An interventional study of Phthalate- and Bisphenol-free Baby Products and Cloth Diapers in Phthalate Exposure and Bisphenol Exposure, sponsored by NYU Langone Health. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Prevention
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.
NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
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Exclusion Criteria:
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 · Other: Cloth Diapers
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 · Other: Conventional Baby Products
3-month supply. Products include wipes and diaper cream.
Subscription to cloth diaper service.
3-month supply.
Products include wipes and diaper cream.
Log Signal Intensity of Bisphenol A (BPA) in Child Urine Samples
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.
Time frame: Month 3
Log Signal Intensity of Bisphenol A (BPA) in Maternal Urine Samples
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.
Time frame: Month 3
Mean Concentrations of Monomethyl Phthalate (mMP) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Monomethyl Phthalate (mMP) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Monoethyl Phthalate (mEP) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Monoethyl Phthalate (mEP) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Phthalic Acid (PA) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Phthalic Acid (PA) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Monobutyl Phthalate (mBP) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Monobutyl Phthalate (mBP) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Bisphenol S (BPS) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Bisphenol S (BPS) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Mono-carboxy-isononyl Phthalate (mCINP) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Mean Concentrations of Ono-carboxy-isononyl Phthalate (mCINP) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
| Milestone | Intervention Group | Control Group |
|---|---|---|
| Started | 5 | 5 |
| Completed | 3 | 2 |
| Not completed | 2 | 3 |
| Withdrew: Lost to follow-up | 2 | 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.
| Log(Arbitrary Units) | Intervention Group | Control Group |
|---|---|---|
| Log Signal Intensity of Bisphenol A (BPA) in Child Urine Samples | 0.00 ± 0.00 | 5.43 ± 0.16 |
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.
| Log(Arbitrary Units) | Intervention Group | Control Group |
|---|---|---|
| Log Signal Intensity of Bisphenol A (BPA) in Maternal Urine Samples | 3.49 ± 2.47 | 4.74 ± 0.40 |
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Monomethyl Phthalate (mMP) in Child Urine Samples | 27.23 ± NA | 13.79 ± NA |
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Monomethyl Phthalate (mMP) in Maternal Urine Samples | 2.91 ± 2.66 | 5.10 ± 0.41 |
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Monoethyl Phthalate (mEP) in Child Urine Samples | 129.68 ± NA | 1649.72 ± NA |
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Monoethyl Phthalate (mEP) in Maternal Urine Samples | 89.40 ± 74.36 | 53.30 ± 8.78 |
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Phthalic Acid (PA) in Child Urine Samples | 24.18 ± NA | 161.58 ± NA |
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Phthalic Acid (PA) in Maternal Urine Samples | 63.96 ± 91.12 | 211.21 ± 126.69 |
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Child Urine Samples | 0.42 ± NA | 6.81 ± NA |
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Maternal Urine Samples | 8.15 ± 7.19 | 2.43 ± 0.98 |
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Child Urine Samples | 0.50 ± NA | 2.92 ± NA |
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Maternal Urine Samples | 1.90 ± 1.25 | 2.12 ± 1.08 |
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Monobutyl Phthalate (mBP) in Child Urine Samples | 62.77 ± NA | 37.40 ± NA |
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Monobutyl Phthalate (mBP) in Maternal Urine Samples | 18.02 ± 7.21 | 21.75 ± 19.88 |
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Child Urine Samples | 74.45 ± NA | 28.25 ± NA |
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Maternal Urine Samples | 13.07 ± 10.02 | 10.12 ± 7.04 |
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Child Urine Samples | 2.51 ± NA | 20.00 ± NA |
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Maternal Urine Samples | 8.27 ± 6.6 | 3.06 ± 0.58 |
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Child Urine Samples | 0.39 ± NA | 5.06 ± NA |
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Maternal Urine Samples | 4.34 ± 3.16 | 1.37 ± 0.49 |
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Bisphenol S (BPS) in Child Urine Samples | 2.09 ± NA | 1.61 ± NA |
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Bisphenol S (BPS) in Maternal Urine Samples | 1.80 ± 0.82 | 0.57 ± 0.58 |
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Mono-carboxy-isononyl Phthalate (mCINP) in Maternal Urine Samples | 0.59 ± 0.31 | 1.52 ± 1.92 |
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
| microgram/gram creatinine | Intervention Group | Control Group |
|---|---|---|
| Mean Concentrations of Ono-carboxy-isononyl Phthalate (mCINP) in Child Urine Samples | 0.61 ± NA | 1.06 ± NA |
Collected over 3 Months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Control Group | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Mean | 27.02 ± 3.96 | 33.025 ± 13.20 | 30.023 ± 8.58 |
| Sex: Female, Male(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 5 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 2 | 5 |
| Region of Enrollment(participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| United States | 3 | 2 | 5 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: linda.kahn@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Sap
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