<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/NCT03780842</url>
  </required_header>
  <id_info>
    <org_study_id>Pilot breakpoint NAVA</org_study_id>
    <nct_id>NCT03780842</nct_id>
  </id_info>
  <brief_title>Effect of Changing Levels of Neurally Adjusted Ventilatory Assist (NAVA) in Newborns</brief_title>
  <official_title>Effect of Changing Levels of Neurally Adjusted Ventilatory Assist (NAVA) on Respiratory Parameters in Newborns Receiving NAVA Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Julie Lefevere</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitair Ziekenhuis Brussel</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      To examine the effect of changing levels of support during NAVA-ventilation (&quot;NAVA-level&quot;) on&#xD;
      electrical diaphragm activity of the newborn on invasive or non-invasive NAVA ventilation.&#xD;
&#xD;
      The aim is to explore whether a so-called 'breakpoint', as defined in previous studies on&#xD;
      NAVA ventilation in adults and children(1, 9), can be determined in newborn infants.&#xD;
      Knowledge of this breakpoint will be used to optimise the settings of NAVA level at&#xD;
      initiation of invasive or non-invasive NAVA ventilation.&#xD;
&#xD;
      This is an explorative study conducted in preparation of a randomized controlled trial that&#xD;
      is planned in the near future to compare the effects of non-invasive NAVA with nasal&#xD;
      continuous positive airway pressure (CPAP) in newborn infants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2018</start_date>
  <completion_date type="Actual">February 28, 2022</completion_date>
  <primary_completion_date type="Actual">November 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Prospective, interventional, exploratory study in a convenience sample</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Optimal NAVA level to unload the diaphragm</measure>
    <time_frame>24 minutes</time_frame>
    <description>The aim is to explore whether a so-called 'breakpoint', as defined in previous studies on NAVA ventilation in adults and children(1, 9), can be determined in newborn infants. Knowledge of this breakpoint will be used to optimise the settings of NAVA level at initiation of invasive or non-invasive NAVA ventilation.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Newborn Morbidity</condition>
  <arm_group>
    <arm_group_label>Invasive NAVA ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A titration protocol will be used for changing NAVA levels in intubated newborns</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-invasive NAVA ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A titration protocol will be used for changing NAVA levels in newborns with non-invasive NAVA ventilation (= with a nasal interface).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NAVA level</intervention_name>
    <description>A titration protocol will be used for changing NAVA levels. The NAVA level will be reduced to 0,5 cmH2O/µV for 3 minutes as a starting point. Limit peak pressure will be set to 35cmH2O (i.e. according to the standard manufacturer's settings) the maximum pressure that can be delivered to the patient is cut off at 30cmH2O). Other ventilator settings will be left unchanged and are as clinically indicated. Ventilator settings will be according to our standard of care and as following: PEEP between 4 and 7 mmHg, apnea time 2-5 sec, back-up ventilation with a pressure above PEEP between 5 and 15 mmHg and a frequency between 30 and 50 per minute.&#xD;
Starting from a NAVA level of 0,5 cmH20/µV the level will be increased by 0,5 cmH2O/µV every 3 minutes until reaching a maximum NAVA level of 4,0 cmH2O/µV.</description>
    <arm_group_label>Invasive NAVA ventilation</arm_group_label>
    <arm_group_label>Non-invasive NAVA ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newborns admitted to the NICU in need for respiratory support and put on invasive or&#xD;
             non-invasive NAVA by the attending physician. Patients will be included when they are&#xD;
             clinically stable and within 24h after starting NAVA or nivNAVA.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Congenital malformations of the diaphragm or respiratory system, including&#xD;
             congenital diaphragmatic hernia.&#xD;
&#xD;
          -  Patients with abnormalities of the upper airway (e.g. vocal cord paralysis,&#xD;
             post-extubation laryngeal edema, Pierre-Robin sequence…).&#xD;
&#xD;
          -  More than 20% of time spent in back-up ventilationWhen a patient on NAVA ventilation&#xD;
             is apneic for a certain period of time (apnea time), the ventilator switches tot&#xD;
             backup-ventilation. Backup-ventilation is pressure controlled, the apnea time can&#xD;
             variate between 2 and 10 seconds.&#xD;
&#xD;
          -  Clinically unstable patients:&#xD;
&#xD;
          -  hemodynamic instability as defined by need of inotropic support or&#xD;
&#xD;
          -  rapid respiratory deterioration on NAVA ventilation.&#xD;
&#xD;
          -  No informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>20 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Jette</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universitair Ziekenhuis Brussel</investigator_affiliation>
    <investigator_full_name>Julie Lefevere</investigator_full_name>
    <investigator_title>Resident</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03780842
org study id: Pilot breakpoint NAVA
nct id: NCT03780842
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To examine the effect of changing levels of support during NAVA-ventilation ("NAVA-level") on
      electrical diaphragm activity of the newborn on invasive or non-invasive NAVA ventilation.

      The aim is to explore whether a so-called 'breakpoint', as defined in previous studies on
      NAVA ventilation in adults and children(1, 9), can be determined in newborn infants.
      Knowledge of this breakpoint will be used to optimise the settings of NAVA level at
      initiation of invasive or non-invasive NAVA ventilation.

      This is an explorative study conducted in preparation of a randomized controlled trial that
      is planned in the near future to compare the effects of non-invasive NAVA with nasal
      continuous positive airway pressure (CPAP) in newborn infants.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Prospective, interventional, exploratory study in a convenience sample
primary purpose: Supportive Care
masking: None (Open Label)
measure: Optimal NAVA level to unload the diaphragm
time frame: 24 minutes
description: The aim is to explore whether a so-called 'breakpoint', as defined in previous studies on NAVA ventilation in adults and children(1, 9), can be determined in newborn infants. Knowledge of this breakpoint will be used to optimise the settings of NAVA level at initiation of invasive or non-invasive NAVA ventilation.
arm group label: Invasive NAVA ventilation
arm group type: Experimental
description: A titration protocol will be used for changing NAVA levels in intubated newborns
arm group label: Non-invasive NAVA ventilation
arm group type: Experimental
description: A titration protocol will be used for changing NAVA levels in newborns with non-invasive NAVA ventilation (= with a nasal interface).
intervention type: Device
intervention name: NAVA level
description: A titration protocol will be used for changing NAVA levels. The NAVA level will be reduced to 0,5 cmH2O/µV for 3 minutes as a starting point. Limit peak pressure will be set to 35cmH2O (i.e. according to the standard manufacturer's settings) the maximum pressure that can be delivered to the patient is cut off at 30cmH2O). Other ventilator settings will be left unchanged and are as clinically indicated. Ventilator settings will be according to our standard of care and as following: PEEP between 4 and 7 mmHg, apnea time 2-5 sec, back-up ventilation with a pressure above PEEP between 5 and 15 mmHg and a frequency between 30 and 50 per minute.
Starting from a NAVA level of 0,5 cmH20/µV the level will be increased by 0,5 cmH2O/µV every 3 minutes until reaching a maximum NAVA level of 4,0 cmH2O/µV.
arm group label: Invasive NAVA ventilation
arm group label: Non-invasive NAVA ventilation
criteria: 
gender: All
minimum age: N/A
maximum age: 20 Weeks
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: Universitair Ziekenhuis Brussel
investigator full name: Julie Lefevere
investigator title: Resident
sharing ipd: Undecided