An observational study in Heart Septal Defects, Ventricular, sponsored by National Center for Research Resources (NCRR). Status unknown at 1 site in United States. Open to participants aged 3 Months to 4 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2005-06-24.
Sponsored by National Center for Research Resources (NCRR) · Observational
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.
82 studies on the registry are indexed under Heart Septal Defects; 9 are open to participants now.
This study's enrollment of 20 is below the median of 75 across 24 observational studies indexed under Heart Septal Defects.
Browse Heart Septal Defects studies →National Center for Research Resources (NCRR) is the lead sponsor of 265 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
This study is status unknown, as verified in Dec 2003. You cannot join it, but the record below documents what was studied.
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National Center for Research Resources (NCRR)