Trial of Epinephrine and Albuterol in Bronchiolitis
Primary Purpose
Bronchiolitis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epinephrine
albuterol (salbutamol)
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring Bronchiolitis, disposition, pediatric, epinephrine, albuterol
Eligibility Criteria
Inclusion Criteria: A clinical diagnosis of bronchiolitis Exclusion Criteria: Age greater than 18 months Disease too mild to warrant any treatment Emergent intubation on arrival at the ED Participation within another study within 30 days Refusal of informed parental consent
Sites / Locations
- Kern Medical Center
Outcomes
Primary Outcome Measures
Successful hospital discharge at three days
Secondary Outcome Measures
Improvement in severity of disease score
Improvement in respiratory status
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00114478
Brief Title
Trial of Epinephrine and Albuterol in Bronchiolitis
Official Title
Randomized Controlled Trial of Epinephrine and Albuterol in Bronchiolitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Kern Medical Center
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to see which of the two most common drugs used to treat bronchiolitis works better. A child's participation in this study is expected to last less than 4 hours. Approximately 600 patients will be recruited to participate in this study at Kern Medical Center (KMC).
Bronchiolitis is a very common lung infection in babies. There are many drugs used to treat this disease but nobody knows which one, if any, works the best. Two of the most commonly used drugs are albuterol and epinephrine. These are both drugs given during breathing treatments with oxygen and a mask. We are doing this study to see which of these drugs works better or if they are both equally good. The study works as follows: after the consent process the baby gets three treatments.
Nebulizer 1 (Treatment)
Treatment + 30 minutes (approximately) Nebulizer 2
Treatment + 60 minutes (approximately) Nebulizer 3
Treatment + 120 minutes (approximately)
The baby will be reevaluated and either discharged home or revert to standard therapy. If the baby is discharged directly from the emergency department (E.D.), we will call you in three days time to see how he/she is doing.
Detailed Description
Double blind RCT. Primary outcome measure is admission defined as actual admission or discharge with unscheduled return leading to admission within 72 hours. Secondary endpoints include change in severity of illness and response of respiratory parameters to treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Bronchiolitis, disposition, pediatric, epinephrine, albuterol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Intervention Type
Drug
Intervention Name(s)
albuterol (salbutamol)
Primary Outcome Measure Information:
Title
Successful hospital discharge at three days
Secondary Outcome Measure Information:
Title
Improvement in severity of disease score
Title
Improvement in respiratory status
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A clinical diagnosis of bronchiolitis
Exclusion Criteria:
Age greater than 18 months
Disease too mild to warrant any treatment
Emergent intubation on arrival at the ED
Participation within another study within 30 days
Refusal of informed parental consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Walsh, Paul Walsh, MD MSc(peds)
Organizational Affiliation
Kern Medical Center, David Geffen School of Medicine, UCLA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Walsh
Organizational Affiliation
Research Director, Emergency Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kern Medical Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93312
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15359199
Citation
Walsh P, Rothenberg SJ, O'Doherty S, Hoey H, Healy R. A validated clinical model to predict the need for admission and length of stay in children with acute bronchiolitis. Eur J Emerg Med. 2004 Oct;11(5):265-72. doi: 10.1097/00063110-200410000-00005.
Results Reference
background
PubMed Identifier
18370982
Citation
Walsh P, Caldwell J, McQuillan KK, Friese S, Robbins D, Rothenberg SJ. Comparison of nebulized epinephrine to albuterol in bronchiolitis. Acad Emerg Med. 2008 Apr;15(4):305-13. doi: 10.1111/j.1553-2712.2008.00064.x.
Results Reference
derived
Links:
URL
http://groups.yahoo.com/group/kmcemrap
Description
Research assistant site for this study. Restricted access.
Learn more about this trial
Trial of Epinephrine and Albuterol in Bronchiolitis
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