[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550444":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":39,"locations":45,"responsibleParty":56,"collaborators":30,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":30,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":30,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":85,"whyStopped":30,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Istanbul Training and Research Hospital","OTHER_GOV",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"The babies fed with bolus feeding during TH","ACTIVE_COMPARATOR","The babies were randomized into three groups; Group 1.The neonates who received bolus feeding,Group 2. The neonates who received continuous feeding Group 3. The control group who were not fed during TH. The control group was composed of historical newborns. Three groups were compared in terms of demographic characteristics and clinical outcomes.",[13],"Dietary Supplement: Bolus feeding",{"label":15,"type":10,"description":16,"interventionNames":17},"The babies fed with continuous feeding during TH","The babies were randomized into three groups; Group 1.The neonates who received bolus feeding,Group 2. The neonates who received continuous feeding Group 3. The control group who were not fed during TH. The control group was composed of historical newborns.Three groups were compared in terms of demographic characteristics and clinical outcomes.",[18],"Dietary Supplement: Continuous feeding",{"label":20,"type":21,"description":16,"interventionNames":22},"The babies who were not fed","PLACEBO_COMPARATOR",[23],"Dietary Supplement: Placebo",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DIETARY_SUPPLEMENT","Bolus feeding","The babies fed with bolus feeding during TH composed this group",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Continuous feeding","The babies fed with continuous feeding during TH composed this group",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Placebo","The babies who were not fed during TH composed this group",[20],[40],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"DİDEM ARMAN","CONTACT","05056211989","dr_didemcaktir@yahoo.com",[46],{"facility":47,"status":30,"city":48,"state":30,"zip":30,"country":49,"countryCode":30,"cosmosGeoPoint":50,"geoPoint":55,"contacts":30},"IstanbulTRH","Istanbul","Turkey (Türkiye)",{"type":51,"coordinates":52},"Point",[53,54],28.94966,41.01384,{"lat":54,"lon":53},{"type":57,"investigatorFullName":41,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Associate Professor","100550444","continuous-versus-bolus-feeding-in-neonates-with-hypoxic-ischemic-encephalopathy-100550444",false,"NCT06447155","Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy","The Impact of Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy Undergoing Therapeutic Hypothermia","Inclusion Criteria:\n\n* The neonates with evidence of encephalopathy de¬fined by seizures or abnormalities on a modified Sarnat exam were enrolled. The hypoxic-ischemic injury was defined by 1. a pH of ≤ 7.0 and\u002For 2. base deficit \\>-16 mmol\u002FL recorded in cord blood or blood gas obtained within the first hour postnatally or a pH of 7.0 - 7.15 and\u002For base deficit (-10-15.9) mmol\u002FL with the presence of an acute perinatal event (cord prolapse, placental abruption, heart rate decelerations, severe fetal bradycardia). In cases where criteria 1 or 2 are met, with the presence of seizures or a diagnosis of moderate to severe encephalopathy according to the Sarnat \\& Sarnat classification based on neurological examination were treated with TH.\n\nExclusion Criteria: Infants with congenital malformation or hereditary metabolic diseases, infants whose enteral feeding was initiated before randomization and infants without lack of parental consent were excluded. The maternal and neonatal demographic characteristics and clinical outcomes were collected from medical records.\n\n\\-","ALL","0 Days","1 Day",{"count":70,"type":71},60,"ESTIMATED","INTERVENTIONAL",[74],"NA","Therapeutic hypothermia (TH) is accepted worldwide as a standard of care for infants born at or beyond 36 weeks gestational age with moderate-to-severe hypoxic ischaemic encephalopathy (HIE).\n\nWhile central nervous system is the most affected organ system , multiorgan dysfunction including renal, pulmonary, cardiac, and\u002For gastrointestinal (GI) compromise is not infrequent. Although the process of 'cooling' itself is well defined, based on high-quality randomized controlled trials, there are few data to inform the provision of nutrition to infants with HIE during and soon after TH.However, breastfeeding plays a beneficial role in maintaining the structural and functional integrity of the gut. It may help to reduce systemic inflammatory response and positively regulates the microbiota. In many studies it is stated that enteral feeding during TH appears to be safe and feasible. There is insufficient evidence to choose the type of enteral feeding either bolus or continuous during TH.\n\nThe present study aimed to compare the impact of different types of enteral feeding in infants with HIE receiving TH.",[77,78],"Hypoxic Ischemic Encephalopathy of Newborn","Feeding Patterns",[80,81,82,83,84],"Newborn","Hypoxic ischemic encephalopathy","Enteral feeding","Bolus","Continuous","NOT_YET_RECRUITING","2024-06-03",{"date":88,"type":89},"2024-06-06","ACTUAL",{"date":91,"type":71},"2024-06-15",{"date":93,"type":71},"2026-06-15",{"name":5,"class":6},1]