<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02253576</url>
  </required_header>
  <id_info>
    <org_study_id>Kuz-7HS</org_study_id>
    <nct_id>NCT02253576</nct_id>
  </id_info>
  <brief_title>Inhaled Hypertonic Saline for Bronchiolitis</brief_title>
  <acronym>7HSinED</acronym>
  <official_title>7% Hypertonic Saline to Treat Bronchiolitis in the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen's University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Queen's University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study Design: This randomized, double blind, controlled, multi-centre study will occur in the&#xD;
      Emergency Department, hospital-based Urgent Care Centre or paediatric outpatient clinics&#xD;
      (collectively &quot;ED&quot;) of 3 General Hospitals in Ontario and 1 in British Columbia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children under age 2 years presenting for unscheduled care to the ED with a diagnosis of&#xD;
      moderately severe bronchiolitis (as defined by inclusion/exclusion criteria below) will be&#xD;
      approached for entry into the study. Recruitment will only occur when Research Assistants are&#xD;
      on duty, is projected to include regular working hours Monday-Friday as a minimum and will&#xD;
      continue until the calculated sample size has been obtained (anticipated 12 months). Initial&#xD;
      routine assessment by the ED staff will identify potential subjects and Research Assistants&#xD;
      will be notified to apply the inclusion/exclusion criteria and obtain informed consent if&#xD;
      appropriate. Recruited subjects will be randomized to receive treatment in a double blind&#xD;
      fashion with inhalation of nebulized study solution containing either 7% hypertonic saline&#xD;
      (HS, study group) or 0.9% saline (NS, control group). Each dose of study solution will also&#xD;
      contain a standard dose of bronchodilator (salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5%&#xD;
      salbutamol nebulizer solution) added by the ED staff. Each participant will remain on the&#xD;
      same allocation throughout the protocol and receive 3 consecutive 4ml doses of the assigned&#xD;
      study solution with salbutamol over a 1-hour period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study not funded - never initiated&#xD;
  </why_stopped>
  <start_date>June 2014</start_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change in respiratory distress, as measured by the Respiratory Assessment Change Score (RACS),</measure>
    <time_frame>120 minutes after baseline pre-treatment</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>rates of admission to hospital</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length-of-stay of admitted patients</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rates of unscheduled return for respiratory illness to the ED</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Bronchiolitis</condition>
  <arm_group>
    <arm_group_label>inhaled 7% hypertonic saline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>inhaled nebulized normal saline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>inhaled 7% hypertonic saline</intervention_name>
    <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</description>
    <arm_group_label>inhaled 7% hypertonic saline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>inhaled nebulized normal saline</intervention_name>
    <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</description>
    <arm_group_label>inhaled nebulized normal saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age under 2 years&#xD;
&#xD;
          2. History of viral upper respiratory infection within previous 7 days&#xD;
&#xD;
          3. Wheezing or crackles detected on chest auscultation&#xD;
&#xD;
          4. Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater or oxygen&#xD;
             saturation (SaO2) of 94% or less in room air.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        History of immunodeficiency, chronic cardiopulmonary disease (other than past history of&#xD;
        wheezing), Down syndrome, gestational age under 34 weeks.&#xD;
&#xD;
        Severe illness at presentation as defined by any of the following Respiratory rate greater&#xD;
        than 80/min SaO2 less than 88% in room air Need for assisted ventilation Use of nebulized&#xD;
        HS within previous 12 hours Previous enrollment in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Weeks</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Flavin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen's University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Victoria General Hospital</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8Z 6R5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Victoria Regional Health Centre</name>
      <address>
        <city>Barrie</city>
        <state>Ontario</state>
        <zip>L4N 6S7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Ontario Health Sciences Centre</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L2V6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>November 12, 2015</last_update_submitted>
  <last_update_submitted_qc>November 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Queen's University</investigator_affiliation>
    <investigator_full_name>Dr. Michael Flavin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>infant</keyword>
  <keyword>bronchiolitis</keyword>
  <keyword>hypertonic saline</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02253576
org study id: Kuz-7HS
nct id: NCT02253576
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The change in respiratory distress, as measured by the Respiratory Assessment Change Score (RACS),
time frame: 120 minutes after baseline pre-treatment
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
measure: rates of admission to hospital
time frame: 7 days
measure: length-of-stay of admitted patients
time frame: 28 days
measure: rates of unscheduled return for respiratory illness to the ED
time frame: 14 days
arm group label: inhaled 7% hypertonic saline
arm group type: Experimental
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 group label: inhaled nebulized normal saline
arm group type: Active Comparator
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: inhaled 7% hypertonic saline
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
arm group label: inhaled 7% hypertonic saline
intervention type: Other
intervention name: inhaled nebulized normal saline
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
arm group label: inhaled nebulized normal saline
criteria: 
gender: All
minimum age: 4 Weeks
maximum age: 24 Months
healthy volunteers: No
last name: Michael Flavin, MD
role: Principal Investigator
affiliation: Queen's University
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Queen's University
investigator full name: Dr. Michael Flavin
investigator title: Principal Investigator
mesh term: Bronchiolitis