Heart Septal Defects, Ventricular Clinical Trial
Official title:
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.
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Observational Model: Natural History
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