CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 72 enrolled
Drug / intervention
heliox +1 moredrug
Likely dose
Heliox-driven continuous nebulized racemic epinephrine (specific dose not stated)AI-extracted
Key inclusion· 3
  • Age 2–12 months presenting to emergency department
  • Moderate-to-severe bronchiolitis with Modified Wood's Clinical Bronchiolitis Score >3
  • Clinical bronchiolitis features: tachypnea, cough, prolonged expiratory phase, wheezing, rales, chest retractions, hyperinflation on imaging
Key exclusion· 15
  • Age <2 months or >12 months
  • Cyanotic heart disease
  • Lobar pneumonia on chest radiograph
  • Croup

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00116584
NCT00116584Phase 3Completed

The Use of Heliox Driven Racemic Epinephrine Nebulization in the Treatment of Moderate to Severe Bronchiolitis in Pediatric Emergency Department Patients

University of Louisville·interventional·Posted Jun 30, 2005·Updated May 20, 2020

In Brief

A Phase 3 clinical trial evaluating heliox and oxygen for Bronchiolitis. Completed, enrolled 72 participants across 1 site.

Detailed Summary

The purpose of this study is to assess whether children with moderate to severe bronchiolitis treated with standard racemic epinephrine therapy via 70:30 helium-oxygen (heliox) driven nebulization will have improvements in measurements of airway more rapidly than those treated with conventional air-oxygen driven nebulization.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBronchiolitis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 30, 2005
Enrollment StartDec 1, 2004
Primary CompletionMar 1, 2008
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 21.0 years ago

Interventions

helioxdrug

continuous heliox therapy

oxygendrug

continuous oxygen therapy