Phthalate ExposureNCT05864209
Phthalate and Bisphenol Exposure During Minipuberty
A study testing Phthalate- and Bisphenol-free Baby Products, Cloth Diapers and Conventional Disposable Diapers in people with Phthalate Exposure and Bisphenol Exposure, run by NYU Langone Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Phthalate Exposure, Bisphenol Exposure
- What is being tested?
- Phthalate- and Bisphenol-free Baby Products, Cloth Diapers and Conventional Disposable Diapers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 May 2023to 11 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sunset Park Family Health Center at NYU Langone - Second Avenue
Brooklyn, New York, 11220
Tisch Hospital
New York, New York, 10016
About this study
Official title: An Intervention to Reduce Phthalate and Bisphenol Exposure During the Critical Period of 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.
- Conditions
- Phthalate Exposure, Bisphenol Exposure
- Being tested
- Phthalate- and Bisphenol-free Baby Products, Cloth Diapers, Conventional Disposable Diapers, Conventional Baby Products
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phthalate- and Bisphenol-free Baby ProductsOther
3-month supply. Products include wipes and diaper cream.
Cloth DiapersOther
Subscription to cloth diaper service.
Conventional Disposable DiapersOther
3-month supply.
Conventional Baby ProductsOther
Products include wipes and diaper cream.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Phthalate- and Bisphenol-free Baby Products; Other: Cloth Diapers |
| Control Group | Active comparator | 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. Receives: Other: Conventional Disposable Diapers; Other: Conventional Baby Products |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Month 3
Secondary outcomes (22)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start16 May 2023
- Primary completion11 Jan 2024
- Study completion11 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Phthalate ExposureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda G Kahn, PhD, MPH, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864209
- Sponsor's protocol ID
- 23-00367
- Status last verified
- May 2025
- First submitted
- 9 May 2023
- Last updated
- 10 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention to Reduce Phthalate and Bisphenol Exposure During the Critical Period of Minipuberty
- ClinicalTrials.gov ID
- NCT05864209
- Acronym / sponsor ID
- 23-00367
- Conditions
- Phthalate Exposure, Bisphenol Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 16 May 2023 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Posted 21 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Phthalate- and Bisphenol-free Baby Products, Other: Cloth DiapersHalf 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. |
| Control Group | Active comparator | Other: Conventional Disposable Diapers, Other: Conventional Baby ProductsHalf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phthalate- and Bisphenol-free Baby Products3-month supply. Products include wipes and diaper cream. | Other | Intervention Group |
| Cloth DiapersSubscription to cloth diaper service. | Other | Intervention Group |
| Conventional Disposable Diapers3-month supply. | Other | Control Group |
| Conventional Baby ProductsProducts include wipes and diaper cream. | Other | Control Group |
Primary outcome
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.
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.
22 secondary outcomes
Mean Concentrations of Monomethyl Phthalate (mMP) in Child Urine Samples
Time frame: Month 3
Mean Concentrations of Monomethyl Phthalate (mMP) in Maternal Urine Samples
Time frame: Month 3
Mean Concentrations of Monoethyl Phthalate (mEP) in Child Urine Samples
Time frame: Month 3
Mean Concentrations of Monoethyl Phthalate (mEP) in Maternal Urine Samples
Time frame: Month 3
Mean Concentrations of Phthalic Acid (PA) in Child Urine Samples
Time frame: Month 3
Mean Concentrations of Phthalic Acid (PA) in Maternal Urine Samples
Time frame: Month 3
Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Child Urine Samples
Time frame: Month 3
Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Maternal Urine Samples
Time frame: Month 3
Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Child Urine Samples
Time frame: Month 3
Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Maternal Urine Samples
Time frame: Month 3
Mean Concentrations of Monobutyl Phthalate (mBP) in Child Urine Samples
Time frame: Month 3
Mean Concentrations of Monobutyl Phthalate (mBP) in Maternal Urine Samples
Time frame: Month 3
Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Child Urine Samples
Time frame: Month 3
Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Maternal Urine Samples
Time frame: Month 3
Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Child Urine Samples
Time frame: Month 3
Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Maternal Urine Samples
Time frame: Month 3
Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Child Urine Samples
Time frame: Month 3
Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Maternal Urine Samples
Time frame: Month 3
Mean Concentrations of Bisphenol S (BPS) in Child Urine Samples
Time frame: Month 3
Mean Concentrations of Bisphenol S (BPS) in Maternal Urine Samples
Time frame: Month 3
Mean Concentrations of Mono-carboxy-isononyl Phthalate (mCINP) in Maternal Urine Samples
Time frame: Month 3
Mean Concentrations of Ono-carboxy-isononyl Phthalate (mCINP) in Child Urine Samples
Time frame: Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda G Kahn, PhD, MPH principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phthalate- and Bisphenol-free Baby Products, Cloth Diapers and Conventional Disposable Diapers in people with Phthalate Exposure and Bisphenol Exposure, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Log Signal Intensity of Bisphenol A (BPA) in Child Urine Samples (time frame: Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.