Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006274
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-09-11
Brief Title:
Study of Energy Requirements in Critically Ill Newborns
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
Study of Energy Requirements in Critically Ill Newborns
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 Determine the total energy expenditure in term and preterm infants in both well and ill states using the doubly labeled water method
I Determine the total energy expenditure in term and preterm infants in both well and ill states using the doubly labeled water method
Detailed Description:
PROTOCOL OUTLINE Patients are assigned to one of three groups according to gestational age 24-28 weeks estimated gestational age EGA vs 29-34 weeks EGA vs 35 weeks EGA and over and severity of respiratory illness need for high frequency ventilation vs stable conventional ventilator settings or extubated within past 24 hours vs no need for mechanical ventilation
Patients receive water labeled with deuterium and oxygen O 18 by mouth or by gastrostomy tube on days 1 and 7 Urine samples are collected prior to the first dose 4-6 hours after the first dose and then every 24 hours until the second dose All urine is collected for 4-6 hours after the second dose Samples are analyzed by dual inlet isotope ratio mass spectrometry
Patients receive water labeled with deuterium and oxygen O 18 by mouth or by gastrostomy tube on days 1 and 7 Urine samples are collected prior to the first dose 4-6 hours after the first dose and then every 24 hours until the second dose All urine is collected for 4-6 hours after the second dose Samples are analyzed by dual inlet isotope ratio mass spectrometry
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-9703-22 | None | None | None |