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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) Indiana University School of Medicine |
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Information provided by: | National Center for Research Resources (NCRR) |
ClinicalTrials.gov Identifier: | NCT00006272 |
OBJECTIVES:
I. Compare the total daily energy expenditure in infants with ventricular septal defects vs healthy control infants.
Condition |
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Heart Septal Defects, Ventricular |
Study Type: | Observational |
Study Design: | Natural History |
Official Title: | Study of Energy Expenditure in Infants With Ventricular Septal Defects |
Estimated Enrollment: | 20 |
Study Start Date: | August 1994 |
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.
Ages Eligible for Study: | 3 Months to 4 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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
United States, Indiana | |
Indiana University | Recruiting |
Indianapolis, Indiana, United States, 46202-5167 | |
Contact: Catherine A. Leitch 317-274-4920 |
Study Chair: | Catherine A. Leitch | Indiana University |
Study ID Numbers: | NCRR-M01RR00750-9045, IU-9607-08, IU-9511-16 |
Study First Received: | September 11, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00006272 |
Health Authority: | United States: Federal Government |
cardiovascular and respiratory diseases heart defects rare disease |
Heart Septal Defects Heart Diseases Congenital heart septum defect Cardiovascular Abnormalities Heart Septal Defects, Ventricular |
Respiration Disorders Rare Diseases Ventricular septal defects Congenital Abnormalities Heart Defects, Congenital |
Cardiovascular Diseases |