Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants

NCT06268444 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-05-22

No results posted yet for this 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.

Conditions

  • Newborn
  • Chemical Pollutants Exposure
  • Sleep

Interventions

DEVICE

7-day actimetry sleep recording

7-day actimetry sleep recording

OTHER

Determination of environmental pollutants in breast milk

Determination of environmental pollutants in breast milk

OTHER

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

OTHER

Continuous recording of the child's temperature for 7 days

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

OTHER

Use of a sleep diary for 7 days

Use of a sleep diary for 7 days

OTHER

Parental questionnaire of environmental exposure

Parental questionnaire of environmental exposure

Sponsors & Collaborators

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-07
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06268444 on ClinicalTrials.gov