Trial of Epinephrine and Albuterol in Bronchiolitis

Not Applicable

• Conditions: Bronchiolitis

• Registration Number: NCT00114478
• Lead Sponsor: Kern Medical Center

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.

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2005-06-15
• Study First Submitted QC: 2005-06-15
• Study First Posted: 2005-06-16
• Study Completion: 2006-05
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-23
• Last Update Posted: 2008-01-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Successful hospital discharge at three days

Secondary Outcome Measures

Name	Time	Method
Improvement in severity of disease score
Improvement in respiratory status

Trial Locations

Locations (1)

Kern Medical Center; 🇺🇸 Bakersfield, California, United States