[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573457":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":58,"collaborators":12,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":12,"maxAge":69,"enrollmentInfo":70,"targetDuration":12,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":40,"whyStopped":12,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"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,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Budapest","1083","Hungary","HU",{"type":46,"coordinates":47},"Point",[48,49],19.04045,47.49835,{"lat":49,"lon":48},[52,53,57],{"name":26,"role":31,"phone":32,"phoneExt":12,"email":33},{"name":54,"role":31,"phone":55,"phoneExt":12,"email":56},"Miklos Szabo, MD, PhD","+36208258221","szabo.miklos@semmelweis.hu",{"name":26,"role":28,"phone":12,"phoneExt":12,"email":12},{"type":59,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100573457","early-phase-1-intranasal-breast-milk-therapy-in-hie-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":71,"type":72},80,"ESTIMATED","INTERVENTIONAL",[75],"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.",[78,79,80,81],"Hypoxic-Ischaemic Encephalopathy","Neonatal Encephalopathy","Perinatal Asphyxia","Neonatal Hypoxic Ischemic Encephalopathy",[83,84,85,86,87,88],"HIE","intranasal breast milk","perinatal asphyxia","brain","breast milk stem cells","hypoxic-ischemic encephalopathy","2024-12-20",{"date":91,"type":92},"2024-12-24","ACTUAL",{"date":94,"type":72},"2025-02-01",{"date":96,"type":72},"2030-12",{"name":5,"class":6},1]