<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/NCT04404816</url>
  </required_header>
  <id_info>
    <org_study_id>072015</org_study_id>
    <nct_id>NCT04404816</nct_id>
  </id_info>
  <brief_title>Effects of Non-invasive Ventilation With Helium-oxygen Mixture in Premature Infants With Respiratory Distress Syndrome</brief_title>
  <official_title>Effects of Non-invasive Ventilation With Helium-oxygen Mixture in Premature Infants With Respiratory Distress Syndrome on Pulmonary Function and Electric Activity of the Diaphragm</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poznan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Society for Paediatric Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Poznan University of Medical Sciences</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>
      The use of a mixture of helium with oxygen (heliox) as a breathing gas may be beneficial due&#xD;
      to its unique physical properties, such as low density and high carbon dioxide (CO2)&#xD;
      diffusion coefficient. In previous studies in neonates with respiratory failure, conventional&#xD;
      ventilation with heliox was associated with improved oxygenation and selected respiratory&#xD;
      parameters. The use of heliox may increase the effectiveness of intermittent nasal positive&#xD;
      pressure ventilation (NIPPV), but knowledge about the effects of such therapy on newborns is&#xD;
      limited.The use of non- invasive neurally adjusted ventilatory assist (NIV-NAVA) allows&#xD;
      synchronization and assessment of electrical activity of the diaphragm (EaDI) during heliox&#xD;
      administration in premature babies with respiratory failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim of the study was to assess of the impact of non-invasive ventilation with heliox on&#xD;
      respiratory function, diaphragm bioelectrical activity, cerebral oxygenation and selected&#xD;
      vital signs in premature neonates with respiratory failure. 23 neonates ≤32 weeks gestational&#xD;
      age (GA) were enrolled in the study. Patients were eligible for inclusion when ventilated due&#xD;
      to respiratory failure, and in group 1 (n=12) on NIV as primary modality with oxygen&#xD;
      requirement of 0.25-0.4 in the first 72 hours of life, or in group 2 (n=11) ready to extubate&#xD;
      according to the given criteria. Newborns were ventilated with NIV NAVA and standard&#xD;
      breathing gas (air-oxygen) at baseline. Heliox was introduced for 3 hours, followed by 3&#xD;
      hours of air-oxygen. NAVA level was kept constant and pulse oximeter oxygen saturation (SpO2)&#xD;
      kept in range of 90-95%. Recorded parameters included heart rate (HR), SpO2 and cerebral&#xD;
      tissue oxygenation (StO2). Selected ventilation parameters: peak inspiratory pressure (PIP),&#xD;
      positive end-expiratory pressure (PEEP), mean airway pressure (MAP), air leakage during NIV,&#xD;
      fraction of inspired oxygen (FiO2) as well as electrical activity of the diaphragm (EaDI&#xD;
      mean, minimum and maximum) were also acquired. Blood gas analysis was performed in each&#xD;
      period of the study. Statistical analysis was completed with ANOVA Friedman's test and&#xD;
      single-factor repeated-measures analysis of variance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>baseline minimal electric activity of the diaphragm (EaDI min)</measure>
    <time_frame>measured at baseline</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI min [mcV, microvolts] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>baseline mean electric activity of the diaphragm (EaDI mean)</measure>
    <time_frame>measured at baseline</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>baseline maximal electric activity of the diaphragm (EaDI max)</measure>
    <time_frame>measured at baseline</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>minimal electric activity of the diaphragm (EaDI min) after 15 minutes of heliox</measure>
    <time_frame>measured after 15 minutes of heliox ventilation</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mean electric activity of the diaphragm (EaDI mean) after 15 minutes of heliox</measure>
    <time_frame>measured after 15 minutes of heliox ventilation</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>maximal electric activity of the diaphragm (EaDI max) after 15 minutes of heliox</measure>
    <time_frame>measured after 15 minutes of heliox ventilation</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>minimal electric activity of the diaphragm (EaDI min) after 60 minutes of heliox</measure>
    <time_frame>measured after 60 minutes of heliox ventilation</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mean electric activity of the diaphragm (EaDI mean) after 60 minutes of heliox</measure>
    <time_frame>measured after 60 minutes of heliox ventilation</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>maximal electric activity of the diaphragm (EaDI max) after 60 minutes of heliox</measure>
    <time_frame>measured after 60 minutes of heliox ventilation</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>minimal electric activity of the diaphragm (EaDI min) after 180 minutes of heliox</measure>
    <time_frame>measured after 180 minutes of heliox ventilation</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mean electric activity of the diaphragm (EaDI mean) after 180 minutes of heliox</measure>
    <time_frame>measured after 180 minutes of heliox ventilation</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>maximal electric activity of the diaphragm (EaDI max) after 180 minutes of heliox</measure>
    <time_frame>measured after 180 minutes of heliox ventilation</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>minimal electric activity of the diaphragm (EaDI min) after 15 minutes of standard mixture</measure>
    <time_frame>measured after 15 minutes since the return to ventilation with standard mixture</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mean electric activity of the diaphragm (EaDI mean) after 15 minutes of standard mixture</measure>
    <time_frame>measured after 15 minutes since the return to ventilation with standard mixture</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>maximal electric activity of the diaphragm (EaDI max) after 15 minutes of standard mixture</measure>
    <time_frame>measured after 15 minutes since the return to ventilation with standard mixture</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>minimal electric activity of the diaphragm (EaDI min) after 60 minutes of standard mixture</measure>
    <time_frame>measured after 60 minutes since the return to ventilation with standard mixture</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mean electric activity of the diaphragm (EaDI mean) after 60 minutes of standard mixture</measure>
    <time_frame>measured after 60 minutes since the return to ventilation with standard mixture</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>maximal electric activity of the diaphragm (EaDI max) after 60 minutes of standard mixture</measure>
