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Home > "S" Clinical Trials Conditions > Study of Energy Expenditure in Infants With Ventricular Septal Defects  Study of Energy Expenditure in Infants With Ventricular Septal Defects
Study of Energy Expenditure in Infants With Ventricular Septal Defects
For Condition: Heart Septal Defects, Ventricular
Status: Recruiting
Sponsor(s): National Center for Research Resources (NCRR) , Indiana University
Synopsis: OBJECTIVES: I. Compare the total daily energy expenditure in infants with ventricular septal defects vs healthy control infants.
Details: 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 3 Months/4 Months
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 20
Location and Contact Information:
Overall Study Official:
CatherineLeitch, Study Chair, Indiana University
Indiana University *Recruiting*
Indianapolis, Indiana, 46202-5167
United States
Recruiting Catherine Leitch 317-274-4920
Additional Information:
Study ID Numbers: NCRR-M01RR00750-9045; IU-9607-08,IU-9511-16
Study Start Date: August 1994
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006272
Other Heart Septal Defects, Ventricular Studies:
1. Infant Heart Surgery: Central Nervous System Sequelae of Circulatory Arrest
2. Reproduction and Survival After Cardiac Defect Repair
3. Study of Energy Expenditure in Infants With Ventricular Septal Defects
Related Studies:
Other Heart Septal Defects, Ventricular Clinical Trials
Other Indiana Clinical Trials
Other Indianapolis Clinical Trials
Study of Energy Expenditure in Infants With Ventricular Septal Defects
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