Study of Energy Requirements in Critically Ill Newborns
Recruitment status was: Recruiting
I. Determine the total energy expenditure in term and preterm infants in both well and ill states using the doubly labeled water method.
|Respiratory Distress Syndrome|
|Study Design:||Observational Model: Natural History|
|Official Title:||Study of Energy Requirements in Critically Ill Newborns|
|Study Start Date:||March 1997|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006274
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202-5167|
|Contact: Catherine A. Leitch 317-274-4920|
|Study Chair:||Catherine A. Leitch||Indiana University|