    <time_frame>measured after 60 minutes since the return to ventilation with standard mixture</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>minimal electric activity of the diaphragm (EaDI min) after 180 minutes of standard mixture</measure>
    <time_frame>measured after 180 minutes since the return to ventilation with standard mixture</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mean electric activity of the diaphragm (EaDI mean) after 180 minutes of standard mixture</measure>
    <time_frame>measured after 180 minutes since the return to ventilation with standard mixture</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>maximal electric activity of the diaphragm (EaDI max) after 180 minutes of standard mixture</measure>
    <time_frame>measured after 180 minutes since the return to ventilation with standard mixture</time_frame>
    <description>Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and &quot;Servo-tracker&quot; software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>baseline PIP (peak inspiratory pressure)</measure>
    <time_frame>measured at baseline</time_frame>
    <description>PIP [cm H2O, centimeters of water] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>baseline PEEP (positive end-expiratory pressure)</measure>
    <time_frame>measured at baseline</time_frame>
    <description>PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>baseline MAP (mean airway pressure)</measure>
    <time_frame>measured at baseline</time_frame>
    <description>MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PIP (peak inspiratory pressure) after 15 minutes of heliox</measure>
    <time_frame>measured after 15 minutes of heliox ventilation</time_frame>
    <description>PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PIP (peak inspiratory pressure) after 60 minutes of heliox</measure>
    <time_frame>measured after 60 minutes of heliox ventilation</time_frame>
    <description>PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PIP (peak inspiratory pressure) after 180 minutes of heliox</measure>
    <time_frame>measured after 180 minutes of heliox ventilation</time_frame>
    <description>PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PIP (peak inspiratory pressure) after 15 minutes of standard mixture</measure>
    <time_frame>measured after 15 minutes since the return to ventilation with standard mixture</time_frame>
    <description>PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PIP (peak inspiratory pressure) after 60 minutes of standard mixture</measure>
    <time_frame>measured after 60 minutes since the return to ventilation with standard mixture</time_frame>
    <description>PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PIP (peak inspiratory pressure) after 180 minutes of standard mixture</measure>
    <time_frame>measured after 180 minutes since the return to ventilation with standard mixture</time_frame>
    <description>PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PEEP (positive end-expiratory pressure) after 15 minutes of heliox</measure>
    <time_frame>measured after 15 minutes of heliox ventilation</time_frame>
    <description>PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PEEP (positive end-expiratory pressure) after 60 minutes of heliox</measure>
    <time_frame>measured after 60 minutes of heliox ventilation</time_frame>
    <description>PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PEEP (positive end-expiratory pressure) after 180 minutes of heliox</measure>
    <time_frame>measured after 180 minutes of heliox ventilation</time_frame>
    <description>PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PEEP (positive end-expiratory pressure) after 15 minutes of standard mixture</measure>
    <time_frame>measured after 15 minutes since the return to ventilation with standard mixture</time_frame>
    <description>PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PEEP (positive end-expiratory pressure) after 60 minutes of standard mixture</measure>
    <time_frame>measured after 60 minutes since the return to ventilation with standard mixture</time_frame>
    <description>PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PEEP (positive end-expiratory pressure) after 180 minutes of standard mixture</measure>
    <time_frame>measured after 180 minutes since the return to ventilation with standard mixture</time_frame>
    <description>PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MAP (mean airway pressure) after 15 minutes of heliox</measure>
    <time_frame>measured after 15 minutes of heliox ventilation</time_frame>
    <description>MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MAP (mean airway pressure) after 60 minutes of heliox</measure>
    <time_frame>measured after 60 minutes of heliox ventilation</time_frame>
    <description>MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MAP (mean airway pressure) after 180 minutes of heliox</measure>
    <time_frame>measured after 180 minutes of heliox ventilation</time_frame>
    <description>MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MAP (mean airway pressure) after 15 minutes of standard ventilation</measure>
    <time_frame>measured after 180 minutes since the return to ventilation with standard mixture</time_frame>
    <description>MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MAP (mean airway pressure) after 60 minutes of standard ventilation</measure>
    <time_frame>measured after 60 minutes since the return to ventilation with standard mixture</time_frame>
    <description>MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MAP (mean airway pressure) after 180 minutes of standard ventilation</measure>
    <time_frame>measured after 180 minutes since the return to ventilation with standard mixture</time_frame>
    <description>MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>baseline NIV leakage</measure>
    <time_frame>measured at baseline</time_frame>
    <description>gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NIV leakage after 15 minutes of heliox</measure>
    <time_frame>measured after 15 minutes of heliox ventilation</time_frame>
    <description>gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NIV leakage after 60 minutes of heliox</measure>
    <time_frame>measured after 60 minutes of heliox ventilation</time_frame>
    <description>gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NIV leakage after 180 minutes of heliox</measure>
    <time_frame>measured after 180 minutes of heliox ventilation</time_frame>
    <description>gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NIV leakage after 15 minutes of standard mixture</measure>
    <time_frame>measured after 15 minutes since the return to ventilation with standard mixture</time_frame>
    <description>gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NIV leakage after 60 minutes of standard mixture</measure>
    <time_frame>measured after 60 minutes since the return to ventilation with standard mixture</time_frame>
