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

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ClinicalTrials.gov Identifier: NCT00361452
Recruitment Status : Terminated
First Posted : August 8, 2006
Last Update Posted : August 8, 2006
Information provided by:
Rambam Health Care Campus

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.

Condition or disease Intervention/treatment Phase
Rsv Bronchiolitis Drug: nebulized epinephrine and nebulized albuterol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study
Study Start Date : December 2000
Study Completion Date : May 2001

Primary Outcome Measures :
  1. respiratory clinical score
  2. computerized quantification of wheezing and crackles

Information from the National Library of Medicine

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Ages Eligible for Study:   0 Years to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00361452

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Pediatric Ward, Rambam Medical Centre
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
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Principal Investigator: LEA BENTUR, MD Rambam medical centre, pediatric pulmonary unit, HAIFA
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00361452    
Other Study ID Numbers: epinephrine_albuterol_rsv.ctil
First Posted: August 8, 2006    Key Record Dates
Last Update Posted: August 8, 2006
Last Verified: November 2000
Additional relevant MeSH terms:
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Respiratory Tract Infections
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists