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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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heliox

heliox-driven nebulizations for children with moderate to severe bronchiolitis

Group Type OTHER

heliox

Intervention Type DRUG

continuous heliox therapy

oxygen

oxygen-driven nebulizations for children with moderate to severe bronchiolitis

Group Type OTHER

oxygen

Intervention Type DRUG

continuous oxygen therapy

Interventions

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heliox

continuous heliox therapy

Intervention Type DRUG

oxygen

continuous oxygen therapy

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes