BronchiolitisPhase 3NCT00213226
Single Dose Versus Multiple Doses of Dexamethasone in Children With Acute Bronchiolitis
A Phase 3 study testing dexamethasone in people with Bronchiolitis, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
This study is to determine the effectiveness of five-day treatment versus a single dose of oral dexamethasone (corticosteroid) in children between 2 and 24 months of age with a first episode of acute bronchiolitis presenting in the Emergency Department Read more about this study
- Who is it for?
- Ages 2 to 24 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- dexamethasone
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2001to Apr 2006
- Phase
- Phase 3
- 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 2 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants 2 to 24 months of age
- acute bronchiolitis, defined as first episode of wheezing with upper respiratory infection and respiratory distress
- moderate to severe baseline disease severity (Respiratory Distress Index (RDAI) score 6 to 15)
- only patients discharged at or shortly after 240 minutes of uniform stabilization therapy will be randomized
Who cannot join
- previous wheezing and/or bronchodilator therapy
- hospitalization at 240 minutes
- critically ill patients needing airway stabilization
- patients with low or very high baseline disease severity (RDAI <5 and >16)
- patients under 8 weeks of age
- patients on corticosteroids prior to arrival at Emergency Department
Show all 10Show fewer
- contact with varicella within 21 days
- past history of ventilation for greater than 24 hours
- existing cardiopulmonary disease, multisystem disease or immunodeficiency
- insufficient command of the English language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Single Dose Versus Multiple Doses of Dexamethasone in Outpatients With Acute Bronchiolitis
This study is to determine the effectiveness of five-day treatment versus a single dose of oral dexamethasone (corticosteroid) in children between 2 and 24 months of age with a first episode of acute bronchiolitis presenting in the Emergency Department
- Conditions
- Bronchiolitis
- Being tested
- dexamethasone
- Keywords
- bronchiolitis, pediatrics, corticosteroids
- Medical subject headings
- Bronchiolitis
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.
Proportion of patients stabilized, discharged and subsequently hospitalized and/or co-interventions with corticosteroids or beta2 agonists outside the protocol within the 6 day study period
Secondary outcomes (4)
Respiratory Assessment Change Score (RACS) at 96 and 144 hours
Proportion of infants with unscheduled medical visits for respiratory distress within the 6 day study period
Proportion of infants with no signs of respiratory distress at 96 and 144 hours
Proportion of infants who are symptomatic at 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2001
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Suzanne Schuh, The Hospital for Sick Children
- Investigators
- Suzanne Schuh, MD, Principal investigator, The Hospital for Sick Children, Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213226
- Sponsor's protocol ID
- 0020010349
- Status last verified
- May 2014
- First submitted
- 13 Sep 2005
- Last updated
- 13 May 2014
- Results posted
- No
Publications
Schuh S, Coates AL, Dick P, Stephens D, Lalani A, Nicota E, Mokanski M, Khaikin S, Allen U. A single versus multiple doses of dexamethasone in infants wheezing for the first time. Pediatr Pulmonol. 2008 Sep;43(9):844-50. doi: 10.1002/ppul.20845.
PubMed 18668692
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Single Dose Versus Multiple Doses of Dexamethasone in Outpatients With Acute Bronchiolitis
- ClinicalTrials.gov ID
- NCT00213226
- Acronym / sponsor ID
- 0020010349
- Conditions
- Bronchiolitis
- Keywords
- bronchiolitis, pediatrics, corticosteroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Dec 2001
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 21 Sep 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.
This study is to determine the effectiveness of five-day treatment versus a single dose of oral dexamethasone (corticosteroid) in children between 2 and 24 months of age with a first episode of acute bronchiolitis presenting in the Emergency Department
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 2 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- infants 2 to 24 months of age
- acute bronchiolitis, defined as first episode of wheezing with upper respiratory infection and respiratory distress
- moderate to severe baseline disease severity (Respiratory Distress Index (RDAI) score 6 to 15)
- only patients discharged at or shortly after 240 minutes of uniform stabilization therapy will be randomized
Key exclusion criteria (10 listed)
- previous wheezing and/or bronchodilator therapy
- hospitalization at 240 minutes
- critically ill patients needing airway stabilization
- patients with low or very high baseline disease severity (RDAI <5 and >16)
- patients under 8 weeks of age
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
Proportion of patients stabilized, discharged and subsequently hospitalized and/or co-interventions with corticosteroids or beta2 agonists outside the protocol within the 6 day study period
4 secondary outcomes
Respiratory Assessment Change Score (RACS) at 96 and 144 hours
Proportion of infants with unscheduled medical visits for respiratory distress within the 6 day study period
Proportion of infants with no signs of respiratory distress at 96 and 144 hours
Proportion of infants who are symptomatic at 14 days
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 13 May 2014.
- Results publication: PubMed 18668692Schuh S, Coates AL, Dick P, Stephens D, Lalani A, Nicota E, Mokanski M, Khaikin S, Allen U. A single versus multiple doses of dexamethasone in infants wheezing for the first time. Pediatr Pulmonol. 2008 Sep;43(9):844-50. doi: 10.1002/ppul.20845.
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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.
Suzanne Schuh, MD principal investigator
The Hospital for Sick Children, Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dexamethasone in people with Bronchiolitis, run by The Hospital for Sick Children at 1 site in Canada.
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 10 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 13 May 2014. 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 Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportion of patients stabilized, discharged and subsequently hospitalized and/or co-interventions with corticosteroids or beta2 agonists outside the protocol within the 6 day study period. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00213226, which also lists 1 linked publication.
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 13 May 2014.