Recruiting

Observational Study

Sponsor:

National Center for Research Resources (NCRR)

Code:

NCT00006274

Conditions

Respiratory Distress Syndrome

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Respiratory Distress Syndrome

Study ID

NCT00006274

Start date

Mar, 1997

Status verified date

Dec, 2003

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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

Enrollment

60 participants

Interventions and Outcome Measures

Central Contacts and Locations

Locations

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202-5167

Contacts

Catherine A. Leitch

317-274-4920

More Information

Sponsor

National Center for Research Resources (NCRR)

Last update posted

Jun 24, 2005

Last verified

Dec, 2003

Keywords

  • cardiovascular and respiratory diseases
  • neonatal disorders
  • rare disease
  • respiratory distress syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Center for Research Resources (NCRR) on 2005-06-24.