Trial of Epinephrine and Albuterol in Bronchiolitis

Condition(s) targeted: Bronchiolitis

Intervention: Epinephrine (Drug); albuterol (salbutamol) (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Kern Medical Center

Official(s) and/or principal investigator(s):
Paul Walsh, Paul Walsh, MD MSc(peds), Principal Investigator, Affiliation: Kern Medical Center, David Geffen School of Medicine, UCLA
Paul Walsh, Principal Investigator, Affiliation: Research Director, Emergency Medicine

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.

Official title: Randomized Controlled Trial of Epinephrine and Albuterol in Bronchiolitis

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Successful hospital discharge at three days

Secondary outcome:

Improvement in severity of disease score

Improvement in respiratory status

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.

Minimum age: N/A. Maximum age: 18 Months. Gender(s): Both.

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

Kern Medical Center, Bakersfield, California 93312, United States

Research assistant site for this study. Restricted access.

Website of the Emergency Department conducting this study

Related publications:

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.

Starting date: November 2003
Ending date: May 2006
Last updated: January 23, 2008