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Completed

NCT Number: NCT05864209

Phthalate and Bisphenol Exposure During Minipuberty

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.

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Key information

Conditions

Phthalate Exposure Bisphenol Exposure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunset Park Family Health Center at NYU Langone - Second Avenue, Brooklyn, New York, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phthalate- and Bisphenol-free Baby Products

Other

3-month supply. Products include wipes and diaper cream.

Cloth Diapers

Other

Subscription to cloth diaper service.

Conventional Disposable Diapers

Other

3-month supply.

Conventional Baby Products

Other

Products include wipes and diaper cream.

Primary outcomes

  1. Log Signal Intensity of Bisphenol A (BPA) in Child Urine Samples

    Time frame: 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.

  2. Log Signal Intensity of Bisphenol A (BPA) in Maternal Urine Samples

    Time frame: 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.

Secondary outcomes

  1. Mean Concentrations of Monomethyl Phthalate (mMP) in Child Urine Samples

    Time frame: Month 3

    Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  2. Mean Concentrations of Monomethyl Phthalate (mMP) in Maternal Urine Samples

    Time frame: Month 3

    Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  3. Mean Concentrations of Monoethyl Phthalate (mEP) in Child Urine Samples

    Time frame: Month 3

    Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  4. Mean Concentrations of Monoethyl Phthalate (mEP) in Maternal Urine Samples

    Time frame: Month 3

    Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  5. Mean Concentrations of Phthalic Acid (PA) in Child Urine Samples

    Time frame: Month 3

    Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  6. Mean Concentrations of Phthalic Acid (PA) in Maternal Urine Samples

    Time frame: Month 3

    Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  7. Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Child Urine Samples

    Time frame: Month 3

    Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  8. Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Maternal Urine Samples

    Time frame: Month 3

    Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  9. Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Child Urine Samples

    Time frame: Month 3

    Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  10. Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Maternal Urine Samples

    Time frame: Month 3

    Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  11. Mean Concentrations of Monobutyl Phthalate (mBP) in Child Urine Samples

    Time frame: Month 3

    Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  12. Mean Concentrations of Monobutyl Phthalate (mBP) in Maternal Urine Samples

    Time frame: Month 3

    Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  13. Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Child Urine Samples

    Time frame: Month 3

    Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  14. Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Maternal Urine Samples

    Time frame: Month 3

    Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  15. Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Child Urine Samples

    Time frame: Month 3

    Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  16. Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Maternal Urine Samples

    Time frame: Month 3

    Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  17. Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Child Urine Samples

    Time frame: Month 3

    Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  18. Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Maternal Urine Samples

    Time frame: Month 3

    Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  19. Mean Concentrations of Bisphenol S (BPS) in Child Urine Samples

    Time frame: Month 3

    Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  20. Mean Concentrations of Bisphenol S (BPS) in Maternal Urine Samples

    Time frame: Month 3

    Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  21. Mean Concentrations of Mono-carboxy-isononyl Phthalate (mCINP) in Maternal Urine Samples

    Time frame: Month 3

    Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

  22. Mean Concentrations of Ono-carboxy-isononyl Phthalate (mCINP) in Child Urine Samples

    Time frame: Month 3

    Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 18, 2023
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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