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

Efficacy of Single Dose Versus Multiple Doses of Dexamethasone in Outpatients With Acute Bronchiolitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00213226

Enrollment

120

Registered

2005-09-21

Start date

2001-12-31

Completion date

2006-04-30

Last updated

2014-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis

Keywords

bronchiolitis, pediatrics, corticosteroids

Brief summary

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

Interventions

DRUGdexamethasone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

2 Months to 24 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Proportion of patients stabilized, discharged and subsequently hospitalized and/or co-interventions with corticosteroids or beta2 agonists outside the protocol within the 6 day study period	—

Secondary

Measure	Time frame
Respiratory Assessment Change Score (RACS) at 96 and 144 hours	—
Proportion of infants with unscheduled medical visits for respiratory distress within the 6 day study period	—
Proportion of infants with no signs of respiratory distress at 96 and 144 hours	—
Proportion of infants who are symptomatic at 14 days	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026