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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT01475357
Eligibility Criteria:
Inclusion Criteria:
* Study subjects will be male and female neonates admitted to MUSC PCICU or NICU prior to 72 hours of life who are gestational age ≥ 37 weeks.
* inpatient status at MUSC for a minimum of 48 hours prior to planned surgery and have a postnatal diagnosis of complex congenital heart disease - defined as a structural heart defect requiring cardiac surgery (reparative or palliative) prior to hospital discharge.
Exclusion Criteria:
* Infants with hemodynamic instability in the pre-operative period requiring mechanical circulatory support or
* who have the presence of lactate \> 3 after the first 24 hours of admission
* admission from home
* major congenital extracardiac abnormalities (i.e. renal, brain, GI)
* cardiac surgery will not be performed at MUSC, and
* mother does not plan to pump breastmilk during the infant's first week of life.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
37 Weeks
Maximum Age:
40 Weeks
Study:
NCT01475357
Study Brief:
Protocol Section:
NCT01475357