Inhaled Hypertonic Saline for Bronchiolitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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7% Hypertonic Saline to Treat Bronchiolitis in the Emergency Department

Conditions
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Bronchiolitis

Intervention / Treatment
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* Other: inhaled 7% hypertonic saline
* Other: inhaled nebulized normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 4 Weeks
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inhaled 7% hypertonic saline<br>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 | Other: inhaled 7% hypertonic saline<br>* Three consecutive doses of 4 ml of 7% hypertonic saline added to salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution over 1 hour<br>|
| Active Comparator: inhaled nebulized normal saline<br>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 | Other: inhaled nebulized normal saline<br>* Three consecutive doses of 4 ml of 0.9% NaCl added to salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution over 1 hour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in respiratory distress, as measured by the Respiratory Assessment Change Score (RACS), | 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 | 120 minutes after baseline pre-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rates of admission to hospital |  | 7 days | 
| length-of-stay of admitted patients |  | 28 days | 
| rates of unscheduled return for respiratory illness to the ED |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant, bronchiolitis, hypertonic saline