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

Civil Hospices of Lyon

Status: Not yet enrolling

Conditions: Endocrine Disruptors in Newborns and Infants

Treatments: Biological: Urinary dosage; Other: Questionnaires; Behavioral: Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07349927

2025-A01198-41 (Other Identifier)

69HCL24_0017

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: Under 5 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Training group

Experimental group

Description:

Parents attending a training course on endocrine disruptors one month after enrolment (Month 1)

Treatment:

Behavioral: Training

Other: Questionnaires

Biological: Urinary dosage

Control group

Other group

Description:

Parents attending a training course on endocrine disruptors two months after enrolment (Month 2)

Treatment:

Behavioral: Training

Other: Questionnaires

Biological: Urinary dosage