Parental training to reduce newborn exposure to endocrine disruptors.
Impact of Parental Training in Endocrine Disruptors on the Excretion of Urinary Biomarkers of Exposure: a Randomised Controlled Pilot Study With Two Parallel Arms
NA · Hospices Civils de Lyon · NCT07349927
This project will test whether giving parents simple training can lower newborns' urinary levels of short-lived endocrine disruptors like phthalates.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 0 Days to 5 Days |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Locations | 1 site (Bron) |
| Trial ID | NCT07349927 on ClinicalTrials.gov |
What this trial studies
At Hôpital Femme‑Mère‑Enfant in Bron, parents of full-term, healthy newborns receive brief training and practical advice aimed at reducing exposure to common endocrine-disrupting chemicals. Researchers collect questionnaires and urine samples from infants before and after the intervention to measure short‑half‑life biomarkers such as phthalate metabolites. Because these chemicals are rapidly eliminated in urine, changes can be detected within days, allowing a short-term comparison of excretion levels. The study excludes infants with congenital anomalies and families who do not speak French.
Who should consider this trial
Good fit: Full-term (born after 37 weeks), eutrophic newborns delivered at the Bron hospital whose parents speak French, have social security coverage, and provide signed consent are eligible.
Not a fit: Babies born preterm, those with congenital anomalies, infants whose parents do not speak French, and exposures caused by long‑half‑life chemicals that accumulate in the body (like PFAS) are unlikely to see benefit from this short-term intervention.
Why it matters
Potential benefit: If successful, the approach could lower infants' exposure to harmful chemicals during a vulnerable period and reduce potential long-term health risks.
How similar studies have performed: Previous short-term interventions giving families product-use and dietary advice have shown reductions in urinary levels of short‑lived endocrine disruptors such as phthalates, so the approach has some supporting evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newborns born at the Bron hospital after 37 weeks of amenorrhea * Eutrophic * Affiliated to a social security scheme or beneficiary of a similar scheme * Consent signed by parents Exclusion Criteria: * Congenital anomaly diagnosed antenatally or postnatally * Parents who do not speak French
Where this trial is running
Bron
- Service de gynécologie obstétrique, Hôpital Femme-Mère-Enfant — Bron, France (RECRUITING)
Study contacts
- Study coordinator: Aurélie PORTEFAIX, Dr
- Email: aurelie.portefaix@chu-lyon.fr
- Phone: +33472357999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endocrine Disruptors in Newborns and Infants, Endocrine Disruptors, Phtalate, Newborns, Exposition, Urinary biomarkers, Parental training