals in Urine and Blood: Improving Methods for Creatinine and Lipid 
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18 Attachments
These documents are relevant to the protocol, but they are not considered part of the protocol.  They are stored and modified separately. As such, 
modifications to these documents may not require protocol amendments. 
 
 
Adherence survey 
 
Recruitment script 

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Key information sheet 
 
Informed consent   
 
Study Infographic 
 
Contact card for participants