Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants
SOLANGE
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 7, 2024
CompletedFirst Submitted
Initial submission to the registry
February 13, 2024
CompletedFirst Posted
Study publicly available on registry
February 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedMay 22, 2025
May 1, 2025
2 years
February 13, 2024
May 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
total sleep time per day in infants using actimetry
total sleep time per day (min)) in infants using actimetry
7 days
Secondary Outcomes (3)
Concentration of various substances in breast milk
1 day
concentration of chemical polluants on newborn bracelets
1 day
Child Temperature level (°C)
7 days
Study Arms (1)
New born
EXPERIMENTALInterventions
Determination of environmental pollutants in breast milk
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
Parental questionnaire of environmental exposure
Eligibility Criteria
You may qualify if:
- Infant less than 6 months of age still on milk diet (total)
You may not qualify if:
- Infants with neurological or neurobehavioral disorders
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU Amiens
Amiens, 80054, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2024
First Posted
February 20, 2024
Study Start
February 7, 2024
Primary Completion
February 1, 2026
Study Completion
February 1, 2026
Last Updated
May 22, 2025
Record last verified: 2025-05