Single Injection of Dexamethasone for Acute Bronchiolitis in Young Children

NCT00122785 | Completed

• 1 other identifier: HE44243
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis, Viral

Keywords

bronchiolitis; wheezing; dexamethasone; young children

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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

Interventions

dexamethasone DRUG

Eligibility Criteria

• Age: 4 Weeks - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead
• National Research Council of Thailand: collaborator

Study Sites (1)

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

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

MeSH Terms

Conditions

Bronchiolitis, Viral; Bronchiolitis; Respiratory Sounds

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Virus Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Jamaree Teeratakulpisarn, M.D.

  Faculty of Medicine, Khon Kaen University, Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 18, 2005
• First Posted: July 22, 2005
• Study Start: April 1, 2002
• Study Completion: September 1, 2004
• Last Updated: July 29, 2005

Record last verified: 2005-02

Locations

TH (1)