Phase 3
N=72
Heliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients
Bronchiolitis
Bottom Line
View on ClinicalTrials.gov: NCT00116584 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes — 1.84; .031 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- heliox (Drug); oxygen (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Louisville
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes |
1.84; .031 | <0.05 sig |
| SECONDARY Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times |
-0.33; 0; 0.54; 0; 0.77; 0 | <0.05 sig |
| SECONDARY Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times |
-0.48; 0; 1.80; 0; 2.92; 0 | <0.05 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Any child 2-12 months old seen in the emergency department.
- A clinical bronchiolitis score > 3 by modified Wood's Clinical Bronchiolitis Score (M-WCBS).
- Diagnostic criteria of bronchiolitis includes tachypnea, cough, prolonged expiratory phase, wheezing, rales, chest retractions, and hyperinflation of lungs on chest radiograph. After consenting a patient to the study, respiratory syncytial virus (RSV) infection will be tested by rapid enzyme-linked immunoabsorbent assay of nasal secretions.
Exclusion Criteria
- No child will be excluded based on race or gender
- Patients under the age of 2 months or greater than 12 months
- Patients with cyanotic heart disease
- Patients with lobar pneumonia, defined by results of chest radiographs.
- The presence of interstitial disease or diffuse patchy marking consistent with atelectasis on chest radiographs will not exclude patients.
- Patients with croup.
- Patients with foreign body aspiration.
- Patients with history of cystic fibrosis, bronchopulmonary dysplasia or other chronic lung disease.
- Patients with liver or renal disease.
- Patients with sickle cell anemia.
- Patients requiring mechanical ventilation.
- Patients who develop supraventricular tachycardia secondary to racemic epinephrine administration.
- Patients with tracheomalacia or bronchomalacia.
- Patients who had received bronchodilators within 2 hours of initiation of the study.
- Patients who had received systemic corticosteroids within 72 hours of enrollment
- Patients who suffered from persistent airway hyperreactivity in the 3 months before the study.
- Patients who do not tolerate the nasal cannulae for 45 out of 60 minutes.
Data sourced from ClinicalTrials.gov (NCT00116584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.