OBJECTIVES:

I. Compare the total daily energy expenditure in infants with ventricular septal defects vs healthy control infants.

Condition
Heart Septal Defects, Ventricular

Further Study Details: 

Expected Total Enrollment:  20

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   -   4 Months,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Indiana
      Indiana University, Indianapolis,  Indiana,  46202-5167,  United States; Recruiting

Study chairs or principal investigators

Catherine A. Leitch,  Study Chair,  Indiana University   

Study ID Numbers:  NCRR-M01RR00750-9045; IU-9607-08; IU-9511-16
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  September 11, 2000
ClinicalTrials.gov Identifier:  NCT00006272
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08