Bronchiolitis, ViralNCT00122785
Single Injection of Dexamethasone for Acute Bronchiolitis in Young Children
A study testing dexamethasone in people with Bronchiolitis, Viral, run by Khon Kaen University at 1 site in Thailand.
Trial 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 more about this study
- Who is it for?
- Ages 4 weeks to 24 months
- Conditions the study is for
- Bronchiolitis, Viral
- What is being tested?
- dexamethasone
- How many people
- 170 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2002to Sep 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Underlying congenital heart disease or immunodeficiency
- Receives treatment of any form of corticosteroids within 2 weeks
- Has contraindication to corticosteroid treatment
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Srinagarind Hospital, Khon Kaen University and Khon Kaen Hospital, Ministry of Public Health
Khon Kaen, Changwat Khon Kaen, 40002
About this 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
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.
- Conditions
- Bronchiolitis, Viral
- Being tested
- dexamethasone
- Keywords
- bronchiolitis, wheezing, dexamethasone, young children
- Medical subject headings
- Bronchiolitis, Viral, Bronchiolitis, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startApr 2002
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis, ViralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 170 participants
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council of Thailand
- Investigators
- Jamaree Teeratakulpisarn, M.D., Principal investigator, Faculty of Medicine, Khon Kaen University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122785
- Sponsor's protocol ID
- HE44243
- Status last verified
- Feb 2005
- First submitted
- 18 Jul 2005
- Last updated
- 29 Jul 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00122785
- Acronym / sponsor ID
- HE44243
- Conditions
- Bronchiolitis, Viral
- Keywords
- bronchiolitis, wheezing, dexamethasone, young children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Collaborators
- National Research Council of Thailand
- Study start
- Apr 2002
- Study completion
- Sep 2004
- First posted
- 22 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 4 weeks to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasone | Drug | – |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamaree Teeratakulpisarn, M.D. principal investigator
Faculty of Medicine, Khon Kaen University, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexamethasone in people with Bronchiolitis, Viral, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time from study entry to respiratory distress resolved, which was defined as the following: respiratory rate score of 0 or 1. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2005.