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Inhaled Hypertonic Saline for Bronchiolitis (7HSinED)

This study has been withdrawn prior to enrollment.
(Study not funded - never initiated)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02253576
First Posted: October 1, 2014
Last Update Posted: November 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Michael Flavin, Queen's University
  Purpose
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.

Condition Intervention
Bronchiolitis Other: inhaled 7% hypertonic saline Other: inhaled nebulized normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 7% Hypertonic Saline to Treat Bronchiolitis in the Emergency Department

Further study details as provided by Dr. Michael Flavin, Queen's University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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
Active Comparator: 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
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02253576


Locations
Canada, British Columbia
Victoria General Hospital
Victoria, British Columbia, Canada, V8Z 6R5
Canada, Ontario
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada, L4N 6S7
Southeastern Ontario Health Sciences Centre
Kingston, Ontario, Canada, K7L2V6
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Michael Flavin, MD Queen's University
  More Information

Responsible Party: Dr. Michael Flavin, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT02253576     History of Changes
Other Study ID Numbers: Kuz-7HS
First Submitted: September 29, 2014
First Posted: October 1, 2014
Last Update Posted: November 13, 2015
Last Verified: November 2015

Keywords provided by Dr. Michael Flavin, Queen's University:
infant
bronchiolitis
hypertonic saline

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pharmaceutical Solutions
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action