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Trial of Epinephrine and Albuterol in Bronchiolitis

Randomized Controlled Trial of Epinephrine and Albuterol in Bronchiolitis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00114478
Enrollment
600
Registered
2005-06-16
Start date
2003-11-30
Completion date
2006-05-31
Last updated
2008-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis

Keywords

Bronchiolitis, disposition, pediatric, epinephrine, albuterol

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.

Interventions

DRUGEpinephrine

Sponsors

Kern Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Successful hospital discharge at three days

Secondary

MeasureTime frame
Improvement in severity of disease score
Improvement in respiratory status

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026