Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease

Completed

• Conditions: Congenital Heart Disease; Nutritional Failure
• Interventions: Other: CHD

• Registration Number: NCT01821287
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-04-01
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-11
• Last Update Posted: 2014-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CHD Infants	CHD	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

Primary Outcome Measures

Name	Time	Method
Resting Energy Expenditure (REE) for infants with a single ventricle compared to the age-matched control infants using the analysis of covariance procedure	At 12 months of age	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.

Secondary Outcome Measures

Name	Time	Method
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)	At 12 months of 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.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States