<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/NCT02967549</url>
  </required_header>
  <id_info>
    <org_study_id>KCH16-150</org_study_id>
    <nct_id>NCT02967549</nct_id>
  </id_info>
  <brief_title>Neurally Adjusted Ventilatory Assist vs Proportional Assist Ventilation</brief_title>
  <official_title>Optimisation of Neonatal Ventilation - NAVA vs PAV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>King's College Hospital NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>King's College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to assess whether neurally adjusted ventilatory assist or proportional assist&#xD;
      ventilation is more effective in infants born prematurely with evolving or established&#xD;
      bronchopulmonary dysplasia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite improvements in survival rates of extremely preterm born infants, the incidence of&#xD;
      bronchopulmonary dysplasia (BPD) remains unchanged over the last two decades. As invasive&#xD;
      ventilation is frequently necessary and indeed life saving, numerous ventilator strategies&#xD;
      have been developed to reduce damage to the developing lung. Synchronisation of mechanical&#xD;
      breaths with the patient's respiratory effort offers the theoretical benefit of improving&#xD;
      oxygenation and ventilation, requiring lower ventilator pressures, fewer air leaks and&#xD;
      increased patient comfort.&#xD;
&#xD;
      Recently, novel modes of ventilation have been introduced that aim to improve upon&#xD;
      conventional ventilation. During both proportional assist ventilation (PAV) and&#xD;
      neurally-adjusted ventilatory assist (NAVA), respiratory support is servo-controlled based on&#xD;
      continuous input from the baby's respiratory effort. Both aim to improve synchronization of&#xD;
      the timing of the respiratory cycle and also to vary the level of support offered&#xD;
      breath-to-breath in proportion to the respiratory effort of the patient.&#xD;
&#xD;
      During proportional assist ventilation (PAV), the ventilator can vary inflation pressure in&#xD;
      phase with both volume change and flow change in order to offload both elastic and resistive&#xD;
      components of the work of breathing. We have previously shown that PAV, compared to ACV,&#xD;
      reduces the oxygenation index and improves respiratory muscle strength in infants born&#xD;
      prematurely who remain ventilated at or beyond one week of life .&#xD;
&#xD;
      Neurally adjusted ventilatory assist (NAVA) utilises the electrical activity of the diaphragm&#xD;
      to trigger the ventilator. A modified nasogastric feeding tube with a series of electrodes&#xD;
      allows monitoring of the diaphragmatic electromyogram (Edi). The waveform of the Edi is used&#xD;
      to trigger and control ventilator support. We have recently shown that NAVA compared to ACV&#xD;
      results in a lower oxygenation index in infants born prematurely who remain ventilated at or&#xD;
      beyond one week of life.&#xD;
&#xD;
      Both PAV and NAVA have been shown to have advantages above conventional triggered ventilation&#xD;
      in neonates, but they have not been compared to each other. Our aim is to determine whether&#xD;
      NAVA or PAV is more effective in prematurely born neonates with evolving or established BPD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">August 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oxygenation index</measure>
    <time_frame>2 hours</time_frame>
    <description>Oxygenation index at the end of each period of ventilation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Bronchopulmonary Dysplasia</condition>
  <arm_group>
    <arm_group_label>NAVA then PAV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants randomised to NAVA then PAV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PAV then NAVA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants randomised to PAV then NAVA</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NAVA</intervention_name>
    <description>NAVA delivered by the Servo-n ventilator (Maquet)</description>
    <arm_group_label>NAVA then PAV</arm_group_label>
    <arm_group_label>PAV then NAVA</arm_group_label>
    <other_name>neurally adjusted ventilatory assist</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PAV</intervention_name>
    <description>PAV delivered by the Stephanie ventilator (Stephan)</description>
    <arm_group_label>NAVA then PAV</arm_group_label>
    <arm_group_label>PAV then NAVA</arm_group_label>
    <other_name>Proportional Assist Ventilation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Born at less than 32 weeks gestation&#xD;
&#xD;
          -  ventilated at or beyond one week of life&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  major congenital abnormalities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Week</minimum_age>
    <maximum_age>1 Year</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne Greenough, MD, FRCPCH</last_name>
    <role>Study Director</role>
    <affiliation>King's College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>King's College Hospital</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Hunt KA, Dassios T, Greenough A. Proportional assist ventilation (PAV) versus neurally adjusted ventilator assist (NAVA): effect on oxygenation in infants with evolving or established bronchopulmonary dysplasia. Eur J Pediatr. 2020 Jun;179(6):901-908. doi: 10.1007/s00431-020-03584-w. Epub 2020 Jan 25.</citation>
    <PMID>31980954</PMID>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>September 15, 2021</last_update_submitted>
  <last_update_submitted_qc>September 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchopulmonary Dysplasia</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 28, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT02967549/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02967549
org study id: KCH16-150
nct id: NCT02967549
lead sponsor: 
collaborator: 
has dmc: No
This study aims to assess whether neurally adjusted ventilatory assist or proportional assist
      ventilation is more effective in infants born prematurely with evolving or established
      bronchopulmonary dysplasia
Despite improvements in survival rates of extremely preterm born infants, the incidence of
      bronchopulmonary dysplasia (BPD) remains unchanged over the last two decades. As invasive
      ventilation is frequently necessary and indeed life saving, numerous ventilator strategies
      have been developed to reduce damage to the developing lung. Synchronisation of mechanical
      breaths with the patient's respiratory effort offers the theoretical benefit of improving
      oxygenation and ventilation, requiring lower ventilator pressures, fewer air leaks and
      increased patient comfort.

