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

Information source: Rambam Health Care Campus
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rsv Bronchiolitis

Intervention: nebulized epinephrine and nebulized albuterol (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Rambam Health Care Campus

Official(s) and/or principal investigator(s):
LEA BENTUR, MD, Principal Investigator, Affiliation: Rambam medical centre, pediatric pulmonary unit, HAIFA

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.

Clinical Details

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

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

Primary outcome:

respiratory clinical score

computerized quantification of wheezing and crackles

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.

Eligibility

Minimum age: N/A. Maximum age: 1 Year. Gender(s): Both.

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.

Locations and Contacts

Pediatric Ward, Rambam Medical Centre, Haifa 31096, Israel
Additional Information

Starting date: December 2000
Last updated: August 6, 2006

Page last updated: August 23, 2015

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