[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550094":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":38,"locations":44,"responsibleParty":116,"collaborators":118,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":123,"sex":129,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":24,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":142,"overallStatus":47,"whyStopped":24,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Nantes University Hospital","OTHER",[8,15],{"label":9,"type":6,"description":10,"interventionNames":11},"CATAMARAN - Pediatrics - Interdisciplinary programme - Nantes Only","The study population will consist of 201 children aged 3 to 11 and their two parents.",[12,13,14],"Other: Blood sampling","Diagnostic Test: Assessment of neurodevelopment (Nantes)","Other: Assessment of the parental stress",{"label":16,"type":6,"description":10,"interventionNames":17},"CATAMARAN - Pediatrics - Unique neuropsychological assessment Associated centers (including Nantes)",[12,18,14],"Diagnostic Test: Assessment of neurodevelopment (CA)",[20,25,30,34],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Blood sampling","An EDTA blood sample will be taken from the children and their two parents. Sample volume will be 2 x 3mL.",[9,16],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"DIAGNOSTIC_TEST","Assessment of neurodevelopment (CA)","The children will be seen by a neuropsychologist, who will then determine whether or not they have neurodevelopmental disorders.",[16],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":24},"Assessment of neurodevelopment (Nantes)","The children will be seen by a multidisciplinary team (including a neuropsychologist), who will then determine whether or not they have neurodevelopmental disorders.",[9],{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":24},"Assessment of the parental stress","Parents' parental stress will be assessed using the Parental Stress Index (PSI) questionnaire.",[9,16],[39],{"name":40,"role":41,"phone":42,"phoneExt":24,"email":43},"Alban Baruteau","CONTACT","02 40 08 77 42","albanelouen.baruteau@chu-nantes.fr",[45,65,77,90,103],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Chu Brest","RECRUITING","Brest","Brittany Region","29200","France","FR",{"type":54,"coordinates":55},"Point",[56,57],-4.48628,48.39029,{"lat":57,"lon":56},[60,63],{"name":61,"role":41,"phone":24,"phoneExt":24,"email":62},"Guillaume DEVERRIERE","Guillaume.deverriere@chu-brest.fr",{"name":61,"role":64,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"facility":66,"status":47,"city":67,"state":49,"zip":68,"country":51,"countryCode":52,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"CHU Rennes","Rennes","35000",{"type":54,"coordinates":70},[71,72],-1.67431,48.11109,{"lat":72,"lon":71},[75],{"name":76,"role":64,"phone":24,"phoneExt":24,"email":24},"Clémence Le Seven",{"facility":78,"status":47,"city":79,"state":80,"zip":81,"country":51,"countryCode":52,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"CHU Nantes","Nantes","Loire-Atlantique","44000",{"type":54,"coordinates":83},[84,85],-1.55336,47.21725,{"lat":85,"lon":84},[88,89],{"name":40,"role":41,"phone":42,"phoneExt":24,"email":43},{"name":40,"role":64,"phone":24,"phoneExt":24,"email":24},{"facility":91,"status":47,"city":92,"state":93,"zip":94,"country":51,"countryCode":52,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"CHU Angers","Angers","Maine-et-Loire","49000",{"type":54,"coordinates":96},[97,98],-0.55202,47.47156,{"lat":98,"lon":97},[101],{"name":102,"role":64,"phone":24,"phoneExt":24,"email":24},"Anne-Sophie Lety",{"facility":104,"status":47,"city":105,"state":106,"zip":107,"country":51,"countryCode":52,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"CHU Tours","Tours","Val de Loire","37000",{"type":54,"coordinates":109},[110,111],0.70398,47.39484,{"lat":111,"lon":110},[114],{"name":115,"role":64,"phone":24,"phoneExt":24,"email":24},"Bruno Lefort",{"type":117,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[119],{"name":120,"class":6},"Angers University","100550094","characterization-and-support-for-neurodevelopmental-disorders-associated-with-congenital-heart-defects-100550094",false,"NCT06442592","Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects","CATAMARAN - Pediatrics : Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects","CATAMARAN Ped","Inclusion Criteria:\n\n* Child (aged 3 to 11) with critical MCC operated on for heart surgery during the first three months of life\n* Parents and child affiliated with or benefiting from a social security or similar scheme\n* Parents' and child's good understanding of the French language\n* Free, informed and written consent of both parents for themselves and for the child\n* Free, informed and written consent of the child aged 6 and over\n* Biological parents\n\nExclusion Criteria:\n\n* Genetic anomaly or malformative syndrome associated with neurodevelopmental abnormalities, identified prior to inclusion\n* Neurodevelopmental assessment not practicable","ALL","3 Years","11 Years",{"count":133,"type":134},1206,"ESTIMATED","INTERVENTIONAL",[137],"NA","The leading cause of birth defects, Congenital Heart Defects (CHD) affect 12 million people worldwide and 41,000 newborns\u002Fyear in Europe. It's a major cause of life-long morbidity and mortality, and a crucial public health issue. More than 50% of childs born with critical CHD will develop Neurodevelopmental Disorders (NDs), requiring specific care and impairing quality of life. NDs corresponds to early and lasting disturbances in cognitive, affective and behavioral development, linked to abnormalities in brain development. They are heterogeneous, affecting language, learning, motor skills, intellectual efficiency, social cognition, attention, memory and executive functions, and are associated with psychosocial difficulties (adaptive behavior, social interactions). This hidden handicap is the main long-term sequels of CHD, even before cardiovascular sequels, in individuals who often underwent multiple heart operations in early childhood. NDs concern not only complex CHD, but also simple CHD repaired in childhood and considered cured.\n\nThe origin of TND associated with CHD is largely unknown. To date, few genetic or environmental causes have been clearly identified, but recent work has suggested that a common origin may link cardiac malformation and neurodevelopmental abnormality.\n\nThe CATAMARAN - Pediatrics project is designed to detect potential neurodevelopmental delays associated with CHD as early as age 3, and to identify individual susceptibility factors involved in the occurrence of NDs in CHD children.",[140,141],"Congenital Heart Defects","Neurodevelopmental Disorder",[140,141,143],"Genetics","2026-03-30",{"date":146,"type":147},"2026-04-03","ACTUAL",{"date":149,"type":147},"2024-07-08",{"date":151,"type":134},"2027-08-08",{"name":5,"class":6},5]