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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 11, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | August 1994 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00006272 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Energy Expenditure in Infants With Ventricular Septal Defects | ||||
| Official Title ICMJE | Study of Energy Expenditure in Infants With Ventricular Septal Defects | ||||
| Brief Summary | OBJECTIVES: I. Compare the total daily energy expenditure in infants with ventricular septal defects vs healthy control infants. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Natural History | ||||
| Condition ICMJE | Heart Septal Defects, Ventricular | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 3 Months to 4 Months | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00006272 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | NCRR-M01RR00750-9045, IU-9607-08, IU-9511-16 | ||||
| Study Sponsor ICMJE | National Center for Research Resources (NCRR) | ||||
| Collaborators ICMJE | Indiana University School of Medicine | ||||
| Investigators ICMJE |
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| Information Provided By | National Center for Research Resources (NCRR) | ||||
| Verification Date | December 2003 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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