Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease

Study Overview
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Brief Summary
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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).

Official Title
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Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease

Conditions
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Congenital Heart Disease, Nutritional Failure

Intervention / Treatment
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* Other: CHD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CHD Infants<br>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 | Other: CHD<br>* The study is not providing an intervention but rather is observational/studying factors that could contribute to nutritional failure in single ventricle CHD infants<br>|
| Normal Controls<br>Healthy newborns (full-term infants with no known medical problems) recruited from Cincinnati Children's Hospital Medical Center (CCHMC) and private practices | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting Energy Expenditure (REE) for infants with a single ventricle compared to the age-matched control infants using the analysis of covariance procedure | The following covariates will be considered for inclusion in the model: cardiac diagnoses, measures of cardiac function, hemodynamic measurements, number of parents, and number of siblings living at home. Transformations of REE (e.g. log or rank) may be conducted to satisfy the assumptions of the analysis. | At 12 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between REE and weight changes in infants with a single ventricle and control subjects; measures include REE, weight, and z-score (weight for age) | Will be estimated by Pearson's correlation coefficient. If the assumption of normality of the two measurements is not reasonable, Spearman's rank correlation will be conducted. To further explore the relationship between REE and weight gain in infants with a single ventricle, partial correlation coefficients will be estimated where the following covariates are considered for inclusion in the model: cardiac diagnoses, measures of cardiac function, number of parents, and number of siblings living at home. | At 12 months of age |