Single Injection of Dexamethasone for Acute Bronchiolitis in Young Children

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

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2004-09-30

Brief Summary

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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

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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.

Conditions

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Bronchiolitis, Viral

Keywords

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bronchiolitis wheezing dexamethasone young children

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

* 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

Minimum Eligible Age

4 Weeks

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jamaree Teeratakulpisarn, M.D.

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Khon Kaen University, Thailand

Locations

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Srinagarind Hospital, Khon Kaen University and Khon Kaen Hospital, Ministry of Public Health

Khon Kaen, Changwat Khon Kaen, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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HE44243

Identifier Type: -

Identifier Source: org_study_id