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Study of Energy Expenditure in Infants With Ventricular Septal Defects

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ClinicalTrials.gov Identifier: NCT00006272
Recruitment Status : Unknown
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was:  Recruiting
First Posted : September 12, 2000
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

OBJECTIVES:

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


Condition or disease
Heart Septal Defects, Ventricular

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 Design

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Natural History
Official Title: Study of Energy Expenditure in Infants With Ventricular Septal Defects
Study Start Date : August 1994

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006272


Locations
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202-5167
Contact: Catherine A. Leitch    317-274-4920      
Sponsors and Collaborators
National Center for Research Resources (NCRR)
Indiana University School of Medicine
Investigators
Study Chair: Catherine A. Leitch Indiana University
More Information

ClinicalTrials.gov Identifier: NCT00006272     History of Changes
Other Study ID Numbers: NCRR-M01RR00750-9045
IU-9607-08
IU-9511-16
First Posted: September 12, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2003

Keywords provided by National Center for Research Resources (NCRR):
cardiovascular and respiratory diseases
heart defects
rare disease

Additional relevant MeSH terms:
Heart Septal Defects
Heart Septal Defects, Ventricular
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities