Phthalate and Bisphenol Exposure During Minipuberty

• Sponsor: NYU Langone Health (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05864209
• Collaborator: (none)
• Enrollment: 10
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 5
• Patients Per Site: 5
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Phthalate Exposure; Bisphenol Exposure	Other: Phthalate- and Bisphenol-free Baby Products; Other: Cloth Diapers; Other: Conventional Disposable Diapers; Other: Conventional Baby Products	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: An Intervention to Reduce Phthalate and Bisphenol Exposure During the Critical Period of Minipuberty
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Sep 30, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Adherence to Intervention at Month 3 [Month 3]

   The percentage of participants who adhere to the protocol, based on participant self-report.

Secondary Outcome Measures

1. Concentration of Bisphenols in Breastmilk [Month 3]

   Bisphenol concentration (µg/L) will be measured in breastmilk samples.

2. Concentration of Phthalate Metabolites in Breastmilk [Month 3]

   Phthalate metabolite concentration will be measured in breastmilk samples.

3. Concentration of Bisphenols in Infant Urine [Month 3]

   Bisphenol concentration (µg/L) will be measured in infant urine samples.

4. Concentration of Phthalate Metabolites in Infant Urine [Month 3]

   Phthalate metabolite concentration will be measured in infant urine samples.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunset Park Family Health Center at NYU Langone - Second Avenue	Brooklyn	New York	United States	11220
2	Tisch Hospital	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT05864209
• Other Study ID Numbers: 23-00367
• First Posted: May 18, 2023
• Last Update Posted: May 18, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bisphenol A

Study Results

No Results Posted as of May 18, 2023