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 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT02320669
Eligibility Criteria:
Inclusion Criteria:
1. Informed consent obtained
2. Male and female patients \<5 months (152 days) of age
3. Patients undergoing cardiopulmonary bypass
Exclusion Criteria:
1. Known thyroid disease (Down Syndrome is not an exclusion criterion unless patient has thyroid disease)
2. Trisomy 13 and 18
3. Prolonged preoperative ventilator support which would not be impacted by cardiac surgery (Lung disease: bronchopulmonary dysplasia, hypoplastic lungs associated with diaphragmatic hernia)
4. Any other condition as determined by the PI causing prolonged ventilator support which is unlikely to respond favorably to cardiac surgery
5. Prior participation in the clinical trial
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
5 Months
Study:
NCT02320669
Study Brief:
Protocol Section:
NCT02320669