[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573047":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":37,"responsibleParty":54,"collaborators":25,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Nantes University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"standard group","ACTIVE_COMPARATOR","The usual medical monitoring for the first six months postoperatively is standardized between the 4 university hospital centres concerned and consists of :\n\n1. during the first 4 weeks: a weekly consultation including a record of intercurrent events (malaise, cyanosis, hyperthermia, eating difficulties), a record of weight and vital constants (oxygen saturation, heart rate), an examination of the sternotomy or thoracotomy scar, a clinical cardiovascular examination, a 12-lead electrocardiogram and a transthoracic echocardiogram.\n2. during the following 20 weeks: a consultation at 1, 3 and 6 months including the same assessment procedures.",[13],"Other: usual medical monitoring",{"label":15,"type":16,"description":17,"interventionNames":18},"home monitoring group","EXPERIMENTAL","In addition to the usual post-operative monitoring, OSCAR home monitoring will enable key parameters to be transmitted to the medical team at a discontinuous rate (once a day for 4 weeks, then once a week for 20 weeks) via a brief questionnaire (smartphone application) and measurement sensors (weight, oxygen saturation, heart rate) linked to an interface, from the first day the patient returns home until the 6th month post-operatively. The values entered will be automatically compared with individualized standards established for each child at a multidisciplinary meeting, and any deviation from the standard will generate an alert. and the response of the medical teams will be protocolized.",[19,13],"Other: Home monitoring",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Home monitoring","The key parameters (heart rate, arterial oxygen saturation, weight) will be measured at home using the measurement tools used by the parents, and tele-transmitted at a discontinuous rate, i.e. once a day for 4 weeks, then once a week for 20 weeks. The measurement tools will be given to the family before discharge from the hospital ward. These parameters will be entered into the Exolis platform, in addition to a very brief questionnaire designed to provide information about the child's diet, muscle tone and any medication he or she is taking. taken by the child.\n\nAn alert will be automatically generated for the pediatric cardiology team if the data transmitted by the measurement sensors deviates from an individualized standard, defined for each child and\u002For each care pathway at the multidisciplinary consultation meeting before the child returns home.\n\nThe response will be standardized on the basis of a protocol shared by the 4 investigating centers.",[15],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"usual medical monitoring","During the first 4 weeks: a weekly consultation including a record of intercurrent events (malaise, cyanosis, hyperthermia, eating difficulties), a record of weight and vital constants (oxygen saturation, heart rate), an examination of the sternotomy or thoracotomy scar, a clinical cardiovascular examination, a 12-lead electrocardiogram and a transthoracic echocardiogram.\n\nDuring the following 20 weeks: a consultation at 1, 3 and 6 months including the same assessment procedures.",[15,9],[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Alban-Elouen Baruteau, Pr","CONTACT","+33","+33240087742","albanelouen.baruteau@chu-nantes.fr",[38],{"facility":39,"status":40,"city":41,"state":25,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"CHU de Nantes","RECRUITING","Nantes","France","FR",{"type":45,"coordinates":46},"Point",[47,48],-1.55336,47.21725,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":53,"phoneExt":25,"email":36},"Alban BARUTEAU","0240087742",{"type":55,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100573047","cardiopediatric-home-monitoring-tool-100573047",false,"NCT06741189","Cardiopediatric Home Monitoring Tool","OSCAR","Inclusion Criteria:\n\n* Patients aged between 0 and 36 months inclusive\n* With a congenital heart defect\n* Underwent cardiac surgery at Nantes University Hospital\n* Affiliated to a social security scheme\n* Free, informed and written consent of the 2 holders of parental authority\n\nNon Inclusion Criteria:\n\n* Clinical or family situation contraindicating a return home\n* Physical inability to connect to the Exolis platform at home\n* Insufficient understanding on the part of those with parental authority\n* Extracardiac co-morbidities responsible for organ failure requiring repeated\n* Hospitalisation for non-cardiovascular reasons (e.g. severe renal failure, neurological neurological deficit, complex immune deficiency, etc).\n* Patient and\u002For parents under legal protection","ALL","0 Minutes","36 Months",{"count":67,"type":68},186,"ESTIMATED","INTERVENTIONAL",[71],"NA","We hypothesize that a home monitoring program combined with routine postoperative care significantly reduces morbidity and mortality after neonatal and pediatric cardiac surgery. This project differs from the previously published experiences by (a) providing an innovative telemedicine solution via the use of validated measurement sensors, (b) an alert system based on individualized standards, established for each care pathway, and (c) a protocolized response from medical teams in the management of alerts generated by the home monitoring tool.",[74],"Congenital Heart Defect",[76],"Congenital heart defects, cardiac surgery, care pathway, home monitoring, morbidity and mortality","2026-06-23",{"date":79,"type":80},"2026-06-25","ACTUAL",{"date":82,"type":80},"2025-10-30",{"date":84,"type":68},"2028-07-30",{"name":5,"class":6},1]