Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Nutritional Failure; Congenital Heart Disease

Treatments: Other: CHD

Study type: Observational

Funder types: Other

Identifiers

NCT01821287

2010-0638

Details and patient eligibility

About

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).

Enrollment: 75 patients

Sex: All

Ages: Under 12 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

75 participants in 2 patient groups

CHD Infants

Description:

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

Treatment:

Other: CHD

Normal Controls

Description:

Healthy newborns (full-term infants with no known medical problems) recruited from Cincinnati Children's Hospital Medical Center (CCHMC) and private practices