Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study

Rsv Bronchiolitis Clinical Trial

Official title:

Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00361452
• Other study ID #: epinephrine_albuterol_rsv.ctil
• Status: Terminated
• Phase: Phase 4
• First received: August 6, 2006
• Last updated: August 6, 2006
• Start date: December 2000
• Est. completion date: May 2001

Study information

• Verified date: November 2000
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Bronchiolitis is a common disease of infancy and a main reason for infants' hospital admissions in the first 2 years of life. The main cause of bronchiolitis is RSV (respiratory syncytial virus). Though, Treatment is mainly supportive, the treatment benefit of nebulized epinephrine or albuterol has been largely debated for the past years. Most of the clinical studies used clinical parameters to detect and compare the effectiveness of such medical interventions. In this study we will use non invasive computerized method of wheeze and crackles quantification to compare the effectiveness of nebulized epinephrine vs albuterol in RSV Bronchiolitis.

Description:

Inpatient Infants younger than 2 years of age with first episode of RSV bronchiolitis will be randomly assigned to treatment with nebulized epinephrine (1 mg diluted with 3 ml of 0.9% saline) or nebulized albuterol (2.5 mg diluted with 3.5 ml of 0.9% saline). Both solutions will be provided in identical containers.

Clinical assessment and clinical score will be done before treatment, 10 and 30 minutes after treatment. The following parameters were recorded at each time point, wheezing, respiratory distress, O2 saturation, respiratory rate and heart rate. Computerized lung sounds as well, will be recorded before treatment, 10 and 30 minutes after treatment via 4 contact sensors attached to the chest.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: May 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

Inclusion Criteria:

• Under one year of age

• first episode of wheezing and dyspnea

• RSV antigen detected by ELISA

• parents signed informed consent.

Exclusion Criteria:

• infants with chronic lung disease

• cardiac disease

• other chronic conditions.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis
• Rsv Bronchiolitis

Intervention

Drug:
• nebulized epinephrine and nebulized albuterol

Locations

Country	Name	City	State
Israel	Pediatric Ward, Rambam Medical Centre	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	respiratory clinical score
Primary	computerized quantification of wheezing and crackles