Bronchiolitis, ViralPhase 4NCT00119002
The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis
A Phase 4 study testing dexamethasone in people with Bronchiolitis, Viral, run by University of Utah at 1 site in United States.
Trial summary
This study will compare a single dose of oral dexamethasone to placebo in a multicenter, randomized, double blind trial of infants aged 2 to 12 months with first-time bronchiolitis (defined as wheezing within 7 days of onset). This is given as additional therapy beyond any other routine therapy used at that center. Read more about this study
- Who is it for?
- Ages 2 to 11 months
- Conditions the study is for
- Bronchiolitis, Viral
- What is being tested?
- dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 598 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Apr 2006
- Phase
- Phase 4
- 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 11 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- First attack of wheezing within 7 days of onset
- Age 2 months through 11 months (less than 12 months)
- Disease of at least moderate severity (RDAI score greater than or equal to 6)
Who cannot join
- Prior adverse reaction to dexamethasone
- Known heart or lung disease
- Premature birth prior to 36 weeks' gestation
- History of prior asthma or bronchodilator use
- Immune suppression or deficiency
- Trisomy 21
Show all 11Show fewer
- Critical or life-threatening complications of bronchiolitis
- Treatment with corticosteroids within 14 days
- Known active chickenpox
- Exposure to chickenpox within 21 days
- Child sent to ED for automatic admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Primary Children's Medical Center
Salt Lake City, Utah, 84158-0249
About this study
Official title: The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis: A Multicenter Randomized Controlled Trial
This study will compare a single dose of oral dexamethasone to placebo in a multicenter, randomized, double blind trial of infants aged 2 to 12 months with first-time bronchiolitis (defined as wheezing within 7 days of onset). This is given as additional therapy beyond any other routine therapy used at that center. No current standard therapy is withheld, and no additional tests or other treatments are part of the study.The primary hypothesis is that dexamethasone will be more effective than placebo in preventing hospital admission. The secondary hypotheses are that dexamethasone will decrease respiratory scores and possibly the duration of the disease when compared to placebo, and that dexamethasone will be as safe and as well tolerated as placebo.
Read the detailed description
Bronchiolitis is the most common lower respiratory infection in infants, and the respiratory condition leading to the most hospital admissions in young children. It is also probably the most common serious illness of childhood lacking evidence-based treatment. Evidence both for and against the effectiveness of corticosteroids such as dexamethasone has been published. Editorials, expert reviews, and a recent report from the Agency for Healthcare Research and Quality recommend a study such as this one.
Patients will be drawn from the emergency departments at participating medical centers in the Pediatric Emergency Care Applied Research Network, created by the Emergency Medical Services for Children program and the Maternal and Child Health Bureau of the Health Resources and Services Administration to study health problems of high acuity and high incidence in children.
Comparisons: The primary outcome (hospital admission after 4 hours of ED observation) and secondary outcomes will be compared between treatment and placebo groups.
- Conditions
- Bronchiolitis, Viral
- Being tested
- dexamethasone, Placebo
- Keywords
- randomized clinical trial, placebo-controlled, double-blind, double-masked, infant, dexamethasone, wheezing
- Medical subject headings
- Bronchiolitis, Viral, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
1mg/kg dexamethasone
PlaceboDrug
1mg/kg placebo
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | 1mg of Dexamethasone/kg Receives: Drug: dexamethasone |
| Placebo | Placebo comparator | 1mg/kg placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital admission after 4 hours of ED observation
Measured: 4 hours
Secondary outcomes (3)
Severity of disease measured by respiratory (RDAI) scores, vital signs, and oximetry.
Measured: 4 hours
Duration of hospitalization (if admitted) measured at 7-to-10 day followup.
Measured: 7-10 days
Safety, toleration, and parental satisfaction measured at 7-to-10 day followup.
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2005 (estimated)
- Study startJan 2004
- 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 Bronchiolitis, ViralStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Children's Hospital of Michigan, Children's Hospital Medical Center, Cincinnati, Washington University School of Medicine, Columbia University, Children's National Research Institute, Helen DeVos Children's Hospital, Women & Children's Hospital of Buffalo, University of Rochester, NYU Langone Health, Hurley Medical Center, Boston Children's Hospital, University of Maryland, Johns Hopkins University, Howard County General Hospital, University of California, Davis
- Investigators
- Howard Corneli, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119002
- Sponsor's protocol ID
- R40MC04298-01-00
- Status last verified
- Jan 2008
- First submitted
- 1 Jul 2005
- Last updated
- 14 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Corneli HM, Zorc JJ, Mahajan P, Shaw KN, Holubkov R, Reeves SD, Ruddy RM, Malik B, Nelson KA, Bregstein JS, Brown KM, Denenberg MN, Lillis KA, Cimpello LB, Tsung JW, Borgialli DA, Baskin MN, Teshome G, Goldstein MA, Monroe D, Dean JM, Kuppermann N; Bronchiolitis Study Group of the Pediatric Emergency Care Applied Research Network (PECARN). A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis. N Engl J Med. 2007 Jul 26;357(4):331-9. doi: 10.1056/NEJMoa071255.
