- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006272
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment
Contacts and Locations
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202-5167
- Recruiting
- Indiana University
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Contact:
- Catherine A. Leitch
- Phone Number: 317-274-4920
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Catherine A. Leitch, Indiana University
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCRR-M01RR00750-9045
- IU-9607-08
- IU-9511-16
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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