[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645456":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":35,"responsibleParty":52,"collaborators":28,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":28,"enrollmentInfo":64,"targetDuration":28,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":76,"overallStatus":80,"whyStopped":28,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Centre Hospitalier Universitaire, Amiens","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-Perinatal Asphyxia","ACTIVE_COMPARATOR","* Full-term infants (born between 36 and 42 weeks of gestation), clinically \"normal\" and without PA. Infants must have birth weights within the normal range for their gestational age.\n* Satisfactory Apgar scores at 1, 3, and 5 minutes, indicating good health.\n* Meet specific biochemical biomarker criteria as defined by the study protocols.\n* No major complications should occur during pregnancy or delivery.",[13],"Device: EEG",{"label":15,"type":10,"description":16,"interventionNames":17},"At-Risk Perinatal Asphyxia","The at-risk PA cohort includes newborns who are:\n\n* Identified by healthcare professionals as being at risk based on criteria that do not exceed the diagnostic thresholds for PA but whose combined assessment of maternal, fetal, and neonatal medical criteria suggests risk factors and early signs of potential PA,\n* OR\n* Classified as such based on biochemical markers identified in WP1 (see WP1)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Confirmed Perinatal Asphyxia","* Newborns diagnosed with PA and treated with hypothermia. The inclusion criteria for this group allow for various modes of delivery, complications during pregnancy and delivery, and a range of gestational ages, as long as they meet the criteria for PA.\n* Birth weight must be ≥ 1800 g.\n* Apgar scores at 1, 3, and 5 minutes must indicate potential complications or difficulties.\n* Specific biochemical markers indicative of PA must be present",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","EEG","electroencephalogram",[15,19,9],null,[30],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Fabrice Wallois, Pr","CONTACT","33+3 22 087775","wallois.fabrice@chu-amiens.fr",[36],{"facility":37,"status":28,"city":38,"state":28,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"CHU Amiens","Amiens","80054","France","FR",{"type":43,"coordinates":44},"Point",[45,46],2.3,49.9,{"lat":46,"lon":45},[49],{"name":50,"role":32,"phone":51,"phoneExt":28,"email":34},"Fabrice WALLOIS, MD, PhD","03 22 08 77 77",{"type":53,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100645456","multimodal-analysis-of-early-biomarkers-of-the-impacts-of-perinatal-asphyxia-100645456",false,"NCT07702500","Multimodal Analysis of Early Biomarkers of the Impacts of Perinatal Asphyxia","Neurobiom","Inclusion Criteria:\n\n* Non-Perinatal Asphyxia Cohort:\n\nThe non-PA cohort includes:\n\n* Full-term infants (born between 36 and 42 weeks of gestation), clinically \"normal\" and without PA. Infants must have birth weights within the normal range for their gestational age.\n* Satisfactory Apgar scores at 1, 3, and 5 minutes, indicating good health.\n* Meet specific biochemical biomarker criteria as defined by the study protocols.\n* No major complications should occur during pregnancy or delivery.\n\n  * At-Risk Perinatal Asphyxia Cohort:\n\nThe at-risk PA cohort includes newborns who are:\n\n* Identified by healthcare professionals as being at risk based on criteria that do not exceed the diagnostic thresholds for PA but whose combined assessment of maternal, fetal, and neonatal medical criteria suggests risk factors and early signs of potential PA,\n* OR\n* Classified as such based on biochemical markers identified in WP1 (see WP1).\n\n  * Confirmed Perinatal Asphyxia Cohort:\n\nThe PA cohort includes:\n\n* Newborns diagnosed with PA and treated with hypothermia. The inclusion criteria for this group allow for various modes of delivery, complications during pregnancy and delivery, and a range of gestational ages, as long as they meet the criteria for PA.\n* Birth weight must be ≥ 1800 g.\n* Apgar scores at 1, 3, and 5 minutes must indicate potential complications or difficulties.\n* Specific biochemical markers indicative of PA must be present\n\nExclusion Criteria:\n\n* Full-term newborn not meeting inclusion criteria",true,"ALL","1 Day",{"count":65,"type":66},280,"ESTIMATED","INTERVENTIONAL",[69],"NA","Current diagnostic methods rely primarily on clinical symptoms, supplemented by brain imaging and physiological tests. However, these signs of injury only become apparent once significant damage has occurred, thus delaying intervention and compromising the effectiveness of treatments. Therefore, there is a need to develop new markers to develop preventive measures for the consequences of perinatal asphyxia.\n\nThe primary objective is to compare cognitive and motor development at 18 months in three populations (PA, at risk of PA, and Control) defined on the basis of clinical, biological, and neural criteria.",[72,73,25,74,75],"Neonate","Asphyxia","Eye Tracking","Biomarkers",[72,77,78,25,79,75],"asphyxia","anoxo ischemia","Eye tracking","NOT_YET_RECRUITING","2026-07-09",{"date":83,"type":84},"2026-07-14","ACTUAL",{"date":86,"type":66},"2026-07",{"date":88,"type":66},"2029-12",{"name":5,"class":6},1]