Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease

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).

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease; Nutritional Failure
• Intervention / Treatment: Other: CHD

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Infants with Single Ventricle Congenital Heart Disease (CHD) being treated at CCHMC and Healthy newborns recruited from CCHMC and private practices

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	at newborn hospitalization (at 1-5 days)

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Jeffrey Anderson, MD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: March 11, 2013
• First Submitted That Met QC Criteria: March 26, 2013
• First Posted (Estimate): April 1, 2013

Study Record Updates

• Last Update Posted (Estimate): April 14, 2014
• Last Update Submitted That Met QC Criteria: April 11, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital; Univentricular Heart
• Other Study ID Numbers: 2010-0638