protocolSection identificationModule nctId: NCT06281093, orgStudyIdInfo id: PI2022_843_0089, briefTitle: Radiofrequency Fields in Neonatology: Exposure and Impact on the Nervous System, acronym: CHARLINE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire, Amiens, class: OTHER, collaborators name: University Hospital, Brest, collaborators name: CHU LYON, collaborators name: University Hospital, Strasbourg, France, collaborators name: University Hospital, Toulouse, descriptionModule briefSummary: Previously, the investigators showed that preterm newborns are exposed chronically to very low radiofrequency levels in average while hospitalized in NICUs. Most of the infants were nevertheless frequently exposed to transient values above 1 V/m. The investigators also showed that an increase in RF exposure is likely to alter the activity of some neurophysiological functions and their regulatory systems in preterm newborns. The investigators hypothesize that above results are extremely specific to the location of the previous study and may be different in other NICU environments.This study will aim at quantifying RF levels to which preterm newborns are exposed during their stay in several NICUs spread across the French territory, and assessing its impact on the central and peripheral nervous systems. The first step of this study will be to quantify the precise, continuous and individual levels of daily RF exposure to which each recruited neonate is subjected during his stay in the different NICUs from birth to 1 week postnatal life. Infants' clinical data (medical history, nutrition, morphology...) will also be continually monitored. At 1 week postnatal life, the investigators will investigate cerebral activity (EEG) and autonomic nervous system activity (ECG, heart rate variability). The impact of RF will be evaluated by analyses of the relationship between exposure levels and the various parameters extracted from the neurophysiological investigation phase., conditionsModule conditions: Preterm Newborn, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: questionary, interventions name: Daily continuous recording of radiofrequency exposure levels, interventions name: Follow-up of daily infants clinical parameters, interventions name: recording of cerebral (EEG), interventions name: autonomic nervous (ECG) activity, outcomesModule primaryOutcomes measure: Variation of the spectral power in the α band (8-12 Hz) of the EEG, secondaryOutcomes measure: variation of the spectral power in the delta (δ, 0.5-4 Hz) of the EEG, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 1 Month, stdAges: CHILD, contactsLocationsModule locations facility: Amiens University Hospital, status: RECRUITING, city: Amiens, state: Picardie, zip: 80054, country: France, contacts name: Pierre Tourneux, MD, role: CONTACT, phone: +33 3 22 66 82 86, email: tourneux.pierre@chu-amiens.fr, contacts name: Erwan STÉPHAN-BLANCHARD, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Stéphane DELANAUD, PhD, role: SUB_INVESTIGATOR, contacts name: Frédéric TELLIEZ, Pr, role: SUB_INVESTIGATOR, contacts name: Karen CHARDON, Pr, role: SUB_INVESTIGATOR, contacts name: Brahim SELMAOUI, Dr, role: SUB_INVESTIGATOR, contacts name: Débora TUKA, role: SUB_INVESTIGATOR, contacts name: Jean-Michel ROUÉ, Pr, role: PRINCIPAL_INVESTIGATOR, contacts name: Marine BUTIN, Pr, role: PRINCIPAL_INVESTIGATOR, contacts name: Pierre KUHN, Pr, role: PRINCIPAL_INVESTIGATOR, contacts name: Géraldine GASCOIN, Pr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.9, lon: 2.3, hasResults: False