Single Injection of Dexamethasone for Acute Bronchiolitis in Young Children - Full Text View

Sponsors and Collaborators:	Khon Kaen University National Research Council of Thailand
Information provided by:	Khon Kaen University
ClinicalTrials.gov Identifier:	NCT00122785

Purpose

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.

Condition	Intervention
Bronchiolitis, Viral	Drug: dexamethasone

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Khon Kaen University:

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

Estimated Enrollment:	170
Study Start Date:	April 2002
Estimated Study Completion Date:	September 2004

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.

Eligibility

Ages Eligible for Study:	up to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122785

Locations

Thailand
Srinagarind Hospital, Khon Kaen University and Khon Kaen Hospital, Ministry of Public Health
Khon Kaen, Thailand, 40002

Sponsors and Collaborators

Khon Kaen University

National Research Council of Thailand

Investigators

Principal Investigator:

Jamaree Teeratakulpisarn, M.D.

Faculty of Medicine, Khon Kaen University, Thailand

More Information

Study ID Numbers:	HE44243
Study First Received:	July 18, 2005
Last Updated:	July 28, 2005
ClinicalTrials.gov Identifier:	NCT00122785
Health Authority:	Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:

bronchiolitis
wheezing
dexamethasone
young children

Study placed in the following topic categories:

Dexamethasone
Virus Diseases
Bronchiolitis, Viral
Lung Diseases, Obstructive
Respiratory Tract Infections

Respiratory Tract Diseases
Lung Diseases
Bronchiolitis
Bronchitis
Dexamethasone acetate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Bronchial Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics

Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009