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NCT00006274 Clinical Trial

Study of Energy Requirements in Critically Ill Newborns

Respiratory Distress Syndrome Clinical Trial

Official title:
Study of Energy Requirements in Critically Ill Newborns

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00006274
Other study ID # NCRR-M01RR00750-9044
Secondary ID IU-9703-22
Status Recruiting
Phase N/A
First received September 11, 2000
Last updated June 23, 2005
Start date March 1997

Study information
Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 120 Hours
Eligibility 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

Study Design

Observational Model: Natural History

Related Conditions & MeSH terms

Locations
Country Name City State
United States Indiana University Indianapolis Indiana

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

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