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 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT01749059
Eligibility Criteria:
Inclusion Criteria:
1. Documentation of informed consent and authorization.
2. Full term and late preterm newborns (EGA 35-44 weeks)
3. On room air
4. Neonates known to have a congenital heart defect at the time of screening, e.g., antenatal diagnosis or diagnosis within the first 24 hours after birth
5. Parents agree to follow-up contact post discharge
Exclusion Criteria:
1. On supplemental oxygen
2. Admitted to the Neonatal Intensive Care Unit
3. Parents do not agree to follow-up
4. Greater than 30 days of age
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
30 Days
Study:
NCT01749059
Study Brief:
Protocol Section:
NCT01749059