Phthalate and Bisphenol Exposure During Minipuberty

Phthalate Exposure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05864209
• Other study ID #: 23-00367
• Status: Completed
• Phase: N/A
• Start date: May 16, 2023
• Est. completion date: January 11, 2024

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 11, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Phthalate Exposure

Intervention

Other:
• Phthalate- and Bisphenol-free Baby Products
3-month supply. Products include wipes and diaper cream.
• Cloth Diapers
Subscription to cloth diaper service.
• Conventional Disposable Diapers
3-month supply.
• Conventional Baby Products
Products include wipes and diaper cream.

Locations

Country	Name	City	State
United States	Sunset Park Family Health Center at NYU Langone - Second Avenue	Brooklyn	New York
United States	Tisch Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to Intervention at Month 3	The percentage of participants who adhere to the protocol, based on participant self-report.	Month 3
Secondary	Concentration of Bisphenols in Breastmilk	Bisphenol concentration (µg/L) will be measured in breastmilk samples.	Month 3
Secondary	Concentration of Phthalate Metabolites in Breastmilk	Phthalate metabolite concentration will be measured in breastmilk samples.	Month 3
Secondary	Concentration of Bisphenols in Infant Urine	Bisphenol concentration (µg/L) will be measured in infant urine samples.	Month 3
Secondary	Concentration of Phthalate Metabolites in Infant Urine	Phthalate metabolite concentration will be measured in infant urine samples.	Month 3