Status:
COMPLETED
Intestinal Function in Neonates With Complex Congenital Heart Disease
Lead Sponsor:
Medical University of South Carolina
Conditions:
Congenital Heart Defects
Growth Failure
Eligibility:
All Genders
37-40 years
Phase:
NA
Brief Summary
Postnatal intestinal function in cardiac infants. The overall goal of this proposal is to address a widespread health problem in the pediatric cardiac infant population - poor postnatal growth - throu...
Detailed Description
The overall goal of this proposal is to address a widespread health problem in the pediatric cardiac infant population - poor postnatal growth - through a collaborative effort between pediatric cardio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01475357
Start Date
October 1 2011
End Date
April 1 2014
Last Update
October 15 2014
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425