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NCT07019857

Impact of Thymectomy on Immunity in Infants After Cardiac Surgery

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

Summary

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 undergoing heart surgery with partial thymectomy; * 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. By 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. Participation 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.

Official title: Impact of Thymectomy on Immune Response in Infants 12 Months After Cardiac Surgery: a Single-centre Prospective Study

Key Details

Gender

All

Age Range

Any - 6 Months

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-09-01

Completion Date

2027-12-01

Last Updated

2025-06-18

Healthy Volunteers

Conditions

Congenital Heart Defects Thymectomy Immunological Deficiency Syndrome

Interventions

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: * Blood cell count * TREC dosage * Complete Lymphocytes immunophenotyping * Immunoglobulin dosage

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.

Locations (1)

CHU de Nantes

Nantes, France