Single Injection of Dexamethasone for Acute Bronchiolitis in Young Children

Bronchiolitis, Viral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00122785
• Other study ID #: HE44243
• Status: Completed
• Phase: N/A
• First received: July 18, 2005
• Last updated: July 28, 2005
• Start date: April 2002
• Est. completion date: September 2004

Study information

• Verified date: February 2005
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis, Viral

Intervention

Drug:
• dexamethasone

Locations

Country	Name	City	State
Thailand	Srinagarind Hospital, Khon Kaen University and Khon Kaen Hospital, Ministry of Public Health	Khon Kaen

Sponsors (2)

Lead Sponsor	Collaborator
Khon Kaen University	National Research Council of Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time from study entry to respiratory distress resolved, which was defined as the following: respiratory rate score of 0 or 1
Primary	wheezing score of 0 or 1
Primary	retraction muscle score of 0 or 1
Primary	and oxygen saturation greater than or equal to 95% without oxygen
Secondary	The duration of oxygen therapy
Secondary	The length of hospital stay
Secondary	Additional drugs used
Secondary	Emergency visit and hospital readmission within one month after discharge
Secondary	Adverse drug events