    <description>gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NIV leakage after 180 minutes of standard mixture</measure>
    <time_frame>measured after 180 minutes since the return to ventilation with standard mixture</time_frame>
    <description>gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>baseline cerebral oxygenation</measure>
    <time_frame>measured at baseline</time_frame>
    <description>Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral oxygenation after 15 minutes of heliox</measure>
    <time_frame>measured after 15 minutes of heliox ventilation</time_frame>
    <description>Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral oxygenation after 60 minutes of heliox</measure>
    <time_frame>measured after 60 minutes of heliox ventilation</time_frame>
    <description>Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral oxygenation after 180 minutes of heliox</measure>
    <time_frame>measured after 180 minutes of heliox ventilation</time_frame>
    <description>Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral oxygenation after 15 minutes of standard mixture</measure>
    <time_frame>measured after 15 minutes since the return to standard mixture ventilation</time_frame>
    <description>Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral oxygenation after 60 minutes of standard mixture</measure>
    <time_frame>measured after 60 minutes since the return to standard mixture ventilation</time_frame>
    <description>Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral oxygenation after 180 minutes of standard mixture</measure>
    <time_frame>measured after 180 minutes since the return to standard mixture ventilation</time_frame>
    <description>Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>baseline oxygen requirements</measure>
    <time_frame>recorded at baseline</time_frame>
    <description>Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen requirements after 15 minutes of heliox</measure>
    <time_frame>recorded after 15 minutes of heliox ventilation</time_frame>
    <description>Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen requirements after 60 minutes of heliox</measure>
    <time_frame>recorded after 60 minutes of heliox ventilation</time_frame>
    <description>Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen requirements after 180 minutes of heliox</measure>
    <time_frame>recorded after 180 minutes of heliox ventilation</time_frame>
    <description>Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen requirements after 15 minutes of standard ventilation</measure>
    <time_frame>recorded after 15 minutes since the return to standard mixture ventilation</time_frame>
    <description>Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen requirements after 60 minutes of standard ventilation</measure>
    <time_frame>recorded after 60 minutes since the return to standard mixture ventilation</time_frame>
    <description>Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen requirements after 180 minutes of standard ventilation</measure>
    <time_frame>recorded after 180 minutes since the return to standard mixture ventilation</time_frame>
    <description>Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>baseline capillary blood gas analysis</measure>
    <time_frame>blood samples drawn at baseline</time_frame>
    <description>Cobas B 221; Roche, Germany; the values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>capillary blood gas analysis after 3 hours of heliox</measure>
    <time_frame>blood samples drawn after 3 hours of heliox ventilation</time_frame>
    <description>Cobas B 221; Roche, Germany; the values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>capillary blood gas analysis after 3 hours of standard mixture</measure>
    <time_frame>blood samples drawn after 3 hours of standard mixture ventilation</time_frame>
    <description>Cobas B 221; Roche, Germany; the values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>baseline heart rate</measure>
    <time_frame>measured at baseline</time_frame>
    <description>heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate after 15 minutes of heliox</measure>
    <time_frame>measured after 15 minutes of heliox ventilation</time_frame>
    <description>heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate after 60 minutes of heliox</measure>
    <time_frame>measured after 60 minutes of heliox ventilation</time_frame>
    <description>heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate after 180 minutes of heliox</measure>
    <time_frame>measured after 180 minutes of heliox ventilation</time_frame>
    <description>heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate after 15 minutes of standard mixture</measure>
    <time_frame>measured after 15 minutes since the return to standard mixture ventilation</time_frame>
    <description>heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate after 60 minutes of standard mixture</measure>
    <time_frame>measured after 60 minutes since the return to standard mixture ventilation</time_frame>
    <description>heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate after 180 minutes of standard mixture</measure>
    <time_frame>measured after 180 minutes since the return to standard mixture ventilation</time_frame>
    <description>heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>baseline oxygen saturation</measure>
    <time_frame>measured at baseline</time_frame>
    <description>SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen saturation after 15 minutes of heliox</measure>
    <time_frame>measured 15 minutes after heliox ventilation</time_frame>
    <description>SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen saturation after 60 minutes of heliox</measure>
    <time_frame>measured 60 minutes after heliox ventilation</time_frame>
    <description>SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen saturation after 180 minutes of heliox</measure>
    <time_frame>measured 180 minutes after heliox ventilation</time_frame>
    <description>SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen saturation after 15 minutes of standard mixture</measure>
    <time_frame>measured 15 minutes since the return to standard mixture ventilation</time_frame>
    <description>SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen saturation after 60 minutes of standard mixture</measure>
    <time_frame>measured 60 minutes since the return to standard mixture ventilation</time_frame>
    <description>SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen saturation after 180 minutes of standard mixture</measure>
    <time_frame>measured 180 minutes since the return to standard mixture ventilation</time_frame>
    <description>SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Respiratory Distress Syndrome</condition>
