Phthalate and Bisphenol Exposure During Minipuberty

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

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 Overview

• Status: Completed
• Conditions: Phthalate Exposure; Bisphenol Exposure
• Intervention / Treatment: Other: Phthalate- and Bisphenol-free Baby Products; Other: Cloth Diapers; Other: Conventional Disposable Diapers; Other: Conventional Baby Products

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linda G Kahn, PhD, MPH; Phone Number: (917) 439-8069; Email: linda.kahn@nyulangone.org

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11220
      • Sunset Park Family Health Center at NYU Langone - Second Avenue
    • New York, New York, United States, 10016
      • Tisch Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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.	Other: Phthalate- and Bisphenol-free Baby Products; 3-month supply. Products include wipes and diaper cream.; Other: Cloth Diapers; Subscription to cloth diaper service.
Active Comparator: Control Group; 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.	Other: Conventional Disposable Diapers; 3-month supply.; Other: Conventional Baby Products; Products include wipes and diaper cream.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Intervention at Month 3	The percentage of participants who adhere to the protocol, based on participant self-report.	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Bisphenols in Breastmilk	Bisphenol concentration (µg/L) will be measured in breastmilk samples.	Month 3
Concentration of Phthalate Metabolites in Breastmilk	Phthalate metabolite concentration will be measured in breastmilk samples.	Month 3
Concentration of Bisphenols in Infant Urine	Bisphenol concentration (µg/L) will be measured in infant urine samples.	Month 3
Concentration of Phthalate Metabolites in Infant Urine	Phthalate metabolite concentration will be measured in infant urine samples.	Month 3

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Linda G Kahn, PhD, MPH, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2023
• Primary Completion (Actual): January 11, 2024
• Study Completion (Actual): January 11, 2024

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Estrogens, Non-Steroidal; Estrogens; Antioxidants; Free Radical Scavengers; Bisphenol A
• Other Study ID Numbers: 23-00367

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No