Study of Energy Requirements in Critically Ill Newborns

This study is currently recruiting participants.

Verified by National Center for Research Resources (NCRR), December 2003

First Received: September 11, 2000 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	Indiana University School of Medicine
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00006274

Purpose

OBJECTIVES:

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

Condition
Respiratory Distress Syndrome

Study Type:	Observational
Study Design:	Natural History
Official Title:	Study of Energy Requirements in Critically Ill Newborns

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment:	60
Study Start Date:	March 1997

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.

Eligibility

Ages Eligible for Study:	up to 120 Hours
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006274

Locations

United States, Indiana
Indiana University	Recruiting
Indianapolis, Indiana, United States, 46202-5167
Contact: Catherine A. Leitch 317-274-4920

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Indiana University School of Medicine

Investigators

Study Chair:

Catherine A. Leitch

Indiana University

More Information

No publications provided

Study ID Numbers:	NCRR-M01RR00750-9044, IU-9703-22
Study First Received:	September 11, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00006274 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):

cardiovascular and respiratory diseases
neonatal disorders
rare disease
respiratory distress syndrome

Additional relevant MeSH terms:

Disease Attributes
Disease
Pathologic Processes
Respiratory Tract Diseases
Critical Illness

Lung Diseases
Syndrome
Respiration Disorders
Respiratory Distress Syndrome, Adult

ClinicalTrials.gov processed this record on February 08, 2010