Trial of Epinephrine and Albuterol in Bronchiolitis

Study Overview
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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.

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.

Official Title
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Randomized Controlled Trial of Epinephrine and Albuterol in Bronchiolitis

Conditions
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Bronchiolitis

Intervention / Treatment
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* Drug: Epinephrine
* Drug: albuterol (salbutamol)


Participation Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Epinephrine|nan|
|Drug: albuterol (salbutamol)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful hospital discharge at three days |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in severity of disease score |  |  | 
| Improvement in respiratory status |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchiolitis, disposition, pediatric, epinephrine, albuterol