[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546401":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":37,"responsibleParty":62,"collaborators":12,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":12,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":12,"maxAge":73,"enrollmentInfo":74,"targetDuration":12,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":40,"whyStopped":12,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Nutricia Foundation","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"control group","NO_INTERVENTION","Control group will be unfed orally during 72 hours of therapeutic hypothermia. The group will be receiving parenteral nutrition (PN) from day one onwards. Parenteral nutrition will be defined as receiving any type of nutrient solution in any volume through any route of administration (peripheral venous cannula, central venous catheter, or umbilical catheter).",null,{"label":14,"type":15,"description":16,"interventionNames":17},"experimental group","EXPERIMENTAL","Experimental group will start receiving enteral feeding at 10 ml\u002Fkg\u002Fday during first day of TH, 20 ml\u002Fkg\u002Fday during second day and 30 ml\u002Fkg\u002Fday during third day.\n\nAdditionally will be receiving parenteral nutrition (PN) from day one onwards. Parenteral nutrition will be defined as receiving any type of nutrient solution in any volume through any route of administration (peripheral venous cannula, central venous catheter, or umbilical catheter). As the volume of enteral feeding will be increased, the volume of PN will be decreased gradually.",[18],"Other: enteral feeding with mother milk or human donor breast milk",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"enteral feeding with mother milk or human donor breast milk","The experimental group will start enteral feeding with mother milk or human donor breast milk if mother milk is not accesible during the first day of therapeutic hypothermia.",[14],[25],{"name":26,"affiliation":27,"role":28},"Viktoryia Parfenchyk, MD","Collegium Medicum Jagiellonian University in Cracow","PRINCIPAL_INVESTIGATOR",[30,34],{"name":26,"role":31,"phone":32,"phoneExt":12,"email":33},"CONTACT","+48 535275959","viktoryia.parfenchyk@uj.edu.pl",{"name":35,"role":31,"phone":12,"phoneExt":12,"email":36},"Matuesz Jagla, MD","mateusz.jagla@uj.edu.pl",[38],{"facility":39,"status":40,"city":41,"state":12,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"University Children's Hospital of Cracow, Neonatal intensive care unit","RECRUITING","Cracow","30-663","Poland","PL",{"type":46,"coordinates":47},"Point",[48,49],19.93658,50.06143,{"lat":49,"lon":48},[52,53,56,58,60],{"name":26,"role":31,"phone":32,"phoneExt":12,"email":33},{"name":54,"role":55,"phone":12,"phoneExt":12,"email":12},"Witold Błaż, MD","SUB_INVESTIGATOR",{"name":57,"role":55,"phone":12,"phoneExt":12,"email":12},"Justyna Ferek, MD",{"name":59,"role":55,"phone":12,"phoneExt":12,"email":12},"Beata Rzepecka-Węglarz, MD",{"name":61,"role":55,"phone":12,"phoneExt":12,"email":12},"Małgorzata Stefańska, MD",{"type":28,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Viktoryia Parfenchyk","Principal Investigator, Physician","100546401","is-feeding-during-therapeutic-hypothermia-safe-and-can-improve-outcomes-in-infants-with-hypoxic-ischaemic-encephalopathy-100546401",false,"NCT06394453","Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy","Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy: a Randomized Controlled Study.","Inclusion Criteria:\n\n1. 35 weeks or more gestational age\n2. \\\u003C 6 hours post birth\n3. Any of the following:\n\n   * Metabolic or mixed acidosis with a pH of ≤7.0 or a base deficit ≥16 mmol\u002FL in an umbilical cord blood sample or any blood obtained within first hour after birth\n   * 10-minute Apgar score of ≤5\n   * Ongoing resuscitation initiated at birth and continued for ≥10 minutes\n4. Moderate to severe encephalopathy on clinical examination, using a Thompson HIE score ≥ 7\n5. Signed informed consent by parent\n\nExclusion Criteria:\n\n1. Critical general condition\n2. Aneuploidies (13 th , 18 th , 21 st )\n3. Birth weight \\\u003C1800 g\n4. Severe congenital defects with poor prognosis\n5. Severe mechanical head injuries\n6. Congenital malformations of digestive system (esophageal atresia, duodenal atresia, gastroschisis, omphalocele, anal atresia)","ALL","6 Hours",{"count":75,"type":76},104,"ESTIMATED","INTERVENTIONAL",[79],"NA","Therapeutic hypothermia (TH) is the standard of care for newborns with moderate to severe hypoxic-ischaemic encephalopathy (HIE) born at 35 weeks or more of gestation. Many neonatal units do not use enteral feeding during TH, in fear of increased risk of complications. Withholding enteral feedings during TH lacks supporting evidence. The aim of the study is to determine if enteral feeding during TH in patients with HIE is safe and assess its effects. Investigators will perform multicenter randomized controlled study in level III neonatal intensive care units on infants qualified for TH. Infants will be randomized into 2 groups: (1) unfed during 72 hours of TH; (2) fed group, which will start receive enteral feeding with mother milk or human donor breast milk at 10 ml\u002Fkg\u002Fday during first day of TH, 20 ml\u002Fkg\u002Fday during second day, 30 ml\u002Fkg\u002Fday during third day. The primary outcome will be (1) combined necrotizing enterocolitis or death, (2) length of hospital stay. The secondary outcomes will be (1) time to full enteral feeding, (2) late-onset sepsis, (3) Test of Infant Motor Performance scoring, (4) MRI scoring, (5) MR spectroscopy parameters.",[82],"Newborn Asphyxia",[84],"therapeutic hypothermia, hypoxic-ischaemic encephalopathy","2024-04-27",{"date":87,"type":88},"2024-05-01","ACTUAL",{"date":90,"type":88},"2024-04-15",{"date":92,"type":76},"2026-12-31",{"name":5,"class":6},1]