Clinical Trial: Inhaled Hypertonic Saline for Bronchiolitis

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Queen's University

Current Primary Outcome: The change in respiratory distress, as measured by the Respiratory Assessment Change Score (RACS), [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Queen's University

Dates:
Date Received: September 29, 2014
Date Started: June 2014
Date Completion:
Last Updated: November 12, 2015
Last Verified: November 2015