Inhaled Hypertonic Saline for Bronchiolitis

Queen's University

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Bronchiolitis

Interventions

inhaled 7% hypertonic salineOTHER

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

inhaled nebulized normal salineOTHER

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

Eligibility

Sex: ALLMin age: 4 WeeksMax age: 24 Months

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age under 2 years 2. History of viral upper respiratory infection within previous 7 days 3. Wheezing or crackles detected on chest auscultation 4. 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.

Locations (3)

Victoria General Hospital

Victoria, British Columbia, Canada

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Southeastern Ontario Health Sciences Centre

Kingston, Ontario, Canada

Outcomes

Primary Outcomes

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

Time frame: 120 minutes after baseline pre-treatment

Secondary Outcomes

rates of admission to hospital

Time frame: 7 days

length-of-stay of admitted patients

Time frame: 28 days

rates of unscheduled return for respiratory illness to the ED

Time frame: 14 days

Data from ClinicalTrials.gov

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