Completed
Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease
What is being collected
Data Collection
Collected from today forward - ProspectiveOtherDNA Samples
Who is being recruted
Congenital Abnormalities+3
+ Cardiovascular Diseases
+ Heart Diseases
Until 12 Months
+4 Eligibility Criteria
How is the trial designed
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Observational
Study Start: September 2010
Summary
Principal SponsorChildren's Hospital Medical Center, Cincinnati
Last updated: April 14, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2010
Actual date on which the first participant was enrolled.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).
Principal SponsorChildren's Hospital Medical Center, Cincinnati
Last updated: April 14, 2014
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
75 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Until 12 Months
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Congenital AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCardiovascular AbnormalitiesHeart Defects, Congenital
Criteria
2 inclusion criteria required to participate
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
2 exclusion criteria prevent from participating
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Cincinnati Children's Hospital Medical Center
Cincinnati, United StatesOpen Cincinnati Children's Hospital Medical Center in Google MapsCompletedOne Study Center