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Single Injection of Dexamethasone for Acute Bronchiolitis in Young Children

Primary Purpose

Bronchiolitis, Viral

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
dexamethasone
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis, Viral focused on measuring bronchiolitis, wheezing, dexamethasone, young children

Eligibility Criteria

4 Weeks - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
July 18, 2005
Last Updated
July 28, 2005
Sponsor
Khon Kaen University
Collaborators
National Research Council of Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT00122785
Brief Title
Single Injection of Dexamethasone for Acute Bronchiolitis in Young Children
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2005
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Khon Kaen University
Collaborators
National Research Council of Thailand

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis, Viral
Keywords
bronchiolitis, wheezing, dexamethasone, young children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
170 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
dexamethasone
Primary Outcome Measure Information:
Title
The time from study entry to respiratory distress resolved, which was defined as the following: respiratory rate score of 0 or 1
Title
wheezing score of 0 or 1
Title
retraction muscle score of 0 or 1
Title
and oxygen saturation greater than or equal to 95% without oxygen
Secondary Outcome Measure Information:
Title
The duration of oxygen therapy
Title
The length of hospital stay
Title
Additional drugs used
Title
Emergency visit and hospital readmission within one month after discharge
Title
Adverse drug events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamaree Teeratakulpisarn, M.D.
Organizational Affiliation
Faculty of Medicine, Khon Kaen University, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Srinagarind Hospital, Khon Kaen University and Khon Kaen Hospital, Ministry of Public Health
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

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Single Injection of Dexamethasone for Acute Bronchiolitis in Young Children

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