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Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study
This study has been terminated.
Study NCT00361452   Information provided by Rambam Health Care Campus
First Received: August 6, 2006   No Changes Posted

August 6, 2006
August 6, 2006
December 2000
 
  • respiratory clinical score
  • computerized quantification of wheezing and crackles
Same as current
No Changes Posted
 
 
 
Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study
Acoustic Assessment of Nebulized Epinephrine Versus Albuterol for RSV Bronchiolitis- a Double Blind Study

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.

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.

Phase IV
Interventional
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Rsv Bronchiolitis
Drug: nebulized epinephrine and nebulized albuterol
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
30
May 2001
 

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.
Both
up to 1 Year
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00361452
 
epinephrine_albuterol_rsv.ctil
Rambam Health Care Campus
 
Principal Investigator: LEA BENTUR, MD Rambam medical centre, pediatric pulmonary unit, HAIFA
Rambam Health Care Campus
November 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP