[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100448262":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":36,"locations":45,"responsibleParty":67,"collaborators":12,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":12,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":97,"whyStopped":12,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Princess Anna Mazowiecka Hospital, Warsaw, Poland","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"control group","NO_INTERVENTION","Patients will receive enteral feeding based on the practice of the leading physician.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"intervention","EXPERIMENTAL","Infants will receive enteral feeding based on the following protocol.\n\nEnteral nutrition Minimal enteral nutrition (MEN) will begin within 72 hours life at 10 to 20. mL\u002Fkg\u002Fday, via bolus gravity breast milk\u002Fdonor human milk. MEN will not be included in the caloric goals.\n\nAdvancements in feeding will be set at 20-30 mL\u002Fkg\u002Fday, but not more than 10ml per feeding portion to reach a goal of 150ml\u002Fkg\u002Fday, but not than 120ml\u002Fkg\u002Fday cases of fluid restriction).\n\nThe goal will be to reach an overall daily caloric intake of minimum 100kcal\u002Fkg\u002Fd.",[18],"Other: enteral feeding as per predefined protocol",[20],{"type":6,"name":21,"description":16,"armGroupLabels":22,"otherNames":12},"enteral feeding as per predefined protocol",[14],[24,28,31,34],{"name":25,"affiliation":26,"role":27},"Renata Bokiniec, MD PhD","Medical University of Warsaw","STUDY_CHAIR",{"name":29,"affiliation":26,"role":30},"Joanna Seliga-Siwecka, MD PhD","STUDY_DIRECTOR",{"name":32,"affiliation":26,"role":33},"Ariel Płotko","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":26,"role":33},"Agata Wojcik-Sep",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":12,"email":41},"Ariel Płotko, MD","CONTACT","004822596136","plotko.ariel@gmail.com",{"name":25,"role":39,"phone":43,"phoneExt":12,"email":44},"004822596155","rbokiniec@wp.pl",[46,58],{"facility":47,"status":12,"city":48,"state":12,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":12},"Department of Neonatology and Neonatal Intensive Care Warsaw Medical University","Warsaw","00-315","Poland","PL",{"type":53,"coordinates":54},"Point",[55,56],21.01178,52.22977,{"lat":56,"lon":55},{"facility":59,"status":12,"city":48,"state":12,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":60,"geoPoint":62,"contacts":63},"Princess Anna Mazowiecka Hospital",{"type":53,"coordinates":61},[55,56],{"lat":56,"lon":55},[64],{"name":65,"role":39,"phone":12,"phoneExt":12,"email":66},"Joanna Seliga-Siwecka","joanna.seliga@wum.edu.pl",{"type":33,"investigatorFullName":65,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Principal investigator","100448262","enteral-feeding-in-infants-with-duct-dependant-lesions-100448262",false,"NCT05117164","Enteral Feeding in Infants With Duct Dependant Lesions.","Effect of Standardised vs Local Preoperative Enteral Feeding Practice on the Incidence of NEC in Infants With Duct Dependent Lesions: a Randomised Control Trial.","CARDIOFEED","Inclusion criteria:\n\n1. Duct dependent congenital heart disease\n2. Term infants\n3. Parental\u002Flegal guardian consent\n\nExclusion criteria:\n\n1. Potential contradictions to early central feeding\n2. Feeding intolerance\n3. Hemodynamic instability\n4. Death\n5. \\> 50% formula based enteral feeding\n6. Birth weight less than 2500g","ALL","1 Minute","72 Hours",{"count":81,"type":82},384,"ESTIMATED","INTERVENTIONAL",[85],"NA","This is a multicenter randomised controlled trial to assess whether standardised enteral feeding in newborns with duct dependenty congenital heart disease decreases the risk of necrotising enterocolitis (NEC). The investigators plan to include a total 384 infants. The study will be carried out in three level III hospitals in Poland. The primary end will be NEC and\u002For death. Secondary end points include weight gain, hospital length of stay, time required to reach full feeding.",[88,89,90,91],"Duct Dependent Lesions","Necrotising Enterocolitis","Death","Growth",[93,94,95,96],"congenital heart disease","nutrition","growth","newborn","NOT_YET_RECRUITING","2022-07-16",{"date":100,"type":101},"2022-07-20","ACTUAL",{"date":103,"type":82},"2022-08-10",{"date":105,"type":82},"2026-12-31",{"name":5,"class":6},2]