[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573457":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":57,"collaborators":12,"id":59,"slug":12,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":12,"maxAge":67,"enrollmentInfo":68,"targetDuration":12,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":80,"overallStatus":40,"whyStopped":12,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Semmelweis University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","NO_INTERVENTION","Standard care for moderate or severe hypoxic-ischemic encephalopathy with hypothermia.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intranasal breast milk","EXPERIMENTAL","Fresh own mother's breast milk expressed within 4 hours, will be administered 2 times daily, 0.4 ml in each nostril for 28 days.",[18],"Biological: Intranasal breast milk",[20],{"type":21,"name":14,"description":22,"armGroupLabels":23,"otherNames":12},"BIOLOGICAL","Own-mother's fresh breast milk (within 4 hours of having been expressed), is administered intranasally to neonates with hypoxic-ischemic encephalopathy receiving therapeutic hypothermia, starting from the first day of life and continuing for 28 days.\n\nDose: 2 times daily, 0.4 ml in each nostril.",[14],[25],{"name":26,"affiliation":27,"role":28},"Unoke Meder, MD, PhD","Department of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary","PRINCIPAL_INVESTIGATOR",[30,34],{"name":26,"role":31,"phone":32,"phoneExt":12,"email":33},"CONTACT","+36303987970","mederunoke@gmail.com",{"name":35,"role":31,"phone":36,"phoneExt":12,"email":37},"Agnes Jermendy, MD, PhD","+36204600798","jermendy@gmail.com",[39],{"facility":27,"status":40,"city":41,"state":12,"zip":42,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Budapest","1083","Hungary",{"type":45,"coordinates":46},"Point",[47,48],19.04045,47.49835,{"lat":48,"lon":47},[51,52,56],{"name":26,"role":31,"phone":32,"phoneExt":12,"email":33},{"name":53,"role":31,"phone":54,"phoneExt":12,"email":55},"Miklos Szabo, MD, PhD","+36208258221","szabo.miklos@semmelweis.hu",{"name":26,"role":28,"phone":12,"phoneExt":12,"email":12},{"type":58,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100573457",false,"NCT06746532","Intranasal Breast Milk Therapy in HIE","Neonatal Intranasal Breast Milk, Impact on Brain Growth in Hypoxic-ischemic Encephalopathy Therapy (NEO-BRIGHT)","NEO-BRIGHT","Inclusion Criteria:\n\n* Moderate or severe hypoxic- ischemic encephalopathy, receiving therapeutic hypothermia\n\n  ≥ 35. gestational week \\\u003C 48 hours of life\n* Hypothermia treatment for 72 hours\n* Parental consent form\n\nExclusion Criteria:\n\n* Congenital malformation\n* Concurrent cerebral lesions\n* ECMO therapy\n* Contraindication of lactation\n* Mother unable or unwilling to provide fresh breast milk\n* Postpartum asphyxia","ALL","48 Hours",{"count":69,"type":70},80,"ESTIMATED","INTERVENTIONAL",[73],"EARLY_PHASE1","This is an open-label prospective single-center randomized controlled trial to evaluate the effect of intranasal breast milk in hypoxic-ischemic encephalopathic neonates receiving therapeutic hypothermia on long term neurodevelopmental outcome compared to standard care.",[76,77,78,79],"Hypoxic-Ischaemic Encephalopathy","Neonatal Encephalopathy","Perinatal Asphyxia","Neonatal Hypoxic Ischemic Encephalopathy",[81,82,83,84,85,86],"HIE","intranasal breast milk","perinatal asphyxia","brain","breast milk stem cells","hypoxic-ischemic encephalopathy","2024-12-20",{"date":89,"type":90},"2024-12-24","ACTUAL",{"date":92,"type":70},"2025-02-01",{"date":94,"type":70},"2030-12",{"name":5,"class":6},1]