18 and older, any sex, with Phthalate Exposure or Bisphenol Exposure. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Log Signal Intensity of Bisphenol A (BPA) in Child Urine SamplesPrimary· Month 3
Child urine samples were analyzed for bisphenols and for phthalate metabolites via non-targeted HPLC-MS/MS. The log signal intensity, an arbitrary unit, is a measurement of the signal strength of BPA in child urine; as the concentration of BPA increases, the signal intensity increases proportionally in a logarithmic fashion; higher values indicate greater infant exposure to bisphenol.
Group
Value
95% CI
Intervention Group
0.00
± 0.00
Control Group
5.43
± 0.16
Log Signal Intensity of Bisphenol A (BPA) in Maternal Urine SamplesPrimary· Month 3
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via non-targeted HPLC-MS/MS. The log signal intensity, an arbitrary unit, is a measurement of the signal strength of BPA in child urine; as the concentration of BPA increases, the signal intensity increases proportionally in a logarithmic fashion; higher values indicate greater maternal exposure to bisphenol.
Group
Value
95% CI
Intervention Group
3.49
± 2.47
Control Group
4.74
± 0.40
Mean Concentrations of Monomethyl Phthalate (mMP) in Child Urine SamplesSecondary· Month 3
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Group
Value
95% CI
Intervention Group
27.23
± NA
Control Group
13.79
± NA
Mean Concentrations of Monomethyl Phthalate (mMP) in Maternal Urine SamplesSecondary· Month 3
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Group
Value
95% CI
Intervention Group
2.91
± 2.66
Control Group
5.10
± 0.41
Mean Concentrations of Monoethyl Phthalate (mEP) in Child Urine SamplesSecondary· Month 3
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Group
Value
95% CI
Intervention Group
129.68
± NA
Control Group
1649.72
± NA
Mean Concentrations of Monoethyl Phthalate (mEP) in Maternal Urine SamplesSecondary· Month 3
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Group
Value
95% CI
Intervention Group
89.40
± 74.36
Control Group
53.30
± 8.78
Mean Concentrations of Phthalic Acid (PA) in Child Urine SamplesSecondary· Month 3
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Group
Value
95% CI
Intervention Group
24.18
± NA
Control Group
161.58
± NA
Mean Concentrations of Phthalic Acid (PA) in Maternal Urine SamplesSecondary· Month 3
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Group
Value
95% CI
Intervention Group
63.96
± 91.12
Control Group
211.21
± 126.69
Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Child Urine SamplesSecondary· Month 3
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Group
Value
95% CI
Intervention Group
0.42
± NA
Control Group
6.81
± NA
Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Maternal Urine SamplesSecondary· Month 3
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Group
Value
95% CI
Intervention Group
8.15
± 7.19
Control Group
2.43
± 0.98
Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Child Urine SamplesSecondary· Month 3
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Group
Value
95% CI
Intervention Group
0.50
± NA
Control Group
2.92
± NA
Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Maternal Urine SamplesSecondary· Month 3
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Group
Value
95% CI
Intervention Group
1.90
± 1.25
Control Group
2.12
± 1.08
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by NYU Langone Health
Last refreshed: 10 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05864209.