[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573513":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":55,"collaborators":19,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":19,"maxAge":66,"enrollmentInfo":67,"targetDuration":19,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":82,"overallStatus":37,"whyStopped":19,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Semmelweis University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intranasal breast milk","EXPERIMENTAL","Study participants receive their own mother's fresh breast milk, expressed within 4 hours, administered 2 times daily, 0.4 ml in each nostril for 28 days.",[13],"Biological: Intranasal breast milk",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Neonates with hypoxic-ischemic encephalopathy receive their own-mother's fresh breast milk intranasally, starting from the first 48 hours of life and continuing for 28 days. Dose: 2 times daily, 0.4 ml in each nostril (15 minutes apart).",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Unoke Meder, MD, PhD","Department of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary","PRINCIPAL_INVESTIGATOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},"CONTACT","+36303987970","mederunoke@gmail.com",{"name":31,"role":27,"phone":32,"phoneExt":19,"email":33},"Agnes Jermendy, MD, PhD","+36204600798","jermendy@gmail.com",[35],{"facility":36,"status":37,"city":38,"state":19,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Division of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary","RECRUITING","Budapest","1083","Hungary","HU",{"type":43,"coordinates":44},"Point",[45,46],19.04045,47.49835,{"lat":46,"lon":45},[49,50,54],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},{"name":51,"role":27,"phone":52,"phoneExt":19,"email":53},"Miklos Szabo, MD, PhD","+36208258221","szabo.miklos@semmelweis.hu",{"name":22,"role":24,"phone":19,"phoneExt":19,"email":19},{"type":56,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100573513","early-phase-1-feasibility-and-safety-of-intranasally-administered-breast-milk-in-hie-100573513",false,"NCT06747260","Feasibility and Safety of Intranasally Administered Breast Milk in HIE","Feasibility and Safety of Intranasal Breast Milk in Hypoxic-ischaemic Encephalopathy","F-NEO-BRIGHT","Inclusion Criteria:\n\n* Moderate or severe hypoxic- ischaemic encephalopathy, receiving therapeutic hypothermia\n* ≥ 35. gestational week\n* \\\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":68,"type":69},10,"ESTIMATED","INTERVENTIONAL",[72],"EARLY_PHASE1","This is a prospective intervention single center study to evaluate the feasibility and safety of intranasal breast milk in hypoxic-ischaemic encephalopathic neonates receiving therapeutic hypothermia.",[75,76,77,78,79,80,81],"Hypoxic Ischaemic Encephalopathy (HIE)","Hypoxic Ischemic Encephalopathy of Newborn","Neonatal Encephalopathy","Neonatal Hypoxic Ischemic Encephalopathy","Brain Injury","Perinatal Asphyxia","Perinatal Asphyxia , Moderate to Severe HIE",[83,84,85,86,87,9],"Hypoxic-ischaemic encephalopathy","Neonatal encephalopathy","Perinatal asphyxia","Breast milk","Breast milk stem cells","2025-05-19",{"date":90,"type":91},"2025-05-22","ACTUAL",{"date":93,"type":91},"2024-11-22",{"date":95,"type":69},"2030-01-01",{"name":5,"class":6},1]