<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/NCT03250793</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0429</org_study_id>
    <secondary_id>2017-A02270-53</secondary_id>
    <nct_id>NCT03250793</nct_id>
  </id_info>
  <brief_title>Work of Breathing Description in Neonates With Congenital Diaphragmatic Hernia in NAVA and in Conventional Ventilation.</brief_title>
  <acronym>NAVA-DIAPH</acronym>
  <official_title>Physiologic Pilot Study: Work of Breathing Description in Neonates With Congenital Diaphragmatic Hernia in Post-surgical Period Alternatively in Conventional Ventilation (Pressure Controlled) and in NAVA (Neurally Adjusted Ventilatory Assist) Ventilation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      Congenital diaphragmatic hernia (CDH) is a congenital malformation associated with&#xD;
      significant mortality and respiratory morbidity, particularly related to prolonged mechanical&#xD;
      ventilation. NAVA (Neurally Adjusted Ventilatory Assist) is a recent technique that uses the&#xD;
      recognition of the electrical activity of the patient's diaphragm (Edi) and delivers a&#xD;
      synchronized proportional assisted ventilation. This technique has already been used in the&#xD;
      newborn, especially premature and has shown many benefits. Only one study in the literature&#xD;
      shows its feasibility in newborns with CDH. This technique seems interesting in the context&#xD;
      of CDH because it would limit baro-trauma and improve synchronization. Before demonstrating&#xD;
      the clinical benefits, it seems important to describe the effects on the respiratory&#xD;
      physiology, in particular on work of breathing which can be estimated by the esophageal and&#xD;
      trans-diaphragmatic pressure-time product obtained by an esophageal transducer. Our study is&#xD;
      an innovative physiologic pilot study with the objective to describe work of breathing in&#xD;
      neonates with CDH in post-surgical period in NAVA ventilation and in conventional ventilation&#xD;
      using an esophageal transducer. It will provide the clinician with a physiological&#xD;
      justification for the use of NAVA to rapidly improve the respiratory muscular dynamics of&#xD;
      these patients. This study is a prerequisite for the realization of studies demonstrating the&#xD;
      clinical benefit of NAVA ventilation on reduction of duration of ventilation and more&#xD;
      generally on morbidity and mortality in the population of neonate with CDH.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 20, 2018</start_date>
  <completion_date type="Actual">January 20, 2021</completion_date>
  <primary_completion_date type="Actual">January 20, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Work of breathing averaged over 100 consecutive cycles in NAVA ventilation and conventional ventilation</measure>
    <time_frame>in post-surgical period during 6 hours</time_frame>
    <description>Work of breathing is estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient-ventilator synchronization in NAVA</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Comparison of the asynchrony indexes between the 2 modes (Number of asynchronies / Number of respiratory cycles)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-ventilator synchronization in conventional ventilation</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Comparison of the asynchrony indexes between the 2 modes (Number of asynchronies / Number of respiratory cycles)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamic hyperinflation (intrinsic PEEP) in NAVA</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Intrinsic PEEP average over 100 cycles</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamic hyperinflation (intrinsic PEEP) in conventional ventilation.</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Intrinsic PEEP average over 100 cycles</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilation parameters: peak inspiratory pressure in NAVA</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilation parameters: mean pressure in NAVA</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilation parameters: tidal volume in NAVA</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilation parameters: Ti / Ttot ratio in NAVA</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilation parameters: FiO2 in NAVA</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilation parameters: peak inspiratory pressure in conventional ventilation</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilation parameters: mean pressure in conventional ventilation</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilation parameters: tidal volume in conventional ventilation</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilation parameters: Ti / Ttot ratio in conventional ventilation</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilation parameters: FiO2 in conventional ventilation</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physiological parameters indirectly evaluating work of breathing: esophageal swing in NAVA</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Averages of the esophageal and diaphragmatic swings over 100 cycles in each period. Esophageal and diaphragmatic swings are physiological parameters obtained by the esophageal transducer which expressