Study of Energy Requirements in Critically Ill Newborns
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|ClinicalTrials.gov Identifier: NCT00006274|
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
I. Determine the total energy expenditure in term and preterm infants in both well and ill states using the doubly labeled water method.
|Condition or disease|
|Respiratory Distress Syndrome|
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.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Observational Model:||Natural History|
|Official Title:||Study of Energy Requirements in Critically Ill Newborns|
|Study Start Date :||March 1997|
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): NCT00006274
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202-5167|
|Contact: Catherine A. Leitch 317-274-4920|
|Study Chair:||Catherine A. Leitch||Indiana University|