Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT07019857
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.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
6 Months
Study:
NCT07019857
Study Brief:
Protocol Section:
NCT07019857