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CompletedNCT00122785Updated Jul 29, 2005

Single Injection of Dexamethasone for Acute Bronchiolitis in Young Children

An interventional study of dexamethasone in Bronchiolitis, Viral, sponsored by Khon Kaen University. Completed at 1 site in Thailand. Open to participants aged 4 Weeks to 24 Months. Per ClinicalTrials.gov, last updated 2005-07-29.

Sponsored by Khon Kaen University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
4 Weeks to 24 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bronchiolitis, Viral

Keywords

  • bronchiolitis
  • wheezing
  • dexamethasone
  • young children
03

In context

Bronchiolitis, Viral

30 studies on the registry are indexed under Bronchiolitis, Viral; 2 are open to participants now.

This study's enrollment of 170 is above the median of 85 across 25 interventional studies indexed under Bronchiolitis, Viral.

Browse Bronchiolitis, Viral studies →

Lead sponsor

Khon Kaen University is the lead sponsor of 161 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Weeks to 24 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 within 2 weeks
  • Has to corticosteroid treatment
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
170 participants

Interventions

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Srinagarind Hospital, Khon Kaen University and Khon Kaen Hospital, Ministry of Public Health
    Khon Kaen, 40002, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00122785
Collaborators
National Research Council of Thailand
First posted
Jul 22, 2005
Start date
Apr 2002
Completion
Sep 2004
Last update
Jul 29, 2005

Study contacts

Jamaree Teeratakulpisarn, M.D.
principal investigator · Faculty of Medicine, Khon Kaen University, Thailand
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2005. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Dexamethasone

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