Inhaled Hypertonic Saline for Bronchiolitis

NCT ID: NCT02253576

Last Updated: 2015-11-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30

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.

Conditions

Bronchiolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

inhaled 7% hypertonic saline

Three consecutive 4ml doses of 7% NaCl solution with salbutamol(0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) nebulized over a 1-hour period

Group Type: EXPERIMENTAL

inhaled 7% hypertonic saline

Intervention Type: OTHER

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 4ml doses of 0.9 NaCl solution added to salbutamol(0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) nebulized over a 1-hour period

Group Type: ACTIVE_COMPARATOR

inhaled nebulized normal saline

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 4 Weeks
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Michael Flavin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Flavin, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Victoria General Hospital

Victoria, British Columbia, Canada

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Southeastern Ontario Health Sciences Centre

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

Kuz-7HS

Identifier Type: -

Identifier Source: org_study_id