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Single Injection of Dexamethasone for Acute Bronchiolitis in Young Children

This study has been completed.
Sponsor:
Collaborator:
National Research Council of Thailand
Information provided by:
Khon Kaen University
ClinicalTrials.gov Identifier:
NCT00122785
First received: July 18, 2005
Last updated: July 28, 2005
Last verified: February 2005
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

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

No publications provided

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

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
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
 Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013