protocolSection identificationModule nctId: NCT06268444, orgStudyIdInfo id: PI2023_843_0077, briefTitle: Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants, acronym: SOLANGE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire, Amiens, class: OTHER, descriptionModule briefSummary: 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\&#39;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\&#39;s milk (breastfeeding) and wearing a silicone bracelet to collect air pollutants. A questionnaire on exposure will complement this evaluation., conditionsModule conditions: Newborn, conditions: Chemical Pollutants Exposure, conditions: Sleep, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: 7-day actimetry sleep recording, interventions name: Determination of environmental pollutants in breast milk, interventions name: Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child, interventions name: Continuous recording of the child&#39;s temperature for 7 days, interventions name: Use of a sleep diary for 7 days, interventions name: Parental questionnaire of environmental exposure, outcomesModule primaryOutcomes measure: total sleep time per day in infants using actimetry, secondaryOutcomes measure: Concentration of various substances in breast milk, secondaryOutcomes measure: concentration of chemical polluants on newborn bracelets, secondaryOutcomes measure: Child Temperature level (°C), eligibilityModule sex: ALL, maximumAge: 6 Months, stdAges: CHILD, contactsLocationsModule locations facility: CHRU Amiens, status: RECRUITING, city: Amiens, zip: 80054, country: France, contacts name: Karen CHARDON, Pr, role: CONTACT, phone: 03.22.82.78. 65, email: Karen.chardon@u-picardie.fr, contacts name: Elodie HARAUX, HARAUX, role: PRINCIPAL_INVESTIGATOR, contacts name: Pierre TOURNEUX, Pr, role: SUB_INVESTIGATOR, geoPoint lat: 49.9, lon: 2.3, hasResults: False