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Trial of Epinephrine and Albuterol in Bronchiolitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Kern Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Kern Medical Center
ClinicalTrials.gov Identifier:
NCT00114478
First received: June 15, 2005
Last updated: January 23, 2008
Last verified: January 2008

June 15, 2005
January 23, 2008
November 2003
Not Provided
Successful hospital discharge at three days
Same as current
Complete list of historical versions of study NCT00114478 on ClinicalTrials.gov Archive Site
  • Improvement in severity of disease score
  • Improvement in respiratory status
Same as current
Not Provided
Not Provided
 
Trial of Epinephrine and Albuterol in Bronchiolitis
Randomized Controlled Trial of Epinephrine and Albuterol in Bronchiolitis

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Bronchiolitis
  • Drug: Epinephrine
  • Drug: albuterol (salbutamol)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
May 2006
Not Provided

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
Both
up to 18 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00114478
KMC03034
Not Provided
Not Provided
Kern Medical Center
Not Provided
Principal Investigator: Paul Walsh, Paul Walsh, MD MSc(peds) Kern Medical Center, David Geffen School of Medicine, UCLA
Principal Investigator: Paul Walsh Research Director, Emergency Medicine
Kern Medical Center
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP