Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants

Not Applicable

Recruiting

• Conditions: Chemical Pollutants Exposure; Sleep; Newborn
• Interventions: Device: 7-day actimetry sleep recording; Other: Determination of environmental pollutants in breast milk; Other: Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child; Other: Continuous recording of the child's temperature for 7 days; Other: Use of a sleep diary for 7 days; Other: Parental questionnaire of environmental exposure

• Registration Number: NCT06268444
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-07
• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-13
• Study First Posted: 2024-02-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
New born	Determination of environmental pollutants in breast milk	-
New born	7-day actimetry sleep recording	-
New born	Continuous recording of the child's temperature for 7 days	-
New born	Parental questionnaire of environmental exposure	-
New born	Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child	-
New born	Use of a sleep diary for 7 days	-

Primary Outcome Measures

Name	Time	Method
total sleep time per day in infants using actimetry	7 days	total sleep time per day (min)) in infants using actimetry

Secondary Outcome Measures

Name	Time	Method
concentration of chemical polluants on newborn bracelets	1 day
Concentration of various substances in breast milk	1 day
Child Temperature level (°C)	7 days

Trial Locations

Locations (1)

CHRU Amiens; 🇫🇷 Amiens, France