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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT03558269
Eligibility Criteria:
Inclusion Criteria:
1. At least 35 weeks of gestation
2. Prenatal diagnosis of HLHS including mitral stenosis/atresia, aortic stenosis/atresia, arch hypoplasia and the presence of hypoplastic left ventricle with or without VSD.
3. Norwood procedure will take place within 14 days from birth.
4. Treatment with cord blood should be given within 7 days after surgery.
5. Parental informed consent for collection of umbilical cord blood.
Exclusion Criteria:
1. Total nucleated cells (TNC) lower than 1X107 in the collected umbilical cord blood unit.
2. Infected umbilical cord blood unit.
3. Parents refusal to continue in the study at any stage.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Days
Maximum Age:
14 Days
Study:
NCT03558269
Study Brief:
Protocol Section:
NCT03558269