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Impact of Thymectomy on Immunity in Infants After Cardiac Surgery

RecruitingNAAges any - 6 MonthsAllNantes University Hospital
NCT07019857 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. The 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. This is a prospective, interventional, single-center study conducted at CHU de Nantes, involving 3 groups of infants: * One group undergoing heart surgery with complete thymectomy; * One group undergo

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📋 Eligibility rules (as published)
Inclusion Criteria: * \- Children aged between 0 and 6 months; * Born at a gestational age \> 37 weeks' gestation; * With an indication for cardiac surgery under CEC at Nantes University Hospital; * Cardiopediatric follow-up planned at Nantes University Hospital; * Written agreement signed by legal guardians to participate in the study. For the control groups: * Control group A (cardiac surgery without thymectomy): * Children aged between 0 and 6 months of age; * Born at a gestational age \> 37 SA; * Indicated for thoracotomy cardiac surgery at Nantes University Hospital; * Cardiopediatric follow-up planned at Nantes University Hospital; * Written agreement signed by legal guardians to participate in the study. * Control group B (non-cardiac surgery) * Children aged between 0 and 6 months; * Born at a gestational age \> 37 SA; * Indicated for non-cardiac surgery (ENT or visceral surgery at Nantes University Hospital); * Planned follow-up surgery at Nantes University Hospital; * Written agreement signed by legal guardians to participate in the study. Exclusion Criteria : * Gestational age \< 37 SA; * With a history of cardiac surgery under ECG; * And/or with heart disease requiring further surgery within 12 months of the 1st surgery (e.g. pulmonary cerclage, systemic pulmonary anastomosis). * And/or a history of partial or complete thymectomy; * Receiving long-term immunosuppressive treatment; * Post-operative follow-up planned in a hospital other than Nantes University Hospital, or moving house planned during the follow-up period; * parental refusal. Exclusion Criteria: * \- Gestational age \< 37 SA; * With a history of cardiac surgery under ECG; * And/or with heart disease requiring further surgery within 12 months of the 1st surgery (e.g. pulmonary cerclage, systemic pulmonary anastomosis). * And/or a history of partial or complete thymectomy; * Receiving long-term immunosuppressive treatment; * Post-operative follow-up planned in a hospital other than Nantes University Hospital, or moving house planned during the follow-up period; * parental refusal.
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What it tests

  • Blood sample collection at surgery time and 12 months later
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Where

2 sites
CHU de Nantes
Nantes, France
Chu de Nantes
Nantes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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