Intestinal Function in Neonates With Complex Congenital Heart Disease
Completed · Not applicable
Conditions studied: Congenital Heart Defects, Growth Failure
In brief
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 - through a collaborative effort between pediatric cardiology, cardiothoracic surgery, neonatology, microbiology, and immunology. The hypothesis is that term neonates with complex congenital heart disease (CHD) who receive trophic breastmilk feeds in the pre-operative period will show improved gut function than neonates who were strictly NPO (nothing by mouth) in the pre-operative period.
Key facts
- Study ID
- NCT01475357
- Run by
- Medical University of South Carolina
- People needed
- 27
- Starts
- 2011-10-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2014-10-15
Who can join
Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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