Clinical trial NCT05864209: Phthalate and Bisphenol Exposure During Minipuberty
Official title: An Intervention to Reduce Phthalate and Bisphenol Exposure During the Critical Period of Minipuberty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phthalate Exposure
Bisphenol Exposure
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Log Signal Intensity of Bisphenol A (BPA) in Child Urine Samples
timeFrame: Month 3
measure: Log Signal Intensity of Bisphenol A (BPA) in Maternal Urine Samples
timeFrame: Month 3
Secondary outcomes:
measure: Mean Concentrations of Monomethyl Phthalate (mMP) in Child Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Monomethyl Phthalate (mMP) in Maternal Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Monoethyl Phthalate (mEP) in Child Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Monoethyl Phthalate (mEP) in Maternal Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Phthalic Acid (PA) in Child Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Phthalic Acid (PA) in Maternal Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Child Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Maternal Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Child Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Maternal Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Monobutyl Phthalate (mBP) in Child Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Monobutyl Phthalate (mBP) in Maternal Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Child Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Maternal Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Child Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Maternal Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Child Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Maternal Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Bisphenol S (BPS) in Child Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Bisphenol S (BPS) in Maternal Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Mono-carboxy-isononyl Phthalate (mCINP) in Maternal Urine Samples
timeFrame: Month 3
measure: Mean Concentrations of Ono-carboxy-isononyl Phthalate (mCINP) in Child Urine Samples
timeFrame: Month 3
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Sunset Park Family Health Center at NYU Langone - Second Avenue
state: New York
city: New York
country: United States
facility: Tisch Hospital
state: New York
Study officials:
affiliation: NYU Langone Health
name: Linda G Kahn, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: