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Single Injection of Dexamethasone for Acute Bronchiolitis in Young Children

Efficacy of Single Injection of Dexamethasone for Acute Bronchiolitis in Children Younger Than 2 Years Old: A Randomized, Double-Blind, Placebo Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00122785
Enrollment
170
Registered
2005-07-22
Start date
2002-04-30
Completion date
2004-09-30
Last updated
2005-07-29

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

Conditions

Bronchiolitis, Viral

Keywords

bronchiolitis, wheezing, dexamethasone, young children

Brief summary

The purpose of this study was to determine whether a single intramuscular injection of dexamethasone decreased the duration of symptoms of acute bronchiolitis in young children.

Detailed description

Acute bronchiolitis is an infection of the lower respiratory tract causing inflammation of the small airways, leading to bronchiolar obstruction. Corticosteroids are frequently prescribed as anti-inflammatory drugs. The usefulness of corticosteroids for this disease remains controversial, despite many randomized controlled trials (RCTs). Recently, a meta-analysis and systemic review showed significant improvement in clinical symptoms, length of hospital stay and duration of symptoms in children with this disease after treatment with various regimens of systemic corticosteroids. Dexamethasone is a long acting corticosteroid with biologic half-life ranging from 36-72 hours. A single dose of dexamethasone has been the standard recommendation for the treatment of croup which has a similar pathophysiology without evidence of adverse effects. Furthermore, there is no previous report of this single dosage form of dexamethasone for the treatment of acute bronchiolitis in young children.

Interventions

DRUGdexamethasone

Sponsors

National Research Council of Thailand
CollaboratorOTHER_GOV
Khon Kaen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
4 Weeks to 24 Months
Healthy volunteers
No

Inclusion criteria

* Aged 4 weeks - 24 months * Has the first episode of wheezing within 7 days * Has evidence of viral infection * Requires hospital admission; criteria for admission include one of the following: age \< 3 months; respiratory rate \> 60 breaths/minute for age \< 12 months or 50 breaths/minute for \> or equal to 12 months; oxygen saturation in room air \< 95% and apathy or refuses feeding.

Exclusion criteria

* Initial admission to intensive care unit * Initial requirement for endotracheal intubation or mechanical ventilation * A previous history of intubation * A known history of asthma or response to the first dose of beta2 agonist nebulization * A history of prematurity * A history of bronchopulmonary dysplasia or chronic lung disease * Underlying congenital heart disease or immunodeficiency * Receives treatment of any form of corticosteroids within 2 weeks * Has contraindication to corticosteroid treatment

Design outcomes

Primary

MeasureTime frame
The time from study entry to respiratory distress resolved, which was defined as the following: respiratory rate score of 0 or 1
wheezing score of 0 or 1
retraction muscle score of 0 or 1
and oxygen saturation greater than or equal to 95% without oxygen

Secondary

MeasureTime frame
The duration of oxygen therapy
Adverse drug events
The length of hospital stay
Additional drugs used
Emergency visit and hospital readmission within one month after discharge

Countries

Thailand

Outcome results

None listed

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