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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07327502
Eligibility Criteria:
Inclusion Criteria:
* Child aged over 6 months and under 6 years
* Hospitalized in pediatric cardiac intensive care after cardiac surgery for congenital heart disease.
* Selected congenital heart diseases: ventricular septal defect auricular septal defect, pulmonary stenosis, tetralogy of Fallot
* Surgery with median sternotomy and intraoperative cardiopulmonary bypass
* Intraoperative antibiotic prophylaxis with cefazolin
* Patient affiliated with a social security plan or eligible
* whose two parents or legal guardians have accepted and signed the study consent
Exclusion Criteria:
* Emergency cardiac surgery
* Patient already enrolled in the study
* Patient who has previously undergone cardiac surgery
* Patient with haemostasis disorders or immune deficiency
* Patient with bacterial colonization indicating antibiotic prophylaxis other than cefazolin
* Participation in another interventional research study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
6 Years
Study:
NCT07327502
Study Brief:
Protocol Section:
NCT07327502