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

Primary Purpose

Rsv Bronchiolitis

Status
Terminated
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
nebulized epinephrine and nebulized albuterol
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rsv Bronchiolitis

Eligibility Criteria

0 Years - 1 Year (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pediatric Ward, Rambam Medical Centre

Outcomes

Primary Outcome Measures

respiratory clinical score
computerized quantification of wheezing and crackles

Secondary Outcome Measures

Full Information

First Posted
August 6, 2006
Last Updated
August 6, 2006
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT00361452
Brief Title
Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study
Official Title
Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2000
Overall Recruitment Status
Terminated
Study Start Date
December 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Rambam Health Care Campus

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rsv Bronchiolitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
nebulized epinephrine and nebulized albuterol
Primary Outcome Measure Information:
Title
respiratory clinical score
Title
computerized quantification of wheezing and crackles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LEA BENTUR, MD
Organizational Affiliation
Rambam medical centre, pediatric pulmonary unit, HAIFA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Ward, Rambam Medical Centre
City
Haifa
ZIP/Postal Code
31096
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
17543129
Citation
Beck R, Elias N, Shoval S, Tov N, Talmon G, Godfrey S, Bentur L. Computerized acoustic assessment of treatment efficacy of nebulized epinephrine and albuterol in RSV bronchiolitis. BMC Pediatr. 2007 Jun 2;7:22. doi: 10.1186/1471-2431-7-22.
Results Reference
derived

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

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