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 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT02184169
Eligibility Criteria:
Inclusion Criteria:
1. Patients from birth to 6 months of age
2. HLHS AND no prior operations AND planned S1P or HPOR d-TGA/IVS AND planned ASO
3. Written parental informed consent
Exclusion Criteria:
1. Weight \< 2 kg
2. Disease specific A. HLHS patients: Infants whose surgical plan includes a neonatal biventricularrepair will be excluded.
B. d-TGA/IVS patients: Newborns with any additional cardiac defect other than an atrial septal defect will be excluded.
3. Patients on ECMO preoperatively
4. Clinically significant tracheo-esophageal fistula or known preoperative air leak
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
6 Months
Study:
NCT02184169
Study Brief:
Protocol Section:
NCT02184169