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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| Normal Controls | Healthy newborns (full-term infants with no known medical problems) recruited from Cincinnati Children's Hospital Medical Center (CCHMC) and private practices |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHD | Other | The study is not providing an intervention but rather is observational/studying factors that could contribute to nutritional failure in single ventricle CHD infants |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The relationship between biochemical markers of nutrition (prealbumin, IGF-1, IGFBP-3, IL6, IL8, TNF-α, cortisol, insulin, and lymphocyte subclasses) and weight changes in infants with a single ventricle | Will be estimated by Pearson's correlation coefficient. If the assumption of normality of the measurements is not reasonable, Spearman's rank correlation will be conducted. To further explore the relationship between biochemical markers of nutrition and weight gain, 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. Finally, a regression model will be created using weight gain (and weight-for-age Z-scores) as the dependent variable and candidate independent variables including cardiac diagnoses, measures of cardiac function, hemodynamic measurements, REE, number of parents living at home, and number of siblings living at home |
Inclusion Criteria:
Exclusion Criteria:
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Infants with Single Ventricle Congenital Heart Disease (CHD) being treated at CCHMC and Healthy newborns recruited from CCHMC and private practices
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Anderson, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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whole blood
| At 12 months of age |
| at newborn hospitalization (at 1-5 days) |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |