Bronchiolitis |
Chronic Bronchitis |
Clinical Trial: Trial of Epinephrine and Albuterol in Bronchiolitis
This study is currently recruiting patients.
|
Purpose
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.
| Condition | Intervention |
|---|---|
| Bronchiolitis | Drug: Epinephrine Drug: albuterol (salbutamol) |
MedlinePlus related topics: Bronchitis; Respiratory Syncytial Virus Infections
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Randomized Controlled Trial of Epinephrine and Albuterol in Bronchiolitis
Secondary Outcomes: Improvement in severity of disease score; Improvement in respiratory status
Expected Total Enrollment: 600
Study start: November 2003; Expected completion: September 2006
Data entry closure: April 2006
Eligibility
Inclusion Criteria:
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
Location and Contact Information
California
Kern Medical Center, Bakersfield, California, 93312, United States; Recruiting
Paul Walsh, MD MSc(peds), Principal Investigator
Paul Walsh, Paul Walsh, MD MSc(peds), Principal Investigator
More Information
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.
Record last reviewed: June 2005
Last Updated: June 30, 2005
Record first received: June 15, 2005
ClinicalTrials.gov Identifier: NCT00114478
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-05

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