Impact of Thymectomy on Immunity in Infants After Cardiac Surgery

Launched by NANTES UNIVERSITY HOSPITAL · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial, called the THYMIC study, is looking at how different types of thymus removal during heart surgery affect the immune system of infants with congenital heart defects. The thymus is an important gland that helps the body build its immune defenses, especially in young children. The study aims to find out if partially removing the thymus (partial thymectomy) during heart surgery might help preserve immune function better than completely removing it (complete thymectomy). Researchers will compare the immune responses and infection rates in infants who undergo these different types of surgery.

To participate in the study, infants must be between 0 and 6 months old, born at a healthy gestational age, and scheduled for cardiac surgery at Nantes University Hospital. Parents will need to provide written consent for their child to take part. All participating infants will undergo a couple of blood tests—one during surgery and another a year later—to measure their immune cells and responses. It's important to note that joining this study won’t change the medical care their child will receive; the surgeon will decide on the type of thymus removal based on the child’s specific needs.

Gender

ALL

Eligibility criteria

• 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.