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Phthalate and Bisphenol Exposure During Minipuberty

NCT05864209 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-06-10

Study results available
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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.

Conditions

  • Phthalate Exposure
  • Bisphenol Exposure

Interventions

OTHER

Phthalate- and Bisphenol-free Baby Products

3-month supply. Products include wipes and diaper cream.

OTHER

Cloth Diapers

Subscription to cloth diaper service.

OTHER

Conventional Disposable Diapers

3-month supply.

OTHER

Conventional Baby Products

Products include wipes and diaper cream.

Sponsors & Collaborators

Principal Investigators

  • Linda G Kahn, PhD, MPH · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-16
Primary Completion
2024-01-11
Completion
2024-01-11

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05864209 on ClinicalTrials.gov