Study of Energy Expenditure in Infants With Ventricular Septal Defects
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|ClinicalTrials.gov Identifier: NCT00006272|
Recruitment Status : Unknown
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was: Recruiting
First Posted : September 12, 2000
Last Update Posted : June 24, 2005
I. Compare the total daily energy expenditure in infants with ventricular septal defects vs healthy control infants.
|Condition or disease|
|Heart Septal Defects, Ventricular|
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.
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Observational Model:||Natural History|
|Official Title:||Study of Energy Expenditure in Infants With Ventricular Septal Defects|
|Study Start Date :||August 1994|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006272
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202-5167|
|Contact: Catherine A. Leitch 317-274-4920|
|Study Chair:||Catherine A. Leitch||Indiana University|