Phthalate and Bisphenol Exposure During Minipuberty
An Intervention to Reduce Phthalate and Bisphenol Exposure During the Critical Period of Minipuberty
1 other identifier
interventional
10
1 country
2
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. Investigators will recruit 10 participants from the ongoing NYU Children's Health and Development Study (CHES) cohort study who are \>=37 weeks gestation, carrying a male fetus, and intending to breastfeed. Investigators will randomly assign them to use either conventional baby products or phthalate- and bisphenol-free baby products for the first three months of their children's lives. Toward the end of the intervention, investigators will collect maternal breast milk and infant urine, and assay samples for phthalate metabolite and bisphenol concentrations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2023
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2023
CompletedStudy Start
First participant enrolled
May 16, 2023
CompletedFirst Posted
Study publicly available on registry
May 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2024
CompletedResults Posted
Study results publicly available
May 21, 2025
CompletedJune 10, 2025
May 1, 2025
8 months
May 9, 2023
March 10, 2025
May 22, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Log Signal Intensity of Bisphenol A (BPA) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via non-targeted HPLC-MS/MS. The log signal intensity, an arbitrary unit, is a measurement of the signal strength of BPA in child urine; as the concentration of BPA increases, the signal intensity increases proportionally in a logarithmic fashion; higher values indicate greater infant exposure to bisphenol.
Month 3
Log Signal Intensity of Bisphenol A (BPA) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via non-targeted HPLC-MS/MS. The log signal intensity, an arbitrary unit, is a measurement of the signal strength of BPA in child urine; as the concentration of BPA increases, the signal intensity increases proportionally in a logarithmic fashion; higher values indicate greater maternal exposure to bisphenol.
Month 3
Secondary Outcomes (22)
Mean Concentrations of Monomethyl Phthalate (mMP) in Child Urine Samples
Month 3
Mean Concentrations of Monomethyl Phthalate (mMP) in Maternal Urine Samples
Month 3
Mean Concentrations of Monoethyl Phthalate (mEP) in Child Urine Samples
Month 3
Mean Concentrations of Monoethyl Phthalate (mEP) in Maternal Urine Samples
Month 3
Mean Concentrations of Phthalic Acid (PA) in Child Urine Samples
Month 3
- +17 more secondary outcomes
Study Arms (2)
Intervention Group
EXPERIMENTALHalf 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. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Control Group
ACTIVE COMPARATORHalf 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). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Interventions
3-month supply. Products include wipes and diaper cream.
Eligibility Criteria
You may qualify if:
- Enrolled in NYU CHES study at the NYULH-Brooklyn campus
- years of age or older
- At least 37 weeks gestation
- Carrying a male singleton fetus
- Intending to breastfeed
- English or Spanish speaking
- Intending for pediatric care for infant to occur at the Sunset Park Family Health Center at NYU Langone
You may not qualify if:
- Not enrolled in NYU CHES study from the NYULH-Brooklyn campus
- Under 37 weeks gestation
- Carrying a female fetus
- Carrying multiples
- Not intending to breastfeed
- Not comfortable communicating in English or Spanish
- Not intending for pediatric care for infant to occur at NYULH Sunset Park Family Health Center
- Under 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sunset Park Family Health Center at NYU Langone - Second Avenue
Brooklyn, New York, 11220, United States
Tisch Hospital
New York, New York, 10016, United States
MeSH Terms
Interventions
Results Point of Contact
- Title
- Linda G Kahn, PhD, MPH
- Organization
- NYU Langone Health
Study Officials
- PRINCIPAL INVESTIGATOR
Linda G Kahn, PhD, MPH
NYU Langone Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2023
First Posted
May 18, 2023
Study Start
May 16, 2023
Primary Completion
January 11, 2024
Study Completion
January 11, 2024
Last Updated
June 10, 2025
Results First Posted
May 21, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to linda.kahn@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: linda.kahn@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.