Clinical trial NCT02253576: Inhaled Hypertonic Saline for Bronchiolitis
Official title: 7% Hypertonic Saline to Treat Bronchiolitis in the Emergency Department
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bronchiolitis
Keywords: infant
bronchiolitis
hypertonic saline
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2014-10-01
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change in respiratory distress, as measured by the Respiratory Assessment Change Score (RACS),
timeFrame: 120 minutes after baseline pre-treatment
Secondary outcomes:
measure: rates of admission to hospital
timeFrame: 7 days
measure: length-of-stay of admitted patients
timeFrame: 28 days
measure: rates of unscheduled return for respiratory illness to the ED
timeFrame: 14 days
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: Victoria General Hospital
state: British Columbia
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Kingston
country: Canada
facility: Southeastern Ontario Health Sciences Centre
state: Ontario
Study officials:
affiliation: Queen's University
name: Michael Flavin, MD
role: PRINCIPAL_INVESTIGATOR
References: