We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Energy Requirements in Critically Ill Newborns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Collaborator:
Information provided by:

Study Description
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.


Condition or disease
Respiratory Distress Syndrome

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.


Study Design

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


Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 120 Hours   (Child)
Sexes Eligible for Study:   All
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

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

Contacts and Locations

Information from the National Library of Medicine

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


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

ClinicalTrials.gov Identifier: NCT00006274     History of Changes
Other Study ID Numbers: NCRR-M01RR00750-9044
IU-9703-22
First Posted: September 12, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2003

Keywords provided by National Center for Research Resources (NCRR):
cardiovascular and respiratory diseases
neonatal disorders
rare disease
respiratory distress syndrome

Additional relevant MeSH terms:
Critical Illness
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Disease Attributes
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases