<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/NCT03252119</url>
  </required_header>
  <id_info>
    <org_study_id>M170234</org_study_id>
    <nct_id>NCT03252119</nct_id>
  </id_info>
  <brief_title>High Flow Oxygen Therapy vs Standard Care in Infants With Viral Bronchiolitis</brief_title>
  <official_title>High Flow Oxygen Therapy vs Standard Care in Infants With Viral Bronchiolitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chris Hani Baragwanath Academic Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chris Hani Baragwanath Academic Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized control trial of 130 infants admitted to the paediatric high care admission ward&#xD;
      will be enrolled, and randomized to either &quot;high flow humidified oxygen&quot; or &quot;standard&#xD;
      therapy&quot;.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized control trial of 130 infants admitted to the paediatric high care admission ward&#xD;
      will be enrolled. Infants between 1 month and 2 years of age who fulfill criteria for&#xD;
      enrollment shall be considered eligible. Informed consent from parents or legal guardians&#xD;
      shall be obtained. Infants shall be randomized to either &quot;standard therapy&quot; or &quot;high flow&#xD;
      humidified oxygen&quot;. Measurements of heart rate, respiratory rate, work of breathing (Tal&#xD;
      score and WCAS), oxygen saturation and oxygen requirements shall be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    High flow oxygen therapy became available as standard care&#xD;
  </why_stopped>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of high flow humidified oxygen therapy on work of breathing</measure>
    <time_frame>during first 5 days post enrollment</time_frame>
    <description>Respiratory rate (n/min)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of high flow humidified oxygen therapy on work of breathing</measure>
    <time_frame>first 5 days post enrollment</time_frame>
    <description>Use of accessory muscles of respiration (present /not)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of high flow humidified oxygen therapy on blood oxygen saturations</measure>
    <time_frame>first 5 days post enrollment</time_frame>
    <description>Saturation of oxygen (% saturation) as measured by pulse oximeter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of high flow humidified oxygen therapy on heart rate</measure>
    <time_frame>first 5 days post enrollment</time_frame>
    <description>Pulse (n/min) measured by ECG monitor</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients requiring intubation and ventilation</measure>
    <time_frame>from time of enrollment to end of hospital stay (up to 6 months)</time_frame>
    <description>number of patients (N) getting intubated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>from time of enrollment to end of hospital stay (up to 6 months)</time_frame>
    <description>days (N) spent in hospital</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Bronchiolitis, Viral</condition>
  <arm_group>
    <arm_group_label>standard therapy group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>standard treatment of viral bronchiolitis with low flow oxygen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high flow humidified oxygen group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>treatment of viral bronchiolitis with high flow humidified oxygen therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High flow humidified oxygen therapy</intervention_name>
    <description>application of high flow humidified oxygen therapy at 2l/kg/min</description>
    <arm_group_label>high flow humidified oxygen group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of viral bronchiolitis&#xD;
&#xD;
          -  Not requiring intubation and ventilation&#xD;
&#xD;
          -  Admitted to high care unit&#xD;
&#xD;
          -  With moderate/severe respiratory distress (Tal score &gt;6)&#xD;
&#xD;
          -  Saturations &lt;92% in room air&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  congenital cardiac disease&#xD;
&#xD;
          -  presence of multiorgan failure/multisystemic disease&#xD;
&#xD;
          -  previously ventilated&#xD;
&#xD;
          -  craniofacial abnormalities&#xD;
&#xD;
          -  nasal pathology&#xD;
&#xD;
          -  decreased level of consciousness&#xD;
&#xD;
          -  Ex-prem &lt;34 weeks&#xD;
&#xD;
          -  Possible impending respiratory failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan M Murphy, FCPaed (SA)</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of the Witwatersrand, Johannesburg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chris Hani Baragwanath Academic Hospital</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>May 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>July 23, 2019</last_update_submitted>
  <last_update_submitted_qc>July 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chris Hani Baragwanath Academic Hospital</investigator_affiliation>
    <investigator_full_name>Susan Murphy</investigator_full_name>
    <investigator_title>Specialist Intensivist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</mesh_term>
    <mesh_term>Bronchiolitis, Viral</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share data wit other researchers</ipd_description>
  </patient_data>
  <!-- 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/NCT03252119
org study id: M170234
nct id: NCT03252119
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
A randomized control trial of 130 infants admitted to the paediatric high care admission ward
      will be enrolled, and randomized to either "high flow humidified oxygen" or "standard
      therapy".
A randomized control trial of 130 infants admitted to the paediatric high care admission ward
      will be enrolled. Infants between 1 month and 2 years of age who fulfill criteria for
      enrollment shall be considered eligible. Informed consent from parents or legal guardians
      shall be obtained. Infants shall be randomized to either "standard therapy" or "high flow
      humidified oxygen". Measurements of heart rate, respiratory rate, work of breathing (Tal
      score and WCAS), oxygen saturation and oxygen requirements shall be recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effect of high flow humidified oxygen therapy on work of breathing
time frame: during first 5 days post enrollment
description: Respiratory rate (n/min)
measure: Effect of high flow humidified oxygen therapy on work of breathing
time frame: first 5 days post enrollment
description: Use of accessory muscles of respiration (present /not)
measure: Effect of high flow humidified oxygen therapy on blood oxygen saturations
time frame: first 5 days post enrollment
description: Saturation of oxygen (% saturation) as measured by pulse oximeter
measure: Effect of high flow humidified oxygen therapy on heart rate
time frame: first 5 days post enrollment
description: Pulse (n/min) measured by ECG monitor
measure: Proportion of patients requiring intubation and ventilation
time frame: from time of enrollment to end of hospital stay (up to 6 months)
description: number of patients (N) getting intubated
measure: Length of hospital stay
time frame: from time of enrollment to end of hospital stay (up to 6 months)
description: days (N) spent in hospital
arm group label: standard therapy group
arm group type: No Intervention
description: standard treatment of viral bronchiolitis with low flow oxygen.
arm group label: high flow humidified oxygen group
arm group type: Experimental
description: treatment of viral bronchiolitis with high flow humidified oxygen therapy.
intervention type: Device
intervention name: High flow humidified oxygen therapy
description: application of high flow humidified oxygen therapy at 2l/kg/min
arm group label: high flow humidified oxygen group
criteria: 
gender: All
minimum age: 1 Month
maximum age: 2 Years
healthy volunteers: No
last name: Susan M Murphy, FCPaed (SA)
role: Principal Investigator
affiliation: University of the Witwatersrand, Johannesburg
facility: 
country: South Africa
responsible party type: Principal Investigator
investigator affiliation: Chris Hani Baragwanath Academic Hospital
investigator full name: Susan Murphy
investigator title: Specialist Intensivist
mesh term: Bronchiolitis
mesh term: Bronchiolitis, Viral
sharing ipd: No
ipd description: No plan to share data wit other researchers