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:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-25 @ 2:58 AM
NCT ID:
NCT00932633
Eligibility Criteria:
Inclusion Criteria:
* Term or near-term (\> 35 week gestation) neonates with CHD presenting for cardiac surgery
* Less than 30 days old
* 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 will be excluded from participation
* Newborns with either genetic syndromes or congenital infections that are associated with developmental delay will also be excluded
* Newborns with perinatal depression as defined by a cord blood gas pH \< 7.0 or a 5 minute Apgar score \< 5, will be excluded
* Patients with multiple organ failure, syndromes, and perinatal depression have other causes for neurodevelopmental abnormalities
* Those patients unable to return for postoperative follow-up and neurodevelopmental testing will also be excluded from participation
* Parent or legal guardian unable or unwilling to consent
* Non-English speaking families
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
30 Days
Study:
NCT00932633
Study Brief:
Protocol Section:
NCT00932633