  <condition>Premature Infants</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>premature infants born &lt; 33 G.A. enrolled in the first 72 hours after birth, with respiratory distress syndrome, requiring non-invasive ventilation with FiO2 &lt;0.4</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>premature infants born &lt; 33 G.A. with respiratory insufficiency requiring mechanical ventilation, after more than 1 failed extubation attempt</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>heliox</intervention_name>
    <description>NIV-NAVA with a conventional gas mixture (air-oxygen) at baseline, 3 hours of NIV-NAVA with heliox and return to NIV-NAVA with air-oxygen.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <other_name>helium-oxygen gas mixture</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (Group 1):&#xD;
&#xD;
          -  GA under 33 weeks GA&#xD;
&#xD;
          -  Need for NIV due to clinical symptoms of respiratory distress in course of RDS&#xD;
&#xD;
          -  FiO2=0.25-0.4&#xD;
&#xD;
          -  Enrollment within first 72 hours of life&#xD;
&#xD;
          -  Parental consent&#xD;
&#xD;
        Inclusion Criteria (Group 2):&#xD;
&#xD;
          -  GA under 33 weeks GA&#xD;
&#xD;
          -  Need for MV due to clinical symptoms of respiratory distress&#xD;
&#xD;
          -  at least one failed attempted extubation&#xD;
&#xD;
          -  Parental consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major congenital anomalies&#xD;
&#xD;
          -  Deteriorating pulmonary function despite NIV and the need for intubation and&#xD;
             conventional mechanical ventilation (CMV) (Preliminary criteria: pH&lt; 7.22, carbon&#xD;
             dioxide partial pressure (pCO2) &gt;65)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Hour</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tomasz Szczapa, M.D. PhD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Neonatology - Poznan University of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gynecological and obstetric teaching hospital, Departament of Neonatology, Polna street 33</name>
      <address>
        <city>Poznań</city>
        <state>Great Poland</state>
        <zip>60-535</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Halliday HL; European Association of Perinatal Medicine. European consensus guidelines on the management of neonatal respiratory distress syndrome in preterm infants--2013 update. Neonatology. 2013;103(4):353-68. doi: 10.1159/000349928. Epub 2013 May 31.</citation>
    <PMID>23736015</PMID>
  </reference>
  <reference>
    <citation>Elleau C, Galperine RI, Guenard H, Demarquez JL. Helium-oxygen mixture in respiratory distress syndrome: a double-blind study. J Pediatr. 1993 Jan;122(1):132-6. doi: 10.1016/s0022-3476(05)83506-1. Erratum In: J Pediatr 1993 Aug;123(2):336.</citation>
    <PMID>8419600</PMID>
  </reference>
  <reference>
    <citation>Colnaghi M, Pierro M, Migliori C, Ciralli F, Matassa PG, Vendettuoli V, Mercadante D, Consonni D, Mosca F. Nasal continuous positive airway pressure with heliox in preterm infants with respiratory distress syndrome. Pediatrics. 2012 Feb;129(2):e333-8. doi: 10.1542/peds.2011-0532. Epub 2012 Jan 30.</citation>
    <PMID>22291116</PMID>
  </reference>
  <reference>
    <citation>Szczapa T, Gadzinowski J, Moczko J, Merritt TA. Heliox for mechanically ventilated newborns with bronchopulmonary dysplasia. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F128-33. doi: 10.1136/archdischild-2013-303988. Epub 2013 Nov 15.</citation>
    <PMID>24239984</PMID>
  </reference>
  <reference>
    <citation>Szczapa T, Gadzinowski J. Use of heliox in the management of neonates with meconium aspiration syndrome. Neonatology. 2011;100(3):265-70. doi: 10.1159/000327531. Epub 2011 Jun 23.</citation>
    <PMID>21701217</PMID>
  </reference>
  <reference>
    <citation>Jassar RK, Vellanki H, Zhu Y, Hesek A, Wang J, Rodriguez E, Wu J, Shaffer TH, Wolfson MR. High flow nasal cannula (HFNC) with Heliox decreases diaphragmatic injury in a newborn porcine lung injury model. Pediatr Pulmonol. 2014 Dec;49(12):1214-22. doi: 10.1002/ppul.23000. Epub 2014 Feb 5.</citation>
    <PMID>24500982</PMID>
  </reference>
  <reference>
    <citation>Sinderby C, Beck J, Spahija J, Weinberg J, Grassino A. Voluntary activation of the human diaphragm in health and disease. J Appl Physiol (1985). 1998 Dec;85(6):2146-58. doi: 10.1152/jappl.1998.85.6.2146.</citation>
    <PMID>9843538</PMID>
  </reference>
  <reference>
    <citation>Beck J, Reilly M, Grasselli G, Qui H, Slutsky AS, Dunn MS, Sinderby CA. Characterization of neural breathing pattern in spontaneously breathing preterm infants. Pediatr Res. 2011 Dec;70(6):607-13. doi: 10.1203/PDR.0b013e318232100e.</citation>
    <PMID>21857389</PMID>
  </reference>
  <reference>
    <citation>Brooks LJ, DiFiore JM, Martin RJ. Assessment of tidal volume over time in preterm infants using respiratory inductance plethysmography, The CHIME Study Group. Collaborative Home Infant Monitoring Evaluation. Pediatr Pulmonol. 1997 Jun;23(6):429-33. doi: 10.1002/(sici)1099-0496(199706)23:63.0.co;2-d.</citation>
    <PMID>9220525</PMID>
  </reference>
  <reference>
    <citation>Nawab US, Touch SM, Irwin-Sherman T, Blackson TJ, Greenspan JS, Zhu G, Shaffer TH, Wolfson MR. Heliox attenuates lung inflammation and structural alterations in acute lung injury. Pediatr Pulmonol. 2005 Dec;40(6):524-32. doi: 10.1002/ppul.20304.</citation>
    <PMID>16193495</PMID>
  </reference>
  <reference>
    <citation>Kuligowski J, Escobar J, Quintas G, Lliso I, Torres-Cuevas I, Nunez A, Cubells E, Rook D, van Goudoever JB, Vento M. Analysis of lipid peroxidation biomarkers in extremely low gestational age neonate urines by UPLC-MS/MS. Anal Bioanal Chem. 2014 Jul;406(18):4345-56. doi: 10.1007/s00216-014-7824-6. Epub 2014 May 11.</citation>
    <PMID>24817352</PMID>
  </reference>
  <reference>
    <citation>Kuligowski J, Torres-Cuevas I, Quintas G, Rook D, van Goudoever JB, Cubells E, Asensi M, Lliso I, Nunez A, Vento M, Escobar J. Assessment of oxidative damage to proteins and DNA in urine of newborn infants by a validated UPLC-MS/MS approach. PLoS One. 2014 Apr 2;9(4):e93703. doi: 10.1371/journal.pone.0093703. eCollection 2014.</citation>
    <PMID>24695409</PMID>
  </reference>
  <reference>
    <citation>Oei GT, Weber NC, Hollmann MW, Preckel B. Cellular effects of helium in different organs. Anesthesiology. 2010 Jun;112(6):1503-10. doi: 10.1097/ALN.0b013e3181d9cb5e.</citation>
    <PMID>20460992</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 5, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Poznan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Tomasz Szczapa</investigator_full_name>
    <investigator_title>Deputy Head - Department of Neonatology; Head - Neonatal Biophysical Monitoring and Cardiopulmonary Therapies Research Unit</investigator_title>
  </responsible_party>
  <keyword>heliox</keyword>
  <keyword>respiratory distress syndrome (RDS)</keyword>
  <keyword>non-invasive ventilation</keyword>
  <keyword>NIRS</keyword>
  <keyword>EaDI</keyword>
  <keyword>Edi</keyword>
  <keyword>NIV</keyword>
  <keyword>NAVA</keyword>
