Heliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients

Completed · Phase 3

Conditions studied: Bronchiolitis

In brief

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.

Key facts

Study ID

NCT00116584

Run by

University of Louisville

People needed

72

Starts

2004-12-01

Expected to finish

2011-10-01

Last updated by the study team

2020-05-20

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Kosair Children's Hospital — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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