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NCT00006272 Clinical Trial

Study of Energy Expenditure in Infants With Ventricular Septal Defects

Heart Septal Defects, Ventricular Clinical Trial

Official title:
Study of Energy Expenditure in Infants With Ventricular Septal Defects

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00006272
Other study ID # NCRR-M01RR00750-9045
Secondary ID IU-9607-08IU-951
Status Recruiting
Phase N/A
First received September 11, 2000
Last updated June 23, 2005
Start date August 1994

Study information
Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

OBJECTIVES:

I. Compare the total daily energy expenditure in infants with ventricular septal defects vs healthy control infants.

Description:

PROTOCOL OUTLINE:

Height, weight, and vital signs (including oxygen saturation by pulse oximetry) are measured on Day 1. Resting energy expenditure, oxygen consumption (VO2), carbon dioxide production (VCO2), and resting respiratory exchange quotient (RQ) are measured using open circuit respiratory calorimetry on Day 1. Patients undergo assessment of total daily energy expenditure using the doubly labeled water method comprised of oral deuterium and oral oxygen O 18 with the next scheduled feeding on Day 1. Urine samples are collected prior to isotope administration, then serially for approximately 12 hours after isotope administration on Day 1, and then daily on Days 2-7. These samples are analyzed by mass spectrometry. On Day 1, patients also undergo echocardiogram to confirm size of defect and measure the degree of pulmonary/systemic blood flow ratio and pulmonary artery pressures.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Months to 4 Months
Eligibility PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Infants with moderate to large ventricular septal defect (VSD) by most recent echocardiogram who meet the following conditions: no other concurrent heart or lung disease; no chromosomal defects or congenital anomalies

OR

Healthy control infants without VSD who meet the following conditions: clinically well; no heart disease; no chromosomal defects or congenital anomalies

--Prior/Concurrent Therapy--

Surgery: VSD infants -- No prior cardiac surgery or palliative procedures; VSD and control infants -- Greater than 6 weeks since other prior surgery

Other: VSD and control infants: Greater than 6 weeks since prior hospitalization

Study Design

Observational Model: Natural History

Related Conditions & MeSH terms

Locations
Country Name City State
United States Indiana University Indianapolis Indiana

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

See also
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Completed NCT00583791 - Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder N/A
Completed NCT00005190 - Reproduction and Survival After Cardiac Defect Repair N/A
Completed NCT00005546 - Molecular Genetic Epidemiology of Three Cardiac Defects -SCOR in Pediatric Cardiovascular Disease N/A
Completed NCT00005322 - Molecular Genetic Epidemiology of Endocardial Cushion Defects - SCOR in Pediatric Cardiovascular Disease N/A
Recruiting NCT00173186 - Aortic Regurgitation After Surgical Repair of Outlet-Type Ventricular Septal Defect N/A
Withdrawn NCT01825369 - Aberrations in Carnitine Homeostasis in Congenital Heart Disease With Increased Pulmonary Blood Flow Phase 1
Completed NCT02361008 - A Randomized Controlled Trial:Treatments on Infundibular Ventricular Septal Defect N/A
Terminated NCT00113698 - Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation Phase 3
Completed NCT00000470 - Infant Heart Surgery: Central Nervous System Sequelae of Circulatory Arrest Phase 3