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ISRCTN
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ISRCTN66632312
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ClinicalTrials.gov identifier
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Public title
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A comparison of nebulized 3% hypertonic saline and epinephrine versus nebulized normal saline and epinephrine in the treatment of acute bronchiolitis
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Scientific title
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Acronym
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BREATH
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Serial number at source
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N/A
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Study hypothesis
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Bronchiolitis which is the most common lower respiratory tract infection under the age of one. Symptoms can range from mild to severe and include fever, rhinorrhea, cough, and dyspnea.
Compared to nebulized racemic epinephrine in normal saline, patients with acute bronchiolitis in the emergency department treated with nebulized racemic epinephrine in 3% hypertonic saline will have a statistically significant improvement in their Respiratory Assessment Change Score (RACS).
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Bronchiolitis
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Participants - inclusion criteria
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Infants 6 weeks to 12 months of age with clinical symptoms of a viral respiratory infection (coryza or temperature ≥ 38.0°C), first episode of wheezing, oxygen saturation ≥ 85% but ≤ 96%, and initial Respiratory Distress Assessment Instrument (RDAI) score ≥ 4.
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Participants - exclusion criteria
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Pre-existing cardiac or pulmonary disease, previous diagnosis of asthma by a physician, any previous use of bronchodilators, severe disease requiring resuscitation room care, inability to administer medication by nebulizer, inability to obtain informed consent secondary to a language barrier, or no phone access for follow-up.
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Anticipated start date
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14/02/2004
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Anticipated end date
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14/03/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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46
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Interventions
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Patients who entered the study were randomized to receive either nebulized epinephrine in hypertonic saline or nebulized epinephrine in normal saline. Each patient had his or her oxygen saturation level, heart rate, respiratory rate and Respiratory Distress Assessment Instrument (RDAI) score measured at baseline and then again at 30, 60, 90 and 120 minutes. The nurses, physicians and study team personnel remained blinded throughout the study. There were no invasive procedures involved.
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Primary outcome measure(s)
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The Respiratory Assessment Change Score (RACS) was the primary outcome variable of the study. This score is a clinical scoring system based on the Respiratory Distress Assessment Index (RDAI) and the respiratory rate.
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Secondary outcome measure(s)
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Oxygen saturation and rate of admission to hospital.
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Sources of funding
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Department of Pediatrics, University of Alberta, Edmonton, Alberta (Canada)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19884591
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Contact name
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Dr
Simran
Grewal
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Address
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2nd Floor, Rm 7217B
Aberhart Centre 1
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City/town
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Edmonton, AB
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Zip/Postcode
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T6G 2J3
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Country
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Canada
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Sponsor
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University of Alberta, Department of Pediatrics (Canada)
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Address
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8213 Aberhart Centre 1
11402 University Avenue
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City/town
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Edmonton, AB
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Zip/Postcode
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T6G 2J3
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Country
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Canada
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Date applied
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01/09/2005
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Last edited
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16/11/2009
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Date ISRCTN assigned
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13/09/2005
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