Overview

This trial is active, not recruiting.

Condition bronchiolitis
Treatments epinephrine, albuterol (salbutamol)
Sponsor Kern Medical Center
Start date November 2003
End date May 2006
Trial size 600 participants
Trial identifier NCT00114478, KMC03034

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
Successful hospital discharge at three days
time frame:

Secondary Outcomes

Measure
Improvement in severity of disease score
time frame:
Improvement in respiratory status
time frame:

Eligibility Criteria

Male or female participants up to 18 months old.

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

Additional Information

Official title Randomized Controlled Trial of Epinephrine and Albuterol in Bronchiolitis
Principal investigator Paul Walsh, Paul Walsh, MD MSc(peds)
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2008.
Information provided to ClinicalTrials.gov by Kern Medical Center.