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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-12-31

Study Completion Date

2001-05-31

Brief Summary

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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

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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.

Conditions

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Rsv Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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nebulized epinephrine and nebulized albuterol

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

0 Years

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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LEA BENTUR, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam medical centre, pediatric pulmonary unit, HAIFA

Locations

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Pediatric Ward, Rambam Medical Centre

Haifa, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED

PMID: 17543129 (View on PubMed)

Other Identifiers

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epinephrine_albuterol_rsv.ctil

Identifier Type: -

Identifier Source: org_study_id