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Trial of Epinephrine and Albuterol in Bronchiolitis - Article


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Bronchiolitis

Chronic Bronchitis


Clinical Trial: Trial of Epinephrine and Albuterol in Bronchiolitis

This study is currently recruiting patients.

Sponsored by: Kern Medical Center
Information provided by: Kern Medical Center

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

Further Study Details: 
Primary Outcomes: Successful hospital discharge at three days
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

Ages Eligible for Study:  up to  18 Months,  Genders Eligible for Study:  Both
Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00114478


California
      Kern Medical Center, Bakersfield,  California,  93312,  United States; Recruiting
Paul Walsh, MD MSc(peds)  661-326-2161    yousentwhohome@yahoo.com 
Paul Walsh, MD MSc(peds),  Principal Investigator

Study chairs or principal investigators

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.

Study ID Numbers:  KMC03034
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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July 25, 2008



Page Updated: May 11, 2006
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