[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100379195":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":40,"locations":48,"responsibleParty":108,"collaborators":112,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":125,"sex":130,"minAge":11,"maxAge":131,"enrollmentInfo":132,"targetDuration":11,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":142,"overallStatus":51,"whyStopped":11,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"UMC Utrecht","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Allopurinol","ACTIVE_COMPARATOR",null,[13],"Drug: Allopurinol",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Mannitol",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Allopurinol powder for solution for infusion (PFI) 20 mg\u002Fkg body weight per administration will be administered early postnatally (within 45 minutes and 12 hours after the first dose), preoperatively (12 hours before surgery), intraoperatively (during surgery) and postoperatively (24 hours after surgery) to the neonate in case of a prenatal CCHD diagnosis. Allopurinol PFI will be administered only pre-, intra- and postoperatively to the neonate in case of a postnatal CCHD diagnosis.",[9],{"type":21,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Mannitol","Mannitol powder for solution (PFI) placebo will be administered early postnatally (within 45 minutes and 12 hours after birth), preoperatively (12 hours before surgery), intraoperatively (during surgery), and postoperatively (24 hours after surgery) to the neonate in case of a prenatal CCHD diagnosis. Mannitol PFI-placebo will be administered only pre-, intra- and postoperatively to the neonate in case of a postnatal CCHD diagnosis.",[15],[29,33,35,38],{"name":30,"affiliation":31,"role":32},"Manon JNL Benders, Prof. MD PhD","University Medical Center Utrecht (UMC Utrecht)","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":31,"role":32},"Johannes (Hans) MPJ Breur, MD PhD",{"name":36,"affiliation":31,"role":37},"Nicolaas (Koos) JG Jansen, MD PhD","STUDY_DIRECTOR",{"name":39,"affiliation":31,"role":37},"Raymond Stegeman, MD",[41,45],{"name":30,"role":42,"phone":43,"phoneExt":11,"email":44},"CONTACT","0031887554545","m.benders@umcutrecht.nl",{"name":46,"role":42,"phone":11,"phoneExt":11,"email":47},"Maaike Nijman, MD","m.nijman@umcutrecht.nl",[49,69,79,92],{"facility":50,"status":51,"city":52,"state":11,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University Medical Center Groningen (UMCG)","RECRUITING","Groningen","9700 RB","Netherlands","NL",{"type":57,"coordinates":58},"Point",[59,60],6.56667,53.21917,{"lat":60,"lon":59},[63,65,66,67],{"name":64,"role":42,"phone":11,"phoneExt":11,"email":11},"Arend F Bos, Prof. MD PhD",{"name":36,"role":42,"phone":11,"phoneExt":11,"email":11},{"name":64,"role":32,"phone":11,"phoneExt":11,"email":11},{"name":36,"role":68,"phone":11,"phoneExt":11,"email":11},"SUB_INVESTIGATOR",{"facility":70,"status":71,"city":72,"state":11,"zip":73,"country":54,"countryCode":55,"cosmosGeoPoint":74,"geoPoint":78,"contacts":11},"Radboud University Medical Center Nijmegen (Radboudumc)","ACTIVE_NOT_RECRUITING","Nijmegen","6525 GA",{"type":57,"coordinates":75},[76,77],5.85278,51.8425,{"lat":77,"lon":76},{"facility":80,"status":51,"city":81,"state":11,"zip":82,"country":54,"countryCode":55,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Erasmus Medical Center Rotterdam (Erasmus MC)","Rotterdam","3015 GD",{"type":57,"coordinates":84},[85,86],4.47917,51.9225,{"lat":86,"lon":85},[89,91],{"name":90,"role":42,"phone":11,"phoneExt":11,"email":11},"Ingrid M van Beynum, MD PhD",{"name":90,"role":32,"phone":11,"phoneExt":11,"email":11},{"facility":31,"status":51,"city":93,"state":11,"zip":94,"country":54,"countryCode":55,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Utrecht","3584 EA",{"type":57,"coordinates":96},[97,98],5.12222,52.09083,{"lat":98,"lon":97},[101,102,103,104,105,106,107],{"name":30,"role":42,"phone":11,"phoneExt":11,"email":11},{"name":46,"role":42,"phone":11,"phoneExt":11,"email":11},{"name":30,"role":32,"phone":11,"phoneExt":11,"email":11},{"name":34,"role":32,"phone":11,"phoneExt":11,"email":11},{"name":36,"role":68,"phone":11,"phoneExt":11,"email":11},{"name":39,"role":68,"phone":11,"phoneExt":11,"email":11},{"name":46,"role":68,"phone":11,"phoneExt":11,"email":11},{"type":109,"investigatorFullName":110,"investigatorTitle":111,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","dr. M.J.N.L. Benders","Professor, Head of Neonatology, MD",[113,115,117,119,121],{"name":114,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development",{"name":116,"class":6},"University Medical Center Groningen",{"name":118,"class":6},"Erasmus Medical Center",{"name":120,"class":6},"University Medical Center Nijmegen",{"name":122,"class":6},"ACE Pharmaceuticals BV","100379195","phase-3-cerebrum-and-cardiac-protection-with-allopurinol-in-neonates-with-critical-congenital-heart-disease-requiring-cardiac-surgery-with-cardiopulmonary-bypass-100379195",false,"NCT04217421","Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass","CRUCIAL","Inclusion Criteria:\n\n* Neonates with a prenatally or postnatally confirmed diagnosis of CCHD requiring (anticipated) cardiac surgery with CPB within the first 4 weeks of life.\n* Informed consent provided by both parents.\n\nExclusion Criteria:\n\n* Inability to enroll the patient before the start of delivery in case of prenatal diagnosis, or 24 hours before surgery in case of postnatal diagnosis.\n* Doubt whether the aortic arch anomaly before birth requires cardiac surgery with CPB in the neonatal period.\n* Gestational age below 36 weeks and\u002For birth weight less than 2000 gram.\n* Surgery not requiring cardiopulmonary bypass.\n* Decision for \"comfort care only\".","ALL","1 Month",{"count":133,"type":134},236,"ESTIMATED","INTERVENTIONAL",[137],"PHASE3","Neurodevelopmental impairment due to delayed brain development and brain injury is a fundamental problem in children with critical congenital heart disease (CCHD). Significant longterm motor-, cognitive-, and behavioral problems are the result of early postnatally and perioperatively induced brain injury. Allopurinol, a xanthine oxidase inhibitor, prevents the formation of toxic free oxygen radicals, thereby limiting hypoxia-reperfusion damage. Both animal and neonatal studies suggest that administration of allopurinol reduces hypoxic-ischemic brain injury, is cardioprotective, and safe. This study aims to evaluate the efficacy and safety of allopurinol administered early postnatally and perioperatively in children with a CCHD requiring cardiac surgery with cardiopulmonary bypass.",[140,141],"Congenital Heart Disease in Children","Neuroprotection",[143,141,9,144,145,146,147,148,149,150,151,152],"Congenital Heart Disease","Brain injury","Cardiopulmonary bypass","Brain function","Brain oxygenation","Cardiac function","Neurodevelopmental outcome","Cardiac surgery","Hypoxic-ischemic brain injury","Neonates","2024-05-13",{"date":155,"type":156},"2024-05-16","ACTUAL",{"date":158,"type":156},"2020-02-14",{"date":160,"type":134},"2028-12-31",{"name":110,"class":6},4]