Single Dose Versus Multiple Doses of Dexamethasone in Children With Acute Bronchiolitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2006-04-30

Brief Summary

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This study is to determine the effectiveness of five-day treatment versus a single dose of oral dexamethasone (corticosteroid) in children between 2 and 24 months of age with a first episode of acute bronchiolitis presenting in the Emergency Department

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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

DOUBLE

Interventions

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dexamethasone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* infants 2 to 24 months of age
* acute bronchiolitis, defined as first episode of wheezing with upper respiratory infection and respiratory distress
* moderate to severe baseline disease severity (Respiratory Distress Index (RDAI) score 6 to 15)
* only patients discharged at or shortly after 240 minutes of uniform stabilization therapy will be randomized

Exclusion Criteria

* previous wheezing and/or bronchodilator therapy
* hospitalization at 240 minutes
* critically ill patients needing airway stabilization
* patients with low or very high baseline disease severity (RDAI \<5 and \>16)
* patients under 8 weeks of age
* patients on corticosteroids prior to arrival at Emergency Department
* contact with varicella within 21 days
* past history of ventilation for greater than 24 hours
* existing cardiopulmonary disease, multisystem disease or immunodeficiency
* insufficient command of the English language

Minimum Eligible Age

2 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No