Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 6
SponsorCentre Hospitalier Universitaire, Amiens
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Infant less than 6 months of age still on milk diet (total)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
7-day actimetry sleep recording
Device7-day actimetry sleep recording
Determination of environmental pollutants in breast milk
Other interventionDetermination of environmental pollutants in breast milk
Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child
Other interventionMeasurements of environmental pollutants in indoor air deposited on the bracelet worn by the child
Continuous recording of the child's temperature for 7 days
Other interventionContinuous recording of the child\'s temperature for 7 days
Use of a sleep diary for 7 days
Other interventionUse of a sleep diary for 7 days
Parental questionnaire of environmental exposure
Other interventionParental questionnaire of environmental exposure
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: New bornExperimental treatment 6 interventions
Trial outcomes
Primary outcomes
1
total sleep time per day in infants using actimetry
total sleep time per day (min)) in infants using actimetry
Time frame
7 daysSecondary outcomes
1
Concentration of various substances in breast milk
Time frame
1 day2
concentration of chemical polluants on newborn bracelets
Time frame
1 day3
Child Temperature level (°C)
Time frame
7 daysSponsors and contacts
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Source ClinicalTrials.gov