Phthalate and Bisphenol Exposure During Minipuberty

Study Overview
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Brief Summary
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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.

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

Conditions
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Phthalate Exposure, Bisphenol Exposure

Intervention / Treatment
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* Other: Phthalate- and Bisphenol-free Baby Products
* Other: Cloth Diapers
* Other: Conventional Disposable Diapers
* Other: Conventional Baby Products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in NYU CHES study at the NYULH-Brooklyn campus 18 years of age or older At least 37 weeks gestation Carrying a male singleton fetus Intending to breastfeed English or Spanish speaking Intending for pediatric care for infant to occur at the Sunset Park Family Health Center at NYU Langone Exclusion Criteria: Not enrolled in NYU CHES study from the NYULH-Brooklyn campus Under 37 weeks gestation Carrying a female fetus Carrying multiples Not intending to breastfeed Not comfortable communicating in English or Spanish Not intending for pediatric care for infant to occur at NYULH Sunset Park Family Health Center Under 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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<br>* 3-month supply. Products include wipes and diaper cream.<br>Other: Cloth Diapers<br>* Subscription to cloth diaper service.<br>|
| Active Comparator: Control Group<br>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<br>* 3-month supply.<br>Other: Conventional Baby Products<br>* Products include wipes and diaper cream.<br>|

What is the study measuring?
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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 |