Study of Energy Expenditure in Infants With Ventricular Septal Defects



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:4/2/2016
Start Date:August 1994

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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.

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
We found this trial at
1
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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