NCT05864209

Phthalate and Bisphenol Exposure During Minipuberty

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-05-16
• Primary completion: 2024-01-11
• Completion: 2024-01-11
• First posted: 2023-05-18
• Last updated: 2025-06-10
• Results posted: 2025-05-21

Locations

2 sites across 1 country: United States