Study of Energy Expenditure in Infants With Ventricular Septal Defects
NCT ID: NCT00006272
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
1994-08-31
Brief Summary
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I. Compare the total daily energy expenditure in infants with ventricular septal defects vs healthy control infants.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NATURAL_HISTORY
Eligibility Criteria
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Inclusion 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
3 Months
4 Months
ALL
Yes
Sponsors
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Indiana University School of Medicine
OTHER
National Center for Research Resources (NCRR)
NIH
Principal Investigators
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Catherine A. Leitch
Role: STUDY_CHAIR
Indiana University
Locations
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Indiana University
Indianapolis, Indiana, United States
Countries
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Facility Contacts
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Catherine A. Leitch
Role: primary
Other Identifiers
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IU-9607-08
Identifier Type: -
Identifier Source: secondary_id
IU-9511-16
Identifier Type: -
Identifier Source: secondary_id
NCRR-M01RR00750-9045
Identifier Type: -
Identifier Source: org_study_id