Trial of Epinephrine and Albuterol in Bronchiolitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2006-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Epinephrine

Intervention Type DRUG

albuterol (salbutamol)

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No