PubMed 17652648
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00119002
- Acronym / sponsor ID
- R40MC04298-01-00
- Conditions
- Bronchiolitis, Viral
- Keywords
- randomized clinical trial, placebo-controlled, double-blind, double-masked, infant, dexamethasone, wheezing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Children's Hospital of Michigan, Children's Hospital Medical Center, Cincinnati, Washington University School of Medicine, Columbia University, Children's National Research Institute, Helen DeVos Children's Hospital, Women & Children's Hospital of Buffalo, University of Rochester, NYU Langone Health, Hurley Medical Center, Boston Children's Hospital, University of Maryland, Johns Hopkins University, Howard County General Hospital, University of California, Davis
- Study start
- Jan 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 12 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.
This study will compare a single dose of oral dexamethasone to placebo in a multicenter, randomized, double blind trial of infants aged 2 to 12 months with first-time bronchiolitis (defined as wheezing within 7 days of onset). This is given as additional therapy beyond any other routine therapy used at that center. No current standard therapy is withheld, and no additional tests or other treatments are part of the study.The primary hypothesis is that dexamethasone will be more effective than placebo in preventing hospital admission. The secondary hypotheses are that dexamethasone will decrease respiratory scores and possibly the duration of the disease when compared to placebo, and that dexamethasone will be as safe and as well tolerated as placebo.
Detailed description
Bronchiolitis is the most common lower respiratory infection in infants, and the respiratory condition leading to the most hospital admissions in young children. It is also probably the most common serious illness of childhood lacking evidence-based treatment. Evidence both for and against the effectiveness of corticosteroids such as dexamethasone has been published. Editorials, expert reviews, and a recent report from the Agency for Healthcare Research and Quality recommend a study such as this one.
Patients will be drawn from the emergency departments at participating medical centers in the Pediatric Emergency Care Applied Research Network, created by the Emergency Medical Services for Children program and the Maternal and Child Health Bureau of the Health Resources and Services Administration to study health problems of high acuity and high incidence in children.
Comparisons: The primary outcome (hospital admission after 4 hours of ED observation) and secondary outcomes will be compared between treatment and placebo groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: dexamethasone1mg of Dexamethasone/kg |
| Placebo | Placebo comparator | Drug: Placebo1mg/kg placebo |
Who may qualify
- Ages
- 2 to 11 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- First attack of wheezing within 7 days of onset
- Age 2 months through 11 months (less than 12 months)
- Disease of at least moderate severity (RDAI score greater than or equal to 6)
Key exclusion criteria (11 listed)
- Prior adverse reaction to dexamethasone
- Known heart or lung disease
- Premature birth prior to 36 weeks' gestation
- History of prior asthma or bronchodilator use
- Immune suppression or deficiency
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 |
|---|---|---|
| dexamethasone1mg/kg dexamethasone | Drug | Dexamethasone |
| Placebo1mg/kg placebo | Drug | Placebo |
Primary outcome
Hospital admission after 4 hours of ED observation
Time frame: 4 hours
3 secondary outcomes
Severity of disease measured by respiratory (RDAI) scores, vital signs, and oximetry.
Time frame: 4 hours
Duration of hospitalization (if admitted) measured at 7-to-10 day followup.
Time frame: 7-10 days
Safety, toleration, and parental satisfaction measured at 7-to-10 day followup.
Time frame: 7-10 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 14 Mar 2008.
- Results publication: PubMed 17652648Corneli HM, Zorc JJ, Mahajan P, Shaw KN, Holubkov R, Reeves SD, Ruddy RM, Malik B, Nelson KA, Bregstein JS, Brown KM, Denenberg MN, Lillis KA, Cimpello LB, Tsung JW, Borgialli DA, Baskin MN, Teshome G, Goldstein MA, Monroe D, Dean JM, Kuppermann N; Bronchiolitis Study Group of the Pediatric Emergency Care Applied Research Network (PECARN). A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis. N Engl J Med. 2007 Jul 26;357(4):331-9. doi: 10.1056/NEJMoa071255.
- Pediatric Emergency Care Applied Research Network (PECARN)Link provided by the sponsor.
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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.
Howard Corneli, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexamethasone in people with Bronchiolitis, Viral, run by University of Utah at 1 site in United States.
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 3 inclusion and 11 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 14 Mar 2008. 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 United States. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Hospital admission after 4 hours of ED observation (time frame: 4 hours). 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 NCT00119002, 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 14 Mar 2008.