N/A
N=10
Phthalate and Bisphenol Exposure During Minipuberty
Phthalate Exposure · Bisphenol Exposure
Bottom Line
View on ClinicalTrials.gov: NCT05864209 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Log Signal Intensity of Bisphenol A (BPA) in Child Urine Samples — 0.00; 5.43 Log(Arbitrary Units)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Phthalate- and Bisphenol-free Baby Products (Other); Cloth Diapers (Other); Conventional Disposable Diapers (Other); Conventional Baby Products (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Log Signal Intensity of Bisphenol A (BPA) in Child Urine Samples |
0.00; 5.43 | — |
| PRIMARY Log Signal Intensity of Bisphenol A (BPA) in Maternal Urine Samples |
3.49; 4.74 | — |
| SECONDARY Mean Concentrations of Monomethyl Phthalate (mMP) in Child Urine Samples |
27.23; 13.79 | — |
| SECONDARY Mean Concentrations of Monomethyl Phthalate (mMP) in Maternal Urine Samples |
2.91; 5.10 | — |
| SECONDARY Mean Concentrations of Monoethyl Phthalate (mEP) in Child Urine Samples |
129.68; 1649.72 | — |
| SECONDARY Mean Concentrations of Monoethyl Phthalate (mEP) in Maternal Urine Samples |
89.40; 53.30 | — |
| SECONDARY Mean Concentrations of Phthalic Acid (PA) in Child Urine Samples |
24.18; 161.58 | — |
| SECONDARY Mean Concentrations of Phthalic Acid (PA) in Maternal Urine Samples |
63.96; 211.21 | — |
| SECONDARY Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Child Urine Samples |
0.42; 6.81 | — |
| SECONDARY Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Maternal Urine Samples |
8.15; 2.43 | — |
| SECONDARY Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Child Urine Samples |
0.50; 2.92 | — |
| SECONDARY Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Maternal Urine Samples |
1.90; 2.12 | — |
| SECONDARY Mean Concentrations of Monobutyl Phthalate (mBP) in Child Urine Samples |
62.77; 37.40 | — |
| SECONDARY Mean Concentrations of Monobutyl Phthalate (mBP) in Maternal Urine Samples |
18.02; 21.75 | — |
| SECONDARY Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Child Urine Samples |
74.45; 28.25 | — |
| SECONDARY Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Maternal Urine Samples |
13.07; 10.12 | — |
| SECONDARY Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Child Urine Samples |
2.51; 20.00 | — |
| SECONDARY Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Maternal Urine Samples |
8.27; 3.06 | — |
| SECONDARY Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Child Urine Samples |
0.39; 5.06 | — |
| SECONDARY Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Maternal Urine Samples |
4.34; 1.37 | — |
| SECONDARY Mean Concentrations of Bisphenol S (BPS) in Child Urine Samples |
2.09; 1.61 | — |
| SECONDARY Mean Concentrations of Bisphenol S (BPS) in Maternal Urine Samples |
1.80; 0.57 | — |
| SECONDARY Mean Concentrations of Mono-carboxy-isononyl Phthalate (mCINP) in Maternal Urine Samples |
0.59; 1.52 | — |
| SECONDARY Mean Concentrations of Ono-carboxy-isononyl Phthalate (mCINP) in Child Urine Samples |
0.61; 1.06 | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT05864209). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.