      Recently, novel modes of ventilation have been introduced that aim to improve upon
      conventional ventilation. During both proportional assist ventilation (PAV) and
      neurally-adjusted ventilatory assist (NAVA), respiratory support is servo-controlled based on
      continuous input from the baby's respiratory effort. Both aim to improve synchronization of
      the timing of the respiratory cycle and also to vary the level of support offered
      breath-to-breath in proportion to the respiratory effort of the patient.

      During proportional assist ventilation (PAV), the ventilator can vary inflation pressure in
      phase with both volume change and flow change in order to offload both elastic and resistive
      components of the work of breathing. We have previously shown that PAV, compared to ACV,
      reduces the oxygenation index and improves respiratory muscle strength in infants born
      prematurely who remain ventilated at or beyond one week of life .

      Neurally adjusted ventilatory assist (NAVA) utilises the electrical activity of the diaphragm
      to trigger the ventilator. A modified nasogastric feeding tube with a series of electrodes
      allows monitoring of the diaphragmatic electromyogram (Edi). The waveform of the Edi is used
      to trigger and control ventilator support. We have recently shown that NAVA compared to ACV
      results in a lower oxygenation index in infants born prematurely who remain ventilated at or
      beyond one week of life.

      Both PAV and NAVA have been shown to have advantages above conventional triggered ventilation
      in neonates, but they have not been compared to each other. Our aim is to determine whether
      NAVA or PAV is more effective in prematurely born neonates with evolving or established BPD.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Oxygenation index
time frame: 2 hours
description: Oxygenation index at the end of each period of ventilation
arm group label: NAVA then PAV
arm group type: Experimental
description: Infants randomised to NAVA then PAV
arm group label: PAV then NAVA
arm group type: Experimental
description: Infants randomised to PAV then NAVA
intervention type: Device
intervention name: NAVA
description: NAVA delivered by the Servo-n ventilator (Maquet)
arm group label: NAVA then PAV
arm group label: PAV then NAVA
other name: neurally adjusted ventilatory assist
intervention type: Device
intervention name: PAV
description: PAV delivered by the Stephanie ventilator (Stephan)
arm group label: NAVA then PAV
arm group label: PAV then NAVA
other name: Proportional Assist Ventilation
criteria: 
gender: All
minimum age: 1 Week
maximum age: 1 Year
healthy volunteers: No
last name: Anne Greenough, MD, FRCPCH
role: Study Director
affiliation: King's College London
facility: 
country: United Kingdom
citation: Hunt KA, Dassios T, Greenough A. Proportional assist ventilation (PAV) versus neurally adjusted ventilator assist (NAVA): effect on oxygenation in infants with evolving or established bronchopulmonary dysplasia. Eur J Pediatr. 2020 Jun;179(6):901-908. doi: 10.1007/s00431-020-03584-w. Epub 2020 Jan 25.
PMID: 31980954
responsible party type: Sponsor
mesh term: Bronchopulmonary Dysplasia
provided document: 