<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/NCT02208323</url>
  </required_header>
  <id_info>
    <org_study_id>1406M51386</org_study_id>
    <secondary_id>12985</secondary_id>
    <nct_id>NCT02208323</nct_id>
  </id_info>
  <brief_title>Advancement of Modified Bubble CPAP</brief_title>
  <official_title>Advancement of Modified Bubble CPAP for the Use in Children in Low Resource Settings: A Study of Safety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs to&#xD;
      fit older children, will create a safe form of respiratory support that may help to decrease&#xD;
      respiratory distress and thus mortality from pneumonia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs to&#xD;
      fit older children, will create a safe form of respiratory support that may help to decrease&#xD;
      respiratory distress and thus mortality from pneumonia. Children age 1 month (mo) to 5 years&#xD;
      (y) admitted to Gulu Regional Referral Hospital in Gulu, Uganda with respiratory distress&#xD;
      will be evaluated for use of the modified bCPAP device as treatment for their respiratory&#xD;
      distress (in addition to their routine care, i.e. antibiotics, nutrition support)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>determine if a modified bCPAP device with an adapted nasal cannula can be used safely in children outside of the neonatal period</measure>
    <time_frame>28 days</time_frame>
    <description>A composite of potential adverse events that could be attributable to bCPAP use. Adverse events such as nasal erosion, nosebleed, and aerophagia will be graded on a scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>show decreased mortality in patients treated with a modified bCPAP respiratory support device.</measure>
    <time_frame>28 days</time_frame>
    <description>Comparison of historic mortality data for children admitted with respiratory distress to mortality rate seen during the study. Respiratory distress scores using the TAL score (18) will be recorded prior to therapy and throughout the hospital course</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Hypoxia</condition>
  <condition>Respiratory Distress</condition>
  <arm_group>
    <arm_group_label>Bubble CPAP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bubble CPAP for 28 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bubble CPAP</intervention_name>
    <description>Respiratory assistance</description>
    <arm_group_label>Bubble CPAP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 1mo-5y Hypoxia and/or respiratory distress Hypoxia- Oxygen saturation &lt;92% despite&#xD;
             2LPM nasal cannula support Modified TAL's Respiratory Score &gt;3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pneumothorax&#xD;
&#xD;
          -  Congenital lung disease&#xD;
&#xD;
          -  Cyanotic heart disease&#xD;
&#xD;
          -  Nasal trauma/facial injury/congenital anomaly (cleft) that makes bubble CPAP nasal&#xD;
             interface unusable&#xD;
&#xD;
          -  Nasal tissue injury&#xD;
&#xD;
          -  Active nosebleed&#xD;
&#xD;
          -  Recent abdominal surgery or significant abdominal distension&#xD;
&#xD;
          -  Agonal respirations&#xD;
&#xD;
          -  GCS &lt;3&#xD;
&#xD;
          -  Imminent death within the next 1-2hou&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashley Bjorklund, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gulu Regional Referral Hospital</name>
      <address>
        <city>Gulu</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>October 30, 2019</last_update_submitted>
  <last_update_submitted_qc>October 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypoxia</keyword>
  <keyword>Respiratory Distress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02208323
org study id: 1406M51386
secondary id: 12985
nct id: NCT02208323
lead sponsor: 
has dmc: No
This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs to
      fit older children, will create a safe form of respiratory support that may help to decrease
      respiratory distress and thus mortality from pneumonia.
This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs to
      fit older children, will create a safe form of respiratory support that may help to decrease
      respiratory distress and thus mortality from pneumonia. Children age 1 month (mo) to 5 years
      (y) admitted to Gulu Regional Referral Hospital in Gulu, Uganda with respiratory distress
      will be evaluated for use of the modified bCPAP device as treatment for their respiratory
      distress (in addition to their routine care, i.e. antibiotics, nutrition support)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: determine if a modified bCPAP device with an adapted nasal cannula can be used safely in children outside of the neonatal period
time frame: 28 days
description: A composite of potential adverse events that could be attributable to bCPAP use. Adverse events such as nasal erosion, nosebleed, and aerophagia will be graded on a scale
measure: show decreased mortality in patients treated with a modified bCPAP respiratory support device.
time frame: 28 days
description: Comparison of historic mortality data for children admitted with respiratory distress to mortality rate seen during the study. Respiratory distress scores using the TAL score (18) will be recorded prior to therapy and throughout the hospital course
arm group label: Bubble CPAP
arm group type: Experimental
description: Bubble CPAP for 28 days
intervention type: Device
intervention name: Bubble CPAP
description: Respiratory assistance
arm group label: Bubble CPAP
criteria: 
gender: All
minimum age: 1 Month
maximum age: 5 Years
healthy volunteers: No
last name: Ashley Bjorklund, MD
role: Study Director
affiliation: University of Minnesota
facility: 
country: Uganda
responsible party type: Sponsor
mesh term: Hypoxia
sharing ipd: No