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Study of Energy Requirements in Critically Ill Newborns
This study is currently recruiting participants.
Study NCT00006274   Information provided by National Center for Research Resources (NCRR)
First Received: September 11, 2000   Last Updated: June 23, 2005   History of Changes

September 11, 2000
June 23, 2005
March 1997
 
 
 
Complete list of historical versions of study NCT00006274 on ClinicalTrials.gov Archive Site
 
 
 
Study of Energy Requirements in Critically Ill Newborns
Study of Energy Requirements in Critically Ill Newborns

OBJECTIVES:

I. Determine the total energy expenditure in term and preterm infants in both well and ill states using the doubly labeled water method.

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.

 
Observational
Natural History
Respiratory Distress Syndrome
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
60
 
 

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Infants with estimated gestational age (EGA) of at least 24 weeks with respiratory illness who are on high frequency ventilation (HFOV) and meet the following conditions: Appropriate size for gestational age (AGA) No congenital anomalies No medical complications, including seizures and necrotizing enterocolitis

OR

Control infants with EGA of at least 24 weeks Must meet 1 of the following conditions: Requirement for stable conventional ventilator settings with respiratory index score of less than 2.5 and/or extubated within past 24 hours No requirement for mechanical ventilation Must meet all of the following conditions: AGA No congenital anomalies No medical complications, including seizures and necrotizing enterocolitis No documented sepsis by positive blood culture No supplemental oxygen use (infants 35 weeks EGA and over only)

--Prior/Concurrent Therapy--

HFOV group: Concurrent surfactant, theophylline, or inotrope (vasopressor) therapy allowed

Control group: No concurrent inotrope (vasopressor) therapy

Both
up to 120 Hours
Yes
 
United States
 
NCT00006274
 
NCRR-M01RR00750-9044, IU-9703-22
National Center for Research Resources (NCRR)
Indiana University School of Medicine
Study Chair: Catherine A. Leitch Indiana University
National Center for Research Resources (NCRR)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP