Inhaled Hypertonic Saline for Bronchiolitis

Bronchiolitis Clinical Trial

— 7HSinED  

Official title:

7% Hypertonic Saline to Treat Bronchiolitis in the Emergency Department

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02253576
• Other study ID #: Kuz-7HS
• Status: Withdrawn
• Phase: N/A
• First received: September 29, 2014
• Last updated: November 12, 2015
• Start date: June 2014

Study information

• Verified date: November 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

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
• 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

Locations

Country	Name	City	State
Canada	Royal Victoria Regional Health Centre	Barrie	Ontario
Canada	Southeastern Ontario Health Sciences Centre	Kingston	Ontario
Canada	Victoria General Hospital	Victoria	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	rates of admission to hospital		7 days	No
Secondary	length-of-stay of admitted patients		28 days	No
Secondary	rates of unscheduled return for respiratory illness to the ED		14 days	No