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NCT05864209 · ClinicalTrials.gov registry record · NA
Phthalate and Bisphenol Exposure During Minipuberty
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT05864209: Completed NA study, sponsored by NYU Langone Health.
NCT05864209 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05864209, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Phthalate- and Bisphenol-free Baby Products
- OTHER Cloth Diapers
- OTHER Conventional Disposable Diapers
- OTHER Conventional Baby Products
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-05-16 |
| Est. Completion | 2024-01-11 |
| Phase | NA |
What the finished NCT05864209 record still lists
NCT05864209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 4 interventions - of which Phthalate- and Bisphenol-free Baby Products is the first listed.
NCT05864209 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05864209 about?
NCT05864209 is a clinical study titled "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...
What is the current status of trial NCT05864209?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2023-05-16. Estimated completion is 2024-01-11.
What interventions are being tested in trial NCT05864209?
The interventions under investigation include: Phthalate- and Bisphenol-free Baby Products (OTHER), Cloth Diapers (OTHER), Conventional Disposable Diapers (OTHER), Conventional Baby Products (OTHER).
Who is sponsoring clinical trial NCT05864209?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05864209's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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