Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
BREATH
Study hypothesis
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).
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Bronchiolitis
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Nebulized racemic epinephrine in normal saline and nebulized racemic epinephrine in 3% hypertonic saline
Primary outcome measures
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.
Secondary outcome measures
Oxygen saturation and rate of admission to hospital.
Overall trial start date
14/02/2004
Overall trial end date
14/03/2005
Reason abandoned
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
46
Participant exclusion criteria
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.
Recruitment start date
14/02/2004
Recruitment end date
14/03/2005
Locations
Countries of recruitment
Canada
Trial participating centre
2nd Floor, Rm 7217B
Edmonton, AB
T6G 2J3
Canada
Funders
Funder type
University/education
Funder name
Department of Pediatrics, University of Alberta, Edmonton, Alberta (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19884591
Publication citations
-
Results
Grewal S, Ali S, McConnell DW, Vandermeer B, Klassen TP, A randomized trial of nebulized 3% hypertonic saline with epinephrine in the treatment of acute bronchiolitis in the emergency department., Arch Pediatr Adolesc Med, 2009, 163, 11, 1007-1012, doi: 10.1001/archpediatrics.2009.196.