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Inhaled Hypertonic Saline for Bronchiolitis (7HSinED)

Primary Purpose

Bronchiolitis

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
inhaled 7% hypertonic saline
inhaled nebulized normal saline
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring infant, bronchiolitis, hypertonic saline

Eligibility Criteria

4 Weeks - 24 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Victoria General Hospital
  • Royal Victoria Regional Health Centre
  • Southeastern Ontario Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

inhaled 7% hypertonic saline

inhaled nebulized normal saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

rates of admission to hospital
length-of-stay of admitted patients
rates of unscheduled return for respiratory illness to the ED

Full Information

First Posted
September 29, 2014
Last Updated
November 12, 2015
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT02253576
Brief Title
Inhaled Hypertonic Saline for Bronchiolitis
Acronym
7HSinED
Official Title
7% Hypertonic Saline to Treat Bronchiolitis in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Study not funded - never initiated
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
infant, bronchiolitis, hypertonic saline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
inhaled 7% hypertonic saline
Arm Type
Experimental
Arm Description
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
Arm Title
inhaled nebulized normal saline
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
inhaled 7% hypertonic saline
Intervention Description
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
Intervention Name(s)
inhaled nebulized normal saline
Intervention Description
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
Primary Outcome Measure Information:
Title
The change in respiratory distress, as measured by the Respiratory Assessment Change Score (RACS),
Description
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
Time Frame
120 minutes after baseline pre-treatment
Secondary Outcome Measure Information:
Title
rates of admission to hospital
Time Frame
7 days
Title
length-of-stay of admitted patients
Time Frame
28 days
Title
rates of unscheduled return for respiratory illness to the ED
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age under 2 years History of viral upper respiratory infection within previous 7 days Wheezing or crackles detected on chest auscultation 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Flavin, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Victoria General Hospital
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8Z 6R5
Country
Canada
Facility Name
Royal Victoria Regional Health Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4N 6S7
Country
Canada
Facility Name
Southeastern Ontario Health Sciences Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L2V6
Country
Canada

12. IPD Sharing Statement

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Inhaled Hypertonic Saline for Bronchiolitis

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