  <keyword>helium-oxygen</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Syndrome</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/NCT04404816
org study id: 072015
nct id: NCT04404816
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The use of a mixture of helium with oxygen (heliox) as a breathing gas may be beneficial due
      to its unique physical properties, such as low density and high carbon dioxide (CO2)
      diffusion coefficient. In previous studies in neonates with respiratory failure, conventional
      ventilation with heliox was associated with improved oxygenation and selected respiratory
      parameters. The use of heliox may increase the effectiveness of intermittent nasal positive
      pressure ventilation (NIPPV), but knowledge about the effects of such therapy on newborns is
      limited.The use of non- invasive neurally adjusted ventilatory assist (NIV-NAVA) allows
      synchronization and assessment of electrical activity of the diaphragm (EaDI) during heliox
      administration in premature babies with respiratory failure.
Aim of the study was to assess of the impact of non-invasive ventilation with heliox on
      respiratory function, diaphragm bioelectrical activity, cerebral oxygenation and selected
      vital signs in premature neonates with respiratory failure. 23 neonates ≤32 weeks gestational
      age (GA) were enrolled in the study. Patients were eligible for inclusion when ventilated due
      to respiratory failure, and in group 1 (n=12) on NIV as primary modality with oxygen
      requirement of 0.25-0.4 in the first 72 hours of life, or in group 2 (n=11) ready to extubate
      according to the given criteria. Newborns were ventilated with NIV NAVA and standard
      breathing gas (air-oxygen) at baseline. Heliox was introduced for 3 hours, followed by 3
      hours of air-oxygen. NAVA level was kept constant and pulse oximeter oxygen saturation (SpO2)
      kept in range of 90-95%. Recorded parameters included heart rate (HR), SpO2 and cerebral
      tissue oxygenation (StO2). Selected ventilation parameters: peak inspiratory pressure (PIP),
      positive end-expiratory pressure (PEEP), mean airway pressure (MAP), air leakage during NIV,
      fraction of inspired oxygen (FiO2) as well as electrical activity of the diaphragm (EaDI
      mean, minimum and maximum) were also acquired. Blood gas analysis was performed in each
      period of the study. Statistical analysis was completed with ANOVA Friedman's test and
      single-factor repeated-measures analysis of variance.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: baseline minimal electric activity of the diaphragm (EaDI min)
time frame: measured at baseline
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV, microvolts] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: baseline mean electric activity of the diaphragm (EaDI mean)
time frame: measured at baseline
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: baseline maximal electric activity of the diaphragm (EaDI max)
time frame: measured at baseline
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: minimal electric activity of the diaphragm (EaDI min) after 15 minutes of heliox
time frame: measured after 15 minutes of heliox ventilation
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: mean electric activity of the diaphragm (EaDI mean) after 15 minutes of heliox
time frame: measured after 15 minutes of heliox ventilation
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: maximal electric activity of the diaphragm (EaDI max) after 15 minutes of heliox
time frame: measured after 15 minutes of heliox ventilation
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: minimal electric activity of the diaphragm (EaDI min) after 60 minutes of heliox
time frame: measured after 60 minutes of heliox ventilation
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: mean electric activity of the diaphragm (EaDI mean) after 60 minutes of heliox
time frame: measured after 60 minutes of heliox ventilation
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: maximal electric activity of the diaphragm (EaDI max) after 60 minutes of heliox
time frame: measured after 60 minutes of heliox ventilation
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: minimal electric activity of the diaphragm (EaDI min) after 180 minutes of heliox
time frame: measured after 180 minutes of heliox ventilation
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: mean electric activity of the diaphragm (EaDI mean) after 180 minutes of heliox
time frame: measured after 180 minutes of heliox ventilation
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: maximal electric activity of the diaphragm (EaDI max) after 180 minutes of heliox
time frame: measured after 180 minutes of heliox ventilation
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: minimal electric activity of the diaphragm (EaDI min) after 15 minutes of standard mixture
time frame: measured after 15 minutes since the return to ventilation with standard mixture
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: mean electric activity of the diaphragm (EaDI mean) after 15 minutes of standard mixture
time frame: measured after 15 minutes since the return to ventilation with standard mixture
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: maximal electric activity of the diaphragm (EaDI max) after 15 minutes of standard mixture
time frame: measured after 15 minutes since the return to ventilation with standard mixture
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: minimal electric activity of the diaphragm (EaDI min) after 60 minutes of standard mixture
time frame: measured after 60 minutes since the return to ventilation with standard mixture
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: mean electric activity of the diaphragm (EaDI mean) after 60 minutes of standard mixture
time frame: measured after 60 minutes since the return to ventilation with standard mixture
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: maximal electric activity of the diaphragm (EaDI max) after 60 minutes of standard mixture
time frame: measured after 60 minutes since the return to ventilation with standard mixture
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: minimal electric activity of the diaphragm (EaDI min) after 180 minutes of standard mixture
time frame: measured after 180 minutes since the return to ventilation with standard mixture
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: mean electric activity of the diaphragm (EaDI mean) after 180 minutes of standard mixture
time frame: measured after 180 minutes since the return to ventilation with standard mixture
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: maximal electric activity of the diaphragm (EaDI max) after 180 minutes of standard mixture
time frame: measured after 180 minutes since the return to ventilation with standard mixture
description: Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max [mcV] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
measure: baseline PIP (peak inspiratory pressure)
