Clinical Trial: Study of Energy Expenditure in Infants With Ventricular Septal Defects

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Observational

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

Brief Summary:

OBJECTIVES:

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

Detailed Summary:

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.

Sponsor: National Center for Research Resources (NCRR)

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Center for Research Resources (NCRR)

Dates:
Date Received: September 11, 2000
Date Started: August 1994
Date Completion:
Last Updated: June 23, 2005
Last Verified: December 2003