Inhaled Hypertonic Saline for Bronchiolitis
- Conditions
- Bronchiolitis
- Interventions
- Other: inhaled nebulized normal salineOther: inhaled 7% hypertonic saline
- Registration Number
- NCT02253576
- Lead Sponsor
- Queen's University
- Brief Summary
Study Design: This randomized, double blind, controlled, multi-centre study will occur in the Emergency Department, hospital-based Urgent Care Centre or paediatric outpatient clinics (collectively "ED") of 3 General Hospitals in Ontario and 1 in British Columbia.
- Detailed Description
Children under age 2 years presenting for unscheduled care to the ED with a diagnosis of moderately severe bronchiolitis (as defined by inclusion/exclusion criteria below) will be approached for entry into the study. Recruitment will only occur when Research Assistants are on duty, is projected to include regular working hours Monday-Friday as a minimum and will continue until the calculated sample size has been obtained (anticipated 12 months). Initial routine assessment by the ED staff will identify potential subjects and Research Assistants will be notified to apply the inclusion/exclusion criteria and obtain informed consent if appropriate. Recruited subjects will be randomized to receive treatment in a double blind fashion with inhalation of nebulized study solution containing either 7% hypertonic saline (HS, study group) or 0.9% saline (NS, control group). Each dose of study solution will also contain a standard dose of bronchodilator (salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) added by the ED staff. Each participant will remain on the same allocation throughout the protocol and receive 3 consecutive 4ml doses of the assigned study solution with salbutamol over a 1-hour period.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Age under 2 years
- History of viral upper respiratory infection within previous 7 days
- Wheezing or crackles detected on chest auscultation
- Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater or oxygen saturation (SaO2) of 94% or less in room air.
History of immunodeficiency, chronic cardiopulmonary disease (other than past history of wheezing), Down syndrome, gestational age under 34 weeks.
Severe illness at presentation as defined by any of the following Respiratory rate greater than 80/min SaO2 less than 88% in room air Need for assisted ventilation Use of nebulized HS within previous 12 hours Previous enrollment in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description inhaled nebulized normal saline inhaled nebulized normal saline Three consecutive 4ml doses of 0.9 NaCl solution added to salbutamol(0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) nebulized over a 1-hour period inhaled 7% hypertonic saline inhaled 7% hypertonic saline Three consecutive 4ml doses of 7% NaCl solution with salbutamol(0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) nebulized over a 1-hour period
- Primary Outcome Measures
Name Time Method The change in respiratory distress, as measured by the Respiratory Assessment Change Score (RACS), 120 minutes after baseline pre-treatment The response to treatment is determined by using the Respiratory Distress Assessment Instrument(RDAI) score and respiratory rate to calculate the Respiratory Assessment Change Score (RACS) i.e. RDAI score before minus RDAI score after treatment
- Secondary Outcome Measures
Name Time Method rates of unscheduled return for respiratory illness to the ED 14 days rates of admission to hospital 7 days length-of-stay of admitted patients 28 days
Trial Locations
- Locations (3)
Southeastern Ontario Health Sciences Centre
🇨🇦Kingston, Ontario, Canada
Royal Victoria Regional Health Centre
🇨🇦Barrie, Ontario, Canada
Victoria General Hospital
🇨🇦Victoria, British Columbia, Canada