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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT05914103
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 28 days to 6 years
* Patients awaiting elective cardiac surgery with cardiopulmonary bypass (CPB).
Exclusion Criteria:
* The risk adjustment for congenital heart surgery (RACHS) is above class 5
* Patients with cardiac assist device, mechanical ventilation or the history of asphyxia
* Patients with pulmonary disease, including respiratory tract infections and asthma
* Patients with severe liver or renal dysfunction, including severe acute or chronic renal dysfunction need renal replacement therapy, and acute or chronic liver failure need artificial liver therapy
* Fetal malformation includes polysplenia syndrome, Asplenia Syndrome, Down syndrome, DiGeoge syndrome, Marfan syndrome, trachea-bronchus stricture, diabetes, nervous functioning disorders, genital system malformations, imperforate anus, and Williams syndrome
* Current enrollment in another clinical trial
* Guardian's refusal or low adherence
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
28 Days
Maximum Age:
6 Years
Study:
NCT05914103
Study Brief:
Protocol Section:
NCT05914103