Phthalate and Bisphenol Exposure During Minipuberty

Not Applicable

Completed

• Conditions: Bisphenol Exposure; Phthalate Exposure
• Interventions: Other: Conventional Disposable Diapers; Other: Phthalate- and Bisphenol-free Baby Products; Other: Conventional Baby Products; Other: Cloth Diapers

• Registration Number: NCT05864209
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-09
• Study Start: 2023-05-16
• Study First Posted: 2023-05-18
• Primary Completion: 2024-01-11
• Study Completion: 2024-01-11
• Results First Submitted: 2025-03-10
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-05
• Last Update Submitted: 2025-05-05
• Results First Posted: 2025-05-21
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Enrolled in NYU CHES study at the NYULH-Brooklyn campus
2. 18 years of age or older
3. At least 37 weeks gestation
4. Carrying a male singleton fetus
5. Intending to breastfeed
6. English or Spanish speaking
7. Intending for pediatric care for infant to occur at the Sunset Park Family Health Center at NYU Langone

Exclusion Criteria

1. Not enrolled in NYU CHES study from the NYULH-Brooklyn campus
2. Under 37 weeks gestation
3. Carrying a female fetus
4. Carrying multiples
5. Not intending to breastfeed
6. Not comfortable communicating in English or Spanish
7. Not intending for pediatric care for infant to occur at NYULH Sunset Park Family Health Center
8. Under 18 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Conventional Disposable Diapers	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). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Control Group	Conventional Baby Products	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). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Intervention Group	Cloth Diapers	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. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Intervention Group	Phthalate- and Bisphenol-free Baby Products	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. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.

Primary Outcome Measures

Name	Time	Method
Log Signal Intensity of Bisphenol A (BPA) in Child Urine Samples	Month 3	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.
Log Signal Intensity of Bisphenol A (BPA) in Maternal Urine Samples	Month 3	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.

Secondary Outcome Measures

Name	Time	Method
Mean Concentrations of Monomethyl Phthalate (mMP) in Child Urine Samples	Month 3	Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Mean Concentrations of Monomethyl Phthalate (mMP) in Maternal Urine Samples	Month 3	Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Mean Concentrations of Monoethyl Phthalate (mEP) in Child Urine Samples	Month 3	Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Mean Concentrations of Monoethyl Phthalate (mEP) in Maternal Urine Samples	Month 3	Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Mean Concentrations of Phthalic Acid (PA) in Child Urine Samples	Month 3	Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Mean Concentrations of Phthalic Acid (PA) in Maternal Urine Samples	Month 3	Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Child Urine Samples	Month 3	Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Maternal Urine Samples	Month 3	Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Child Urine Samples	Month 3	Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Maternal Urine Samples	Month 3	Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Mean Concentrations of Monobutyl Phthalate (mBP) in Child Urine Samples	Month 3	Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Mean Concentrations of Monobutyl Phthalate (mBP) in Maternal Urine Samples	Month 3	Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Child Urine Samples	Month 3	Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Maternal Urine Samples	Month 3	Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Child Urine Samples	Month 3	Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Maternal Urine Samples	Month 3	Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Child Urine Samples	Month 3	Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Maternal Urine Samples	Month 3	Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Mean Concentrations of Bisphenol S (BPS) in Child Urine Samples	Month 3	Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

Trial Locations

Locations (2)

Tisch Hospital; 🇺🇸 New York, New York, United States

Sunset Park Family Health Center at NYU Langone - Second Avenue; 🇺🇸 Brooklyn, New York, United States