time frame: measured at baseline
description: PIP [cm H2O, centimeters of water] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: baseline PEEP (positive end-expiratory pressure)
time frame: measured at baseline
description: PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: baseline MAP (mean airway pressure)
time frame: measured at baseline
description: MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: PIP (peak inspiratory pressure) after 15 minutes of heliox
time frame: measured after 15 minutes of heliox ventilation
description: PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: PIP (peak inspiratory pressure) after 60 minutes of heliox
time frame: measured after 60 minutes of heliox ventilation
description: PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: PIP (peak inspiratory pressure) after 180 minutes of heliox
time frame: measured after 180 minutes of heliox ventilation
description: PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: PIP (peak inspiratory pressure) after 15 minutes of standard mixture
time frame: measured after 15 minutes since the return to ventilation with standard mixture
description: PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: PIP (peak inspiratory pressure) after 60 minutes of standard mixture
time frame: measured after 60 minutes since the return to ventilation with standard mixture
description: PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: PIP (peak inspiratory pressure) after 180 minutes of standard mixture
time frame: measured after 180 minutes since the return to ventilation with standard mixture
description: PIP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: PEEP (positive end-expiratory pressure) after 15 minutes of heliox
time frame: measured after 15 minutes of heliox ventilation
description: PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: PEEP (positive end-expiratory pressure) after 60 minutes of heliox
time frame: measured after 60 minutes of heliox ventilation
description: PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: PEEP (positive end-expiratory pressure) after 180 minutes of heliox
time frame: measured after 180 minutes of heliox ventilation
description: PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: PEEP (positive end-expiratory pressure) after 15 minutes of standard mixture
time frame: measured after 15 minutes since the return to ventilation with standard mixture
description: PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: PEEP (positive end-expiratory pressure) after 60 minutes of standard mixture
time frame: measured after 60 minutes since the return to ventilation with standard mixture
description: PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: PEEP (positive end-expiratory pressure) after 180 minutes of standard mixture
time frame: measured after 180 minutes since the return to ventilation with standard mixture
description: PEEP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: MAP (mean airway pressure) after 15 minutes of heliox
time frame: measured after 15 minutes of heliox ventilation
description: MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: MAP (mean airway pressure) after 60 minutes of heliox
time frame: measured after 60 minutes of heliox ventilation
description: MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: MAP (mean airway pressure) after 180 minutes of heliox
time frame: measured after 180 minutes of heliox ventilation
description: MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: MAP (mean airway pressure) after 15 minutes of standard ventilation
time frame: measured after 180 minutes since the return to ventilation with standard mixture
description: MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: MAP (mean airway pressure) after 60 minutes of standard ventilation
time frame: measured after 60 minutes since the return to ventilation with standard mixture
description: MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: MAP (mean airway pressure) after 180 minutes of standard ventilation
time frame: measured after 180 minutes since the return to ventilation with standard mixture
description: MAP [cm of water / cm H2O] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
measure: baseline NIV leakage
time frame: measured at baseline
description: gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
measure: NIV leakage after 15 minutes of heliox
time frame: measured after 15 minutes of heliox ventilation
description: gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
measure: NIV leakage after 60 minutes of heliox
time frame: measured after 60 minutes of heliox ventilation
description: gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
measure: NIV leakage after 180 minutes of heliox
time frame: measured after 180 minutes of heliox ventilation
description: gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
measure: NIV leakage after 15 minutes of standard mixture
time frame: measured after 15 minutes since the return to ventilation with standard mixture
description: gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
measure: NIV leakage after 60 minutes of standard mixture
time frame: measured after 60 minutes since the return to ventilation with standard mixture
description: gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
measure: NIV leakage after 180 minutes of standard mixture
time frame: measured after 180 minutes since the return to ventilation with standard mixture
description: gas leakage fraction [%] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
measure: baseline cerebral oxygenation
time frame: measured at baseline
description: Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
measure: Cerebral oxygenation after 15 minutes of heliox
time frame: measured after 15 minutes of heliox ventilation
description: Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
measure: Cerebral oxygenation after 60 minutes of heliox
time frame: measured after 60 minutes of heliox ventilation
description: Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
measure: Cerebral oxygenation after 180 minutes of heliox
time frame: measured after 180 minutes of heliox ventilation
description: Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
measure: Cerebral oxygenation after 15 minutes of standard mixture
time frame: measured after 15 minutes since the return to standard mixture ventilation
description: Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
measure: Cerebral oxygenation after 60 minutes of standard mixture
time frame: measured after 60 minutes since the return to standard mixture ventilation
description: Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
measure: Cerebral oxygenation after 180 minutes of standard mixture
time frame: measured after 180 minutes since the return to standard mixture ventilation
description: Cerebral tissue oxygen saturation (StO2; [%]) measured with near infrared spectroscopy (NIRS) - NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA - their values will be compared between the heliox and air-oxygen NIV.
