Trial of Epinephrine and Albuterol in Bronchiolitis

Bronchiolitis Clinical Trial

Official title:

Randomized Controlled Trial of Epinephrine and Albuterol in Bronchiolitis

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00114478
• Other study ID #: KMC03034
• Status: Unknown status
• Phase: N/A
• First received: June 15, 2005
• Last updated: January 23, 2008
• Start date: November 2003
• Est. completion date: May 2006

Study information

• Verified date: January 2008
• Source: Kern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 600
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Drug:
• Epinephrine

• albuterol (salbutamol)

Locations

Country	Name	City	State
United States	Kern Medical Center	Bakersfield	California

Sponsors (1)

Lead Sponsor	Collaborator
Kern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful hospital discharge at three days
Secondary	Improvement in severity of disease score
Secondary	Improvement in respiratory status

External Links

•   Research assistant site for this study. Restricted access.