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Clinical Trials in France / NCT06268444
Recruiting Not applicable

Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants

NCT06268444 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire, Amiens
Phase
Not applicable
Started
2024-02-07
Last updated
2025-05-22

Condition(s) studied

NewbornChemical Pollutants ExposureSleep

Investigational drug(s) / intervention(s)

7-day actimetry sleep recordingDetermination of environmental pollutants in breast milkMeasurements of environmental pollutants in indoor air deposited on the bracelet worn by the childContinuous recording of the child's temperature for 7 daysUse of a sleep diary for 7 daysParental questionnaire of environmental exposure

7-day actimetry sleep recording: 7-day actimetry sleep recording

Determination of environmental pollutants in breast milk: Determination of environmental pollutants in breast milk

Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child: Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child

Continuous recording of the child's temperature for 7 days: Continuous recording of the child\'s temperature for 7 days

Use of a sleep diary for 7 days: Use of a sleep diary for 7 days

Parental questionnaire of environmental exposure: Parental questionnaire of environmental exposure

Study summary

During their first year of life, children spend more than half their time sleeping, a function essential to their neurodevelopment. This period of maturation and development of the future adult is considered extremely vulnerable to environmental exposure. During this period, the child\'s diet is mainly provided by breastfeeding, where persistent chemical substances have been found. A cocktail of 19 mostly persistent substances (POPs) present in breast milk has recently been identified as the main contributor to neurodevelopmental risk. However, the reality of their impact on neurophysiological development, in particular on infant sleep, has yet to be assessed.

In this project, the sleep of children under 6 months of age will be studied using an actimetry watch worn for 7 days by the child, accompanied by a sleep diary. Exposure to environmental pollutants will be assessed by measuring their presence in the infant\'s milk (breastfeeding) and wearing a silicone bracelet to collect air pollutants. A questionnaire on exposure will complement this evaluation.

Eligibility

Sex
ALL
Min age
—
Max age
6 Months
Healthy volunteers
No
Inclusion Criteria: * Infant less than 6 months of age still on milk diet (total) Exclusion Criteria: * Infants with neurological or neurobehavioral disorders * Families who wish to relocate within 7 days of inclusion * Minor parents deprived of their parental rights, not understanding French, in a state of stress, overwhelmed or vulnerable. * Non-affiliation to a social security system

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CHRU Amiens Amiens France Recruiting

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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 NCT06268444 on ClinicalTrials.gov ↗ ← All trials in France