measure: baseline oxygen requirements
time frame: recorded at baseline
description: Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
measure: oxygen requirements after 15 minutes of heliox
time frame: recorded after 15 minutes of heliox ventilation
description: Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
measure: oxygen requirements after 60 minutes of heliox
time frame: recorded after 60 minutes of heliox ventilation
description: Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
measure: oxygen requirements after 180 minutes of heliox
time frame: recorded after 180 minutes of heliox ventilation
description: Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
measure: oxygen requirements after 15 minutes of standard ventilation
time frame: recorded after 15 minutes since the return to standard mixture ventilation
description: Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
measure: oxygen requirements after 60 minutes of standard ventilation
time frame: recorded after 60 minutes since the return to standard mixture ventilation
description: Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
measure: oxygen requirements after 180 minutes of standard ventilation
time frame: recorded after 180 minutes since the return to standard mixture ventilation
description: Fraction of inspired oxygen (FiO2) will be recorded during heliox and air-oxygen NIV to maintain the saturation assessed by pulse oximetry (SpO2) in 90-95% range; their values will be compared between the phases of the study
measure: baseline capillary blood gas analysis
time frame: blood samples drawn at baseline
description: Cobas B 221; Roche, Germany; the values will be compared between the heliox and air-oxygen NIV.
measure: capillary blood gas analysis after 3 hours of heliox
time frame: blood samples drawn after 3 hours of heliox ventilation
description: Cobas B 221; Roche, Germany; the values will be compared between the heliox and air-oxygen NIV.
measure: capillary blood gas analysis after 3 hours of standard mixture
time frame: blood samples drawn after 3 hours of standard mixture ventilation
description: Cobas B 221; Roche, Germany; the values will be compared between the heliox and air-oxygen NIV.
measure: baseline heart rate
time frame: measured at baseline
description: heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
measure: heart rate after 15 minutes of heliox
time frame: measured after 15 minutes of heliox ventilation
description: heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
measure: heart rate after 60 minutes of heliox
time frame: measured after 60 minutes of heliox ventilation
description: heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
measure: heart rate after 180 minutes of heliox
time frame: measured after 180 minutes of heliox ventilation
description: heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
measure: heart rate after 15 minutes of standard mixture
time frame: measured after 15 minutes since the return to standard mixture ventilation
description: heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
measure: heart rate after 60 minutes of standard mixture
time frame: measured after 60 minutes since the return to standard mixture ventilation
description: heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
measure: heart rate after 180 minutes of standard mixture
time frame: measured after 180 minutes since the return to standard mixture ventilation
description: heart rate (HR, [bpm / beats per minute]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA), values will be compared between the heliox and air-oxygen NIV.
measure: baseline oxygen saturation
time frame: measured at baseline
description: SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.
measure: oxygen saturation after 15 minutes of heliox
time frame: measured 15 minutes after heliox ventilation
description: SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.
measure: oxygen saturation after 60 minutes of heliox
time frame: measured 60 minutes after heliox ventilation
description: SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.
measure: oxygen saturation after 180 minutes of heliox
time frame: measured 180 minutes after heliox ventilation
description: SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.
measure: oxygen saturation after 15 minutes of standard mixture
time frame: measured 15 minutes since the return to standard mixture ventilation
description: SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.
measure: oxygen saturation after 60 minutes of standard mixture
time frame: measured 60 minutes since the return to standard mixture ventilation
description: SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.
measure: oxygen saturation after 180 minutes of standard mixture
time frame: measured 180 minutes since the return to standard mixture ventilation
description: SpO2 (peripheral capillary oxygen saturation, [%]) measured by NONIN Sen Smart Model X-100, Nonin Medical Inc., Plymouth, USA) and the values will be compared between the heliox and air-oxygen NIV.
arm group label: Group 1
arm group type: Experimental
description: premature infants born < 33 G.A. enrolled in the first 72 hours after birth, with respiratory distress syndrome, requiring non-invasive ventilation with FiO2 <0.4
arm group label: Group 2
arm group type: Experimental
description: premature infants born < 33 G.A. with respiratory insufficiency requiring mechanical ventilation, after more than 1 failed extubation attempt
intervention type: Drug
intervention name: heliox
description: NIV-NAVA with a conventional gas mixture (air-oxygen) at baseline, 3 hours of NIV-NAVA with heliox and return to NIV-NAVA with air-oxygen.
arm group label: Group 1
arm group label: Group 2
other name: helium-oxygen gas mixture
criteria: 
gender: All
minimum age: 1 Hour
maximum age: N/A
healthy volunteers: No
last name: Tomasz Szczapa, M.D. PhD
role: Study Director
affiliation: Department of Neonatology - Poznan University of Medical Sciences
facility: 
country: Poland
citation: Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Halliday HL; European Association of Perinatal Medicine. European consensus guidelines on the management of neonatal respiratory distress syndrome in preterm infants--2013 update. Neonatology. 2013;103(4):353-68. doi: 10.1159/000349928. Epub 2013 May 31.
PMID: 23736015
citation: Elleau C, Galperine RI, Guenard H, Demarquez JL. Helium-oxygen mixture in respiratory distress syndrome: a double-blind study. J Pediatr. 1993 Jan;122(1):132-6. doi: 10.1016/s0022-3476(05)83506-1. Erratum In: J Pediatr 1993 Aug;123(2):336.
PMID: 8419600
citation: Colnaghi M, Pierro M, Migliori C, Ciralli F, Matassa PG, Vendettuoli V, Mercadante D, Consonni D, Mosca F. Nasal continuous positive airway pressure with heliox in preterm infants with respiratory distress syndrome. Pediatrics. 2012 Feb;129(2):e333-8. doi: 10.1542/peds.2011-0532. Epub 2012 Jan 30.
PMID: 22291116
citation: Szczapa T, Gadzinowski J, Moczko J, Merritt TA. Heliox for mechanically ventilated newborns with bronchopulmonary dysplasia. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F128-33. doi: 10.1136/archdischild-2013-303988. Epub 2013 Nov 15.
PMID: 24239984
citation: Szczapa T, Gadzinowski J. Use of heliox in the management of neonates with meconium aspiration syndrome. Neonatology. 2011;100(3):265-70. doi: 10.1159/000327531. Epub 2011 Jun 23.
PMID: 21701217
citation: Jassar RK, Vellanki H, Zhu Y, Hesek A, Wang J, Rodriguez E, Wu J, Shaffer TH, Wolfson MR. High flow nasal cannula (HFNC) with Heliox decreases diaphragmatic injury in a newborn porcine lung injury model. Pediatr Pulmonol. 2014 Dec;49(12):1214-22. doi: 10.1002/ppul.23000. Epub 2014 Feb 5.
PMID: 24500982
citation: Sinderby C, Beck J, Spahija J, Weinberg J, Grassino A. Voluntary activation of the human diaphragm in health and disease. J Appl Physiol (1985). 1998 Dec;85(6):2146-58. doi: 10.1152/jappl.1998.85.6.2146.
PMID: 9843538
citation: Beck J, Reilly M, Grasselli G, Qui H, Slutsky AS, Dunn MS, Sinderby CA. Characterization of neural breathing pattern in spontaneously breathing preterm infants. Pediatr Res. 2011 Dec;70(6):607-13. doi: 10.1203/PDR.0b013e318232100e.
PMID: 21857389
citation: Brooks LJ, DiFiore JM, Martin RJ. Assessment of tidal volume over time in preterm infants using respiratory inductance plethysmography, The CHIME Study Group. Collaborative Home Infant Monitoring Evaluation. Pediatr Pulmonol. 1997 Jun;23(6):429-33. doi: 10.1002/(sici)1099-0496(199706)23:63.0.co;2-d.
PMID: 9220525
citation: Nawab US, Touch SM, Irwin-Sherman T, Blackson TJ, Greenspan JS, Zhu G, Shaffer TH, Wolfson MR. Heliox attenuates lung inflammation and structural alterations in acute lung injury. Pediatr Pulmonol. 2005 Dec;40(6):524-32. doi: 10.1002/ppul.20304.
PMID: 16193495
citation: Kuligowski J, Escobar J, Quintas G, Lliso I, Torres-Cuevas I, Nunez A, Cubells E, Rook D, van Goudoever JB, Vento M. Analysis of lipid peroxidation biomarkers in extremely low gestational age neonate urines by UPLC-MS/MS. Anal Bioanal Chem. 2014 Jul;406(18):4345-56. doi: 10.1007/s00216-014-7824-6. Epub 2014 May 11.
PMID: 24817352
citation: Kuligowski J, Torres-Cuevas I, Quintas G, Rook D, van Goudoever JB, Cubells E, Asensi M, Lliso I, Nunez A, Vento M, Escobar J. Assessment of oxidative damage to proteins and DNA in urine of newborn infants by a validated UPLC-MS/MS approach. PLoS One. 2014 Apr 2;9(4):e93703. doi: 10.1371/journal.pone.0093703. eCollection 2014.
PMID: 24695409
citation: Oei GT, Weber NC, Hollmann MW, Preckel B. Cellular effects of helium in different organs. Anesthesiology. 2010 Jun;112(6):1503-10. doi: 10.1097/ALN.0b013e3181d9cb5e.
PMID: 20460992
responsible party type: Principal Investigator
investigator affiliation: Poznan University of Medical Sciences
investigator full name: Tomasz Szczapa
investigator title: Deputy Head - Department of Neonatology; Head - Neonatal Biophysical Monitoring and Cardiopulmonary Therapies Research Unit
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Premature Birth
mesh term: Syndrome
sharing ipd: No