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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT04151160
Eligibility Criteria:
Case Subjects:
Inclusion Criteria:
* Age less than or equal to 12 months old at the time of enrollment
* Known hemodynamically significant congenital heart disease
* Undergoing surgery, with or without cardiopulmonary bypass, to repair or palliate their congenital heart defect
Exclusion Criteria:
* Known renal dysfunction
* Prematurity less than 36 weeks corrected gestational age
Control Subjects:
Inclusion Criteria:
* Age less than or equal to 12 months old at the time of enrollment
* No known heart disease OR presence of only non-hemodynamically significant congenital heart disease, including: tiny muscular ventricular septal defect, patent foramen ovale, peripheral pulmonary stenosis, normally functioning bicuspid aortic valve (no stenosis and no more than trivial insufficiency), and tiny patent ductus arteriosus
Exclusion Criteria:
* History of hemodynamically significant congenital heart disease
* History of surgery with general anesthesia
* Known renal dysfunction
* Prematurity less than 36 weeks corrected gestational age
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
0 Days
Maximum Age:
12 Months
Study:
NCT04151160
Study Brief:
Protocol Section:
NCT04151160