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Single Injection of Dexamethasone for Acute Bronchiolitis in Young Children

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ClinicalTrials.gov Identifier: NCT00122785
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : July 29, 2005
Sponsor:
Collaborator:
National Research Council of Thailand
Information provided by:
Khon Kaen University

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.

Condition or disease Intervention/treatment Phase
Bronchiolitis, Viral Drug: dexamethasone Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : April 2002
Study Completion Date : September 2004

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Primary Outcome Measures :
  1. The time from study entry to respiratory distress resolved, which was defined as the following: respiratory rate score of 0 or 1
  2. wheezing score of 0 or 1
  3. retraction muscle score of 0 or 1
  4. and oxygen saturation greater than or equal to 95% without oxygen

Secondary Outcome Measures :
  1. The duration of oxygen therapy
  2. The length of hospital stay
  3. Additional drugs used
  4. Emergency visit and hospital readmission within one month after discharge
  5. Adverse drug events


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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00122785     History of Changes
Other Study ID Numbers: HE44243
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: July 29, 2005
Last Verified: February 2005

Keywords provided by Khon Kaen University:
bronchiolitis
wheezing
dexamethasone
young children

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis, Viral
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action