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 @ 1:30 PM
Ignite Modification Date:
2025-12-24 @ 1:30 PM
NCT ID:
NCT00490295
Eligibility Criteria:
Inclusion Criteria:
* Ten consecutive full-term (\>36 week gestation) neonates, one day to 30 days of age, presenting for cardiac surgery for arterial switch operation or Norwood operation will be eligible for the study.
* No patient will be excluded because of race or ethnicity.
* Parental or legal guardian consent will be obtained for all patients prior to enrollment.
Exclusion Criteria:
* Newborns with multiple organ abnormalities in addition to their heart defect such as diaphragmatic hernia, tracheo-esophageal fistula, and congenital syndromes involving multiple organs will be excluded from participation.
* Newborns with genetic syndromes associated with developmental delay will also be excluded.
* Newborns with birth asphyxia, 5 minute Apgar score \< 5, will be excluded. Patients with multiple organ failure, syndromes, and birth asphyxia have other causes for neurodevelopmental abnormalities.
* Those patients unable to return for postop follow-up and neurodevelopmental testing will be excluded from participation.
* Those patients with parents/guardians who are unable to read or speak English will be excluded from participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
30 Days
Study:
NCT00490295
Study Brief:
Protocol Section:
NCT00490295