[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651679":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":10,"responsibleParty":18,"collaborators":20,"id":24,"slug":25,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":29,"acronym":30,"eligibilityCriteria":31,"healthyVolunteers":26,"sex":32,"minAge":33,"maxAge":34,"enrollmentInfo":35,"targetDuration":10,"studyType":38,"phases":10,"briefSummary":39,"conditions":40,"keywords":44,"overallStatus":51,"whyStopped":10,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":10},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Term newborns with suspected HIE",null,"Single study population: term newborns (≥ 36 weeks, ≥ 1800 g) with suspected hypoxic-ischemic encephalopathy in a context of perinatal asphyxia, with an available non-compressed conventional EEG. This is a diagnostic-accuracy validation study (STARD), not a comparative two-arm design. The treated \u002F untreated distinction is a pre-specified analysis subgroup only, not a study group.",[13],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Mathilde LETOUZEY, M.D","CONTACT","+ 33171738599","mathilde.letouzey@aphp.fr",{"type":19,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[21],{"name":22,"class":23},"BPI","UNKNOWN","100651679","eeg-based-decision-support-algorithm-for-hypoxic-ischemic-encephalopathy-in-term-newborns-100651679",false,"NCT07764315","EEG-Based Decision-Support Algorithm for Hypoxic-Ischemic Encephalopathy in Term Newborns","Retrospective Multicenter Validation of a Conventional EEG-Based Decision-Support Algorithm to Discriminate Mild Versus Moderate\u002FSevere Hypoxic-Ischemic Encephalopathy in Term Newborns (Newborn Neuro Digital Project)","COOLDECIDE","Inclusion Criteria:\n\n* No parental opposition to the use of the child's medical data within 1 month of the mailed information notice\n* Gestational age ≥ 36 weeks of amenorrhea\n* Birth weight ≥ 1800 g\n* Born in a context of perinatal asphyxia (any cause) leading to suspected HIE, with EITHER biological signs of metabolic acidosis (pH ≤ 7 or base deficit ≥ 16 mmol\u002FL or lactate ≥ 11 mmol\u002FL within the first hour of life, any blood sample) OR a history of asphyxia with Apgar ≤ 5 at 10 minutes or need for ventilatory resuscitation continued at 10 minutes of life\n* Non-compressed conventional EEG (EEGc) recorded before the 6th hour of life\n* EEG including the signal of active electrodes Fp1, Fp2, T3 and T4\n\nExclusion Criteria:\n\n* Participation in a therapeutic biomedical research liable to modify the EEG tracing\n* Fewer than 20 minutes of artifact-free EEG recording\n* Signal from active electrodes Fp1, Fp2, T3 and T4 not exploitable","ALL","0 Days","1 Day",{"count":36,"type":37},310,"ESTIMATED","OBSERVATIONAL","This retrospective, multicenter, observational study evaluates how well a decision-support algorithm can tell apart mild forms of hypoxic-ischemic encephalopathy (HIE) from moderate or severe forms in full-term newborns born after a lack of oxygen around birth (perinatal asphyxia). The algorithm reads the raw (non-compressed) EEG signal. Its output is compared with the reference reading of the full conventional EEG made by a panel of pediatric neurophysiologists together with the baby's clinical information. The study uses only medical data that already exists and asks nothing of the babies or their families.",[41,42,43],"Hypoxic-Ischemic Encephalopathy","Perinatal Asphyxia","Neonatal Brain Injury",[45,46,47,48,49,50],"conventional EEG","therapeutic hypothermia","decision-support software","term newborn","diagnostic accuracy","medical device software","NOT_YET_RECRUITING","2026-08-11",{"date":54,"type":55},"2026-08-13","ACTUAL",{"date":57,"type":37},"2026-09-16",{"date":59,"type":37},"2027-02-16",{"name":5,"class":6}]