Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease

Congenital Heart Disease Clinical Trial

Official title:

Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01821287
• Other study ID #: 2010-0638
• Status: Completed
• Phase: N/A
• First received: March 11, 2013
• Last updated: April 11, 2014
• Start date: September 2010
• Est. completion date: October 2013

Study information

• Verified date: April 2014
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Nutritional Failure

Intervention

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

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The relationship between biochemical markers of nutrition (prealbumin, IGF-1, IGFBP-3, IL6, IL8, TNF-a, 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)	No
Primary	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	No
Secondary	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	No