NCT02253576

Inhaled Hypertonic Saline for Bronchiolitis

7% Hypertonic Saline to Treat Bronchiolitis in the Emergency Department

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Queen's University · Academic / Other
• Sex: All
• Age: 4 Weeks – 24 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Bronchiolitis

Interventions

Type	Name	Description
OTHER	inhaled 7% hypertonic saline	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
OTHER	inhaled nebulized normal saline	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

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-06-01
• First posted: 2014-10-01
• Last updated: 2015-11-13

Locations

3 sites across 1 country: Canada