Trial of Epinephrine and Albuterol in Bronchiolitis

Sponsor

Kern Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00114478

Collaborator

(none)

600

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis	Drug: Epinephrine Drug: albuterol (salbutamol)	N/A

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Randomized Controlled Trial of Epinephrine and Albuterol in Bronchiolitis

Study Start Date :

Nov 1, 2003

Study Completion Date :

May 1, 2006

Outcome Measures

Primary Outcome Measures

Successful hospital discharge at three days []

Secondary Outcome Measures

Improvement in severity of disease score []
Improvement in respiratory status []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Months

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kern Medical Center	Bakersfield	California	United States	93312

Sponsors and Collaborators

Kern Medical Center

Investigators

Principal Investigator: Paul Walsh, Paul Walsh, MD MSc(peds), Kern Medical Center, David Geffen School of Medicine, UCLA
Principal Investigator: Paul Walsh, Research Director, Emergency Medicine