Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 7-day actimetry sleep recording, 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.
- Who it may be relevant to
- Registry conditions: Newborn, Chemical Pollutants Exposure, Sleep. Basic parameters: up to 6 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Infant Sleep and Exposure to Mixture of Environmental Pollutants
Overview
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.
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
Primary outcome measures
- total sleep time per day in infants using actimetry [Time frame: 7 days]
Secondary outcome measures (3)
- Concentration of various substances in breast milk [Time frame: 1 day]
- concentration of chemical polluants on newborn bracelets [Time frame: 1 day]
- Child Temperature level (°C) [Time frame: 7 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- CHRU Amiens — Amiens
Identifiers
NCT: NCT06268444 · PI2023_843_0077