Status:
COMPLETED
Heliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients
Lead Sponsor:
University of Louisville
Conditions:
Bronchiolitis
Eligibility:
All Genders
2-12 years
Phase:
PHASE3
Brief 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 wil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00116584
Start Date
December 1 2004
End Date
October 1 2011
Last Update
May 20 2020
Active Locations (1)
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1
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202