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Recruiting Not applicable

Impact of Parental Training in Endocrine Disruptors on the Excretion of Urinary Biomarkers in Newborns

NCT07349927 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-03-16
Last updated
2026-03-18

Condition(s) studied

Endocrine Disruptors in Newborns and Infants

Investigational drug(s) / intervention(s)

TrainingQuestionnairesUrinary dosage

Training: Short 4-minute information video on EDs (the investigator present on site during the visit will provide additional information and answer any questions families may have) and a printed brochure (including a list of simple actions to take and reference websites to consult).

Questionnaires: Knowledge and representation questionnaires around EDs Exposure questionnaires Behavior questionnaire HLS-EU16 questionnaire Satisfaction questionnaire

Urinary dosage: Urinary phtalates dosage

Study summary

The impact of the environment on health, responsible for a quarter of all deaths worldwide and costing more than €160 billion a year, is difficult to assess because of the complexity of exposure and interactions. Endocrine disrupters (EDs), which are omnipresent in our daily lives, affect hormone metabolism and can have long-term consequences, including effects on subsequent generations. Although complete avoidance is impossible, it is possible to reduce exposure through simple measures.

EDs can be divided into two groups: those with a short half-life, which are rapidly eliminated through the urine, and those with a long half-life, such as PFAS (Per- and polyfluoroalkyl substances), which accumulate in the body. Short-half-life EPs are particularly interesting for interventional studies, as their rapid elimination means that the impact of actions can be measured in a few days.

Policies to combat EDs, such as phthalate-free cities, have been put in place, but impact assessments are still needed. The national plan to combat EDs is based on improving public knowledge, collecting data on impregnation and looking for alternatives.

Studies show that modifying diet and personal care products can reduce concentrations of ED biomarkers, but the results are difficult to transpose to France. The 'first 1,000 days' (pregnancy, birth, infancy) are a window of vulnerability, providing an ideal opportunity to provide information and reduce exposure.

Environmental health research focuses on assessing exposure using biomarkers and informing the public. Studies on newborns and infants, which are still rare, are essential for a better understanding of the risks. Interventions to limit exposure to EDs with short half-lives can have rapidly measurable effects, and randomised studies are needed to test these reduction strategies.

The hypothesis of the study is that practical parental training in simple gestures can reduce the urinary excretion of short-half-life EDs in infants.

This study will therefore provide data on the exposure of infants prior to dietary diversification and assess the impact of parental information on urinary ED levels.

Eligibility

Sex
ALL
Min age
0 Days
Max age
5 Days
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Comparison of the variation in urinary Mono-n-butyl-phthalate (MBP) levels in infants in the 'training' group versus the 'control' group between Month 1 and Month 2 — Month 1, Month 2
    Comparison of the variation in urinary Mono-n-butyl-phthalate (MBP) levels in infants in the 'training' group versus the 'control' group between Month 1 and Month 2

Trial sites (1)

FacilityCityRegionStatus
Service de gynécologie obstétrique, Hôpital Femme-Mère-Enfant Bron France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07349927 on ClinicalTrials.gov ↗ ← All trials in France