Full Text View
Tabular View
No Study Results Posted
Related Studies
Study of Energy Expenditure in Infants With Ventricular Septal Defects
This study is currently recruiting participants.
Study NCT00006272   Information provided by National Center for Research Resources (NCRR)
First Received: September 11, 2000   Last Updated: June 23, 2005   History of Changes

September 11, 2000
June 23, 2005
August 1994
 
 
 
Complete list of historical versions of study NCT00006272 on ClinicalTrials.gov Archive Site
 
 
 
Study of Energy Expenditure in Infants With Ventricular Septal Defects
Study of Energy Expenditure in Infants With Ventricular Septal Defects

OBJECTIVES:

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

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.

 
Observational
Natural History
Heart Septal Defects, Ventricular
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
20
 
 

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

Both
3 Months to 4 Months
Yes
 
United States
 
NCT00006272
 
NCRR-M01RR00750-9045, IU-9607-08, IU-9511-16
National Center for Research Resources (NCRR)
Indiana University School of Medicine
Study Chair: Catherine A. Leitch Indiana University
National Center for Research Resources (NCRR)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP