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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
Kern Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Bronchiolitis, disposition, pediatric, epinephrine, albuterol

Eligibility Criteria

undefined - 18 Months (Child)All SexesDoes not accept healthy volunteers

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

First Posted
June 15, 2005
Last Updated
January 23, 2008
Sponsor
Kern Medical Center
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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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