<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/NCT02971553</url>
  </required_header>
  <id_info>
    <org_study_id>Upright PEEP</org_study_id>
    <nct_id>NCT02971553</nct_id>
  </id_info>
  <brief_title>PEEP Resuscitation Trial</brief_title>
  <acronym>PEEPrest</acronym>
  <official_title>A Randomised Controlled Trial on Positive End-expiratory Pressure (PEEP) During Resuscitation of Non-breathing Neonates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helse Stavanger HF</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Haydom Lutheran Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Helse Stavanger HF</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Each year, almost 3 million newborn babies die within their first month of life, often as a&#xD;
      consequence of labour complications. Approximately 5% of newborns will not start breathing at&#xD;
      birth and need immediate help. The optimal ventilation strategy with liquid-filled lungs has&#xD;
      not been determined. Animal studies suggest that assisted ventilation with positive end&#xD;
      expiratory pressure (PEEP) improves the aeration of liquid-filled lungs leading to more rapid&#xD;
      recovery. However, no large human clinical studies have investigated the clinical responses&#xD;
      to assisted ventilation with PEEP in asphyxiated newborns.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laerdal Global Health has developed a PEEP valve which has been tested and shown to provide&#xD;
      reliable end-expiratory pressures in a manikin model, even with a high mask leak. Whether&#xD;
      this PEEP valve provides reliable PEEP in vivo and whether this translates to clinical&#xD;
      beneficial outcomes remains to be proven.&#xD;
&#xD;
      The aim is to study whether lung aeration can be improved by adding a device for positive end&#xD;
      expiratory pressure (PEEP) to better distend the airways in neonates more than 28 weeks&#xD;
      gestation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">May 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>Delta heart rate (beats/minute) during each ventilation sequence</measure>
    <time_frame>10 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neonatal outcome dead versus alive</measure>
    <time_frame>Up to 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to cessation of ventilation</measure>
    <time_frame>Up to 1 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to heart rate above 140 beats/minute</measure>
    <time_frame>Up to 1 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean ariway pressures given</measure>
    <time_frame>Up to 1 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to detection of exhaled CO2 above 1% and 4%</measure>
    <time_frame>Up to 1 hour</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">330</enrollment>
  <condition>Newborn Resuscitation</condition>
  <arm_group>
    <arm_group_label>Upright Resuscitator with PEEP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ventilation with the Upright Resuscitator with PEEP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Upright Resuscitator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ventilation with the Upright Resuscitator (without PEEP)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Upright Resuscitator with PEEP</intervention_name>
    <arm_group_label>Upright Resuscitator with PEEP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Upright Resuscitator</intervention_name>
    <arm_group_label>Upright Resuscitator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neonates who need assisted bag/mask ventilation after birth due to failure to initiate&#xD;
             breathing the first 60 seconds after birth.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Babies with major deformities not deemed to be viable.&#xD;
&#xD;
          -  Missing parental consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hussein Kidanto, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Muhimibili National Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Haydom Lutheran Hospital, Research Institute</name>
      <address>
        <city>Haydom</city>
        <state>Manyara</state>
        <zip>9041</zip>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tanzania</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>June 11, 2019</last_update_submitted>
  <last_update_submitted_qc>June 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02971553
org study id: Upright PEEP
nct id: NCT02971553
lead sponsor: 
collaborator: 
has dmc: Yes
Each year, almost 3 million newborn babies die within their first month of life, often as a
      consequence of labour complications. Approximately 5% of newborns will not start breathing at
      birth and need immediate help. The optimal ventilation strategy with liquid-filled lungs has
      not been determined. Animal studies suggest that assisted ventilation with positive end
      expiratory pressure (PEEP) improves the aeration of liquid-filled lungs leading to more rapid
      recovery. However, no large human clinical studies have investigated the clinical responses
      to assisted ventilation with PEEP in asphyxiated newborns.
Laerdal Global Health has developed a PEEP valve which has been tested and shown to provide
      reliable end-expiratory pressures in a manikin model, even with a high mask leak. Whether
      this PEEP valve provides reliable PEEP in vivo and whether this translates to clinical
      beneficial outcomes remains to be proven.

      The aim is to study whether lung aeration can be improved by adding a device for positive end
      expiratory pressure (PEEP) to better distend the airways in neonates more than 28 weeks
      gestation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Delta heart rate (beats/minute) during each ventilation sequence
time frame: 10 minutes
measure: Neonatal outcome dead versus alive
time frame: Up to 24 hours
measure: Time to cessation of ventilation
time frame: Up to 1 hour
measure: Time to heart rate above 140 beats/minute
time frame: Up to 1 hour
measure: Mean ariway pressures given
time frame: Up to 1 hour
measure: Time to detection of exhaled CO2 above 1% and 4%
time frame: Up to 1 hour
arm group label: Upright Resuscitator with PEEP
arm group type: Experimental
description: Ventilation with the Upright Resuscitator with PEEP
arm group label: Upright Resuscitator
arm group type: Active Comparator
description: Ventilation with the Upright Resuscitator (without PEEP)
intervention type: Device
intervention name: Upright Resuscitator with PEEP
arm group label: Upright Resuscitator with PEEP
intervention type: Device
intervention name: Upright Resuscitator
arm group label: Upright Resuscitator
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Hussein Kidanto, MD, PhD
role: Principal Investigator
affiliation: Muhimibili National Hospital
facility: 
country: Tanzania
responsible party type: Sponsor
sharing ipd: No