[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592811":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":31,"responsibleParty":60,"collaborators":19,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":19,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":89,"whyStopped":19,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University Hospital, Bordeaux","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Blue-Line programme","EXPERIMENTAL","Telemonitoring program",[13],"Other: Blue-Line home telemonitoring program",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Blue-Line home telemonitoring program","* A dedicated telemonitoring team with nurses and pediatric cardiologist\n* A dedicated therapeutic patient education programme\n* A home telemonitoring medical device with a dedicated platform",[9],null,[21,27],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"Mélissa DACCORD","CONTACT","+33 5 24 54 91 68","+33","melissa.daccord@chu-bordeaux.fr",{"name":28,"role":23,"phone":29,"phoneExt":25,"email":30},"Julie CHABANEIX, MD","+33 5 57 65 61 09","julie.thomas@chu-bordeaux.fr",[32,49],{"facility":33,"status":19,"city":34,"state":35,"zip":36,"country":35,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"CHU de Montpellier - Hôpital Arnaud de Villeneuve","Montpellier","France","34295 - Cedex 5","FR",{"type":39,"coordinates":40},"Point",[41,42],3.87635,43.61093,{"lat":42,"lon":41},[45],{"name":46,"role":23,"phone":47,"phoneExt":25,"email":48},"Marie VINCENTI, MD","+33 4 67 33 66 43","m-vincenti@chu-montpellier.fr",{"facility":50,"status":19,"city":51,"state":35,"zip":52,"country":35,"countryCode":37,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque","Pessac","33604",{"type":39,"coordinates":54},[55,56],-0.6324,44.80565,{"lat":56,"lon":55},[59],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":26},{"type":61,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100592811","feasibility-of-home-telemonitoring-of-infants-with-congenital-heart-disease-awaiting-surgery-during-the-first-year-of-life-100592811",false,"NCT06998290","Feasibility of Home Telemonitoring of Infants With Congenital Heart Disease Awaiting Surgery During the First Year of Life","Feasibility of Home Telemonitoring of Infants With Congenital Heart Disease Awaiting Surgery During the First Year of Life: the Blue-Line Pilot Study","Blue-Line","Inclusion Criteria:\n\n* Newborns and\u002For infants aged 0 to 12 months inclusive at the time of diagnosis.\n* With congenital heart disease as defined in the ICD-11 classification.\n* Waiting for an intervention by cardiac surgery or interventional catheterization.\n* Free, informed consent signed by the holder(s) of parental authority.\n* Person affiliated to or benefiting from a social security scheme.\n\nExclusion Criteria:\n\n* Short-term vital prognosis\n* Clinical situation identified at the M3C RCP that contraindicates a return home\n* Family situation identified at the M3C RCP as contra-indicating a return home\n* Extra-cardiac co-morbidities requiring hospitalisation independent of the heart disease (e.g. severe renal failure, neurological deficit, complex immune deficiency, etc.).\n* Limited understanding of parental authority holder(s) \u002F caregivers (non-French speaking, hearing impaired, cognitive impairment or other)\n* Parents unable to give informed consent.\n* Minors with parental authority","ALL","0 Months","12 Months",{"count":74,"type":75},20,"ESTIMATED","INTERVENTIONAL",[78],"NA","Actually, there is no telemonitoring program that includes newborns or infants with congenital heart disease awaiting cardiac intervention. This is a vulnerable period, prone to clinical complications, rehospitalization, parental stress, and requires monitoring with clinical and therapeutic optimization. The aim of the study is to assess the feasibility and acceptability of monitoring newborns and infants with congenital heart disease awaiting cardiac surgery using the Blue-Line home telemonitoring program.",[81],"CHD - Congenital Heart Disease",[83,84,85,86,87,88],"Congenital heart disease","Infants","Vulnerability","Home monitoring","Therapeutic education","Digital platform","NOT_YET_RECRUITING","2025-05-21",{"date":92,"type":93},"2025-05-31","ACTUAL",{"date":95,"type":75},"2025-06-01",{"date":97,"type":75},"2027-06-01",{"name":5,"class":6},2]