Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006272
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-09-11
Brief Title:
Study of Energy Expenditure in Infants With Ventricular Septal Defects
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
Study of Energy Expenditure in Infants With Ventricular Septal Defects
Status:
UNKNOWN
Status Verified Date:
2003-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES
I Compare the total daily energy expenditure in infants with ventricular septal defects vs healthy control infants
I Compare the total daily energy expenditure in infants with ventricular septal defects vs healthy control infants
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 pulmonarysystemic blood flow ratio and pulmonary artery pressures
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 pulmonarysystemic blood flow ratio and pulmonary artery pressures
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IU-9511-16 | None | None | None |
| IU-9607-08 | None | None | None |