Clinical trial NCT00114478: Trial of Epinephrine and Albuterol in Bronchiolitis
Official title: Randomized Controlled Trial of Epinephrine and Albuterol in Bronchiolitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchiolitis
Keywords: Bronchiolitis
disposition
pediatric
epinephrine
albuterol
Lead sponsor: Kern Medical Center
Sponsor class: OTHER
First posted: 2005-06-16
Enrollment: 600
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Successful hospital discharge at three days
Secondary outcomes:
measure: Improvement in severity of disease score
measure: Improvement in respiratory status
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Kern Medical Center
state: California
Study officials:
affiliation: Kern Medical Center, David Geffen School of Medicine, UCLA
name: Paul Walsh, Paul Walsh, MD MSc(peds)
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Director, Emergency Medicine
name: Paul Walsh
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.