Status:
COMPLETED
Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Congenital Heart Disease
Nutritional Failure
Eligibility:
All Genders
Up to 12 years
Brief Summary
The purpose of this study is to understand the causes of growth failure and to define biochemical markers of nutritional failure in patients with single ventricle Congenital Heart Disease (CHD).
Eligibility Criteria
Inclusion
- CHD infants: Infants with a single ventricle CHD admitted to CCHMC for neonatal medical management or surgical palliation
- Normal controls: Healthy newborns (full-term infants with no known medical problems) recruited from CCHMC and private practices.
Exclusion
- CHD infants: 1) Premature birth (\<36 weeks), 2) Chromosomal abnormalities, 3) Major gastrointestinal, pulmonary or neurologic anomalies
- Normal controls: 1) Premature birth (\<36 weeks), 2) Chromosomal abnormalities, 3) Major gastrointestinal, pulmonary or neurologic anomalies., 4) Cardiovascular anomalies
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01821287
Start Date
September 1 2010
End Date
October 1 2013
Last Update
April 14 2014
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229