[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594470":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":30,"centralContacts":34,"locations":42,"responsibleParty":68,"collaborators":29,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":29,"maxAge":79,"enrollmentInfo":80,"targetDuration":29,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":61,"whyStopped":29,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Nantes University Hospital","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Complete Thymectomy Group","EXPERIMENTAL","Infants undergoing cardiac surgery with cardiopulmonary bypass (CPB), during which a complete thymectomy is performed for surgical access to the heart and great vessels. The extent of thymus resection is determined by the cardiac surgeon intraoperatively, based on anatomical considerations",[13],"Diagnostic Test: Blood sample collection at surgery time and 12 months later",{"label":15,"type":10,"description":16,"interventionNames":17},"Partial Thymectomy Group","Infants undergoing cardiac surgery with CPB, during which a partial thymectomy is performed, with an effort to preserve thymic tissue when anatomically feasible.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Control Group (No Thymectomy","ACTIVE_COMPARATOR","Infants undergoing:\n\n* Cardiac surgery by thoracotomy without thymectomy (e.g., for aortic coarctation) or\n* Non-cardiac surgery (e.g., digestive procedures) with complete preservation of the thymus.\n\nThese patients serve as immunological reference controls",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DIAGNOSTIC_TEST","Blood sample collection at surgery time and 12 months later","each participant undergoes a blood test 1) at surgery time and 2) 12 months after surgery. These 5mL samples include:\n\n* Blood cell count\n* TREC dosage\n* Complete Lymphocytes immunophenotyping\n* Immunoglobulin dosage",[9,19,15],null,[31],{"name":32,"affiliation":5,"role":33},"Alexis Chenouard, PH","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":29,"email":38},"CONTACT","02 44 76 82 21","alexis.chenouard@chu-nantes.fr",{"name":40,"role":36,"phone":29,"phoneExt":29,"email":41},"Evelyne Gauvard","Evelyne.GAUVARD@chu-nantes.fr",[43,59],{"facility":44,"status":45,"city":46,"state":29,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"CHU de Nantes","NOT_YET_RECRUITING","Nantes","44093","France","FR",{"type":51,"coordinates":52},"Point",[53,54],-1.55336,47.21725,{"lat":54,"lon":53},[57,58],{"name":32,"role":36,"phone":37,"phoneExt":29,"email":38},{"name":40,"role":36,"phone":29,"phoneExt":29,"email":41},{"facility":60,"status":61,"city":46,"state":29,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Chu de Nantes","RECRUITING",{"type":51,"coordinates":63},[53,54],{"lat":54,"lon":53},[66],{"name":32,"role":36,"phone":67,"phoneExt":29,"email":38},"0244768221",{"type":69,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100594470","impact-of-thymectomy-on-immunity-in-infants-after-cardiac-surgery-100594470",false,"NCT07019857","Impact of Thymectomy on Immunity in Infants After Cardiac Surgery","Impact of Thymectomy on Immune Response in Infants 12 Months After Cardiac Surgery: a Single-centre Prospective Study","THYMIC","Inclusion Criteria:\n\n* \\- Children aged between 0 and 6 months;\n* Born at a gestational age \\> 37 weeks' gestation;\n* With an indication for cardiac surgery under CEC at Nantes University Hospital;\n* Cardiopediatric follow-up planned at Nantes University Hospital;\n* Written agreement signed by legal guardians to participate in the study.\n\nFor the control groups:\n\n* Control group A (cardiac surgery without thymectomy):\n\n  * Children aged between 0 and 6 months of age;\n  * Born at a gestational age \\> 37 SA;\n  * Indicated for thoracotomy cardiac surgery at Nantes University Hospital;\n  * Cardiopediatric follow-up planned at Nantes University Hospital;\n  * Written agreement signed by legal guardians to participate in the study.\n* Control group B (non-cardiac surgery)\n\n  * Children aged between 0 and 6 months;\n  * Born at a gestational age \\> 37 SA;\n  * Indicated for non-cardiac surgery (ENT or visceral surgery at Nantes University Hospital);\n  * Planned follow-up surgery at Nantes University Hospital;\n  * Written agreement signed by legal guardians to participate in the study.\n\nExclusion Criteria :\n\n* Gestational age \\\u003C 37 SA;\n* With a history of cardiac surgery under ECG;\n* And\u002For with heart disease requiring further surgery within 12 months of the 1st surgery (e.g. pulmonary cerclage, systemic pulmonary anastomosis).\n* And\u002For a history of partial or complete thymectomy;\n* Receiving long-term immunosuppressive treatment;\n* Post-operative follow-up planned in a hospital other than Nantes University Hospital, or moving house planned during the follow-up period;\n* parental refusal.\n\nExclusion Criteria:\n\n* \\- Gestational age \\\u003C 37 SA;\n* With a history of cardiac surgery under ECG;\n* And\u002For with heart disease requiring further surgery within 12 months of the 1st surgery (e.g. pulmonary cerclage, systemic pulmonary anastomosis).\n* And\u002For a history of partial or complete thymectomy;\n* Receiving long-term immunosuppressive treatment;\n* Post-operative follow-up planned in a hospital other than Nantes University Hospital, or moving house planned during the follow-up period;\n* parental refusal.","ALL","6 Months",{"count":81,"type":82},70,"ESTIMATED","INTERVENTIONAL",[85],"NA","Heart surgery in infants typically involves complete removal of the thymus gland to improve access to the heart. However, the thymus plays a key role in developing the immune system in early childhood, especially in the production and maturation of T lymphocytes, which help the body defend itself against infections.\n\nThe THYMIC study tests the hypothesis that partial removal of the thymus (partial thymectomy) during heart surgery may better preserve the child's immune function compared to total removal (complete thymectomy). The goal is to determine whether this conservative surgical approach could reduce the risk of immune system impairment and infections in the months following surgery.\n\nThis is a prospective, interventional, single-center study conducted at CHU de Nantes, involving 3 groups of infants:\n\n* One group undergoing heart surgery with complete thymectomy;\n* One group undergoing heart surgery with partial thymectomy;\n* One control group undergoing heart or non-heart surgery without thymus removal. All infants enrolled will have two blood tests: one taken during their surgery and one taken one year later. These blood tests will quantify immune cells (T, B, NK cells), levels of antibodies, and vaccine responses. Parents will also be asked to fill out a questionnaire to record any infections their child experiences during the year after surgery.\n\nBy comparing the immune responses and infection rates among the groups, the researchers hope to better understand the long-term effects of thymectomy in infants. The results could support future recommendations to preserve part of the thymus when possible during heart surgery.\n\nParticipation in the study does not change the medical or surgical care of the child. The decision to perform a partial or complete thymectomy is made by the surgeon based on the child's anatomy. The additional blood samples are small in volume and follow current safety regulations.",[88,89,90],"Congenital Heart Defects","Thymectomy","Immunological Deficiency Syndrome",[89,92,93,94,95,96,97,98],"Cardiac Surgery","Infant","Immunity","Lymphocytes","TRECs","Vaccination","Infection","2026-04-13",{"date":101,"type":102},"2026-04-16","ACTUAL",{"date":104,"type":102},"2025-07-25",{"date":106,"type":82},"2027-12-01",{"name":5,"class":6},2]