CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Phthalate- and Bisphenol-free Baby Products +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05864209
NCT05864209N/ACompleted

An Intervention to Reduce Phthalate and Bisphenol Exposure During the Critical Period of Minipuberty

NYU Langone Health·interventional·Posted May 18, 2023·Updated Jun 10, 2025

In Brief

A clinical study evaluating Phthalate- and Bisphenol-free Baby Products, Cloth Diapers, and 2 other interventions for Phthalate Exposure and Bisphenol Exposure. Completed, enrolled 10 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedMay 18, 2023
Enrollment StartMay 16, 2023
Primary CompletionJan 11, 2024
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 3.1 years ago

Interventions

Phthalate- and Bisphenol-free Baby Productsother

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

Cloth Diapersother

Subscription to cloth diaper service.

Conventional Disposable Diapersother

3-month supply.

Conventional Baby Productsother

Products include wipes and diaper cream.