[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100296278":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":44,"collaborators":26,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":26,"maxAge":55,"enrollmentInfo":56,"targetDuration":26,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":26,"overallStatus":65,"whyStopped":66,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Queen Fabiola Children's University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Diet","EXPERIMENTAL","Enteral diet made of Nutrilon without lactose® fortified by concentration",[13],"Dietary Supplement: Nutrilon without lactose® fortified by concentration",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Diet","ACTIVE_COMPARATOR","Enteral diet made of Nutrilon without lactose® fortified by Maltodextrin and oil supplementation.",[19],"Dietary Supplement: Nutrilon without lactose® fortified by Maltodextrin and oil supplementation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Nutrilon without lactose® fortified by concentration","enteral diet with cow milk protein-based infant formula without lactose 20% in place of 14%",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Nutrilon without lactose® fortified by Maltodextrin and oil supplementation","enteral diet with cow milk protein-based infant formula without lactose 14%",[15],[32],{"facility":33,"status":26,"city":34,"state":26,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":26},"Hôpital Universitaire Des Enfants Reine Fabiola","Brussels","1020","Belgium","BE",{"type":39,"coordinates":40},"Point",[41,42],4.34878,50.85045,{"lat":42,"lon":41},{"type":45,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100296278","impact-on-the-nitrogen-balance-autonomy-safety-and-tolerance-of-enteral-diets-made-of-with-nutrilon-without-lactose-fortified-by-concentration-versus-by-maltodextrin-and-oil-supplementationafter-surgery-for-congenital-heart-disease-in-infants-100296278",false,"NCT03136900","Impact on the Nitrogen Balance, Autonomy, Safety and Tolerance of Enteral Diets Made of With Nutrilon Without Lactose® Fortified by Concentration Versus by Maltodextrin and Oil Supplementation,After Surgery for Congenital Heart Disease, in Infants.","Controlled, Randomized, Double-blind, Monocentric Clinical Study Evaluating the Impact on the Nitrogen Balance, Autonomy, Safety and Tolerance of Enteral Diets Made of Nutrilon Without Lactose® Fortified by Concentration Versus by Maltodextrin and Oil Supplementation, After Surgery for Congenital Heart Disease, in Children Aged Zero to Two Years Old","DIETCHIRCARD","Inclusion Criteria:\n\n* Children from 0 to 2 years undergoing cardiac surgery (corrective or palliative) for congenital heart surgery, with or without extracorporeal circulation\n* Expected stay of 5 days in PICU after surgery\n* Expected need of invasive ventilation for 48h after surgery\n* Expected need for enteral feeding during 5 days.\n* Obtaining the informed consent of the child's legal guardian after being informed of the goals, benefits and potential risks of this study\n\nExclusion Criteria:\n\n* Medical indications for specific diet\n* ECMO\n* Dialysis","ALL","2 Years",{"count":57,"type":58},41,"ACTUAL","INTERVENTIONAL",[61],"NA","An adequate nutritional support after a cardiac surgery enhances the morbidity and mortality.\n\nAfter a cardiac surgery, the energy expenditure is estimated to be around 55 kcal\u002Fkg\u002Fd. The caloric intake is not the only important nutritional variable in PICU. The protein intake objective is around 1,5g\u002Fkg\u002Fd in order to reduce muscular catabolism.\n\nThe aim of this study is to compare the impact of an isocaloric enteral diet, either fortified by milk concentration (in order to increase the protein intake) or by a supplement of maltodextrin and oil in children from 0 to 2 years, after surgery for congenital heart disease.",[64],"Congenital Heart Disease in Children","TERMINATED","Recuitment to slow","2020-06-19",{"date":69,"type":58},"2020-06-22",{"date":71,"type":58},"2017-05-03",{"date":73,"type":58},"2020-04-17",{"name":5,"class":6},1]