Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease
NCT ID: NCT01821287
Last Updated: 2014-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
75 participants
OBSERVATIONAL
2010-09-30
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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CHD Infants
Infants with a single ventricle (Congenital Heart Disease) CHD admitted to Cincinnati Children's Hospital Medical Center (CCHMC) for neonatal medical management or surgical palliation
CHD
The study is not providing an intervention but rather is observational/studying factors that could contribute to nutritional failure in single ventricle CHD infants
Normal Controls
Healthy newborns (full-term infants with no known medical problems) recruited from Cincinnati Children's Hospital Medical Center (CCHMC) and private practices
No interventions assigned to this group
Interventions
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CHD
The study is not providing an intervention but rather is observational/studying factors that could contribute to nutritional failure in single ventricle CHD infants
Eligibility Criteria
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Inclusion Criteria
* Normal controls: Healthy newborns (full-term infants with no known medical problems) recruited from CCHMC and private practices.
Exclusion Criteria
* Normal controls: 1) Premature birth (\<36 weeks), 2) Chromosomal abnormalities, 3) Major gastrointestinal, pulmonary or neurologic anomalies., 4) Cardiovascular anomalies
12 Months
ALL
Yes
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Anderson, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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2010-0638
Identifier Type: -
Identifier Source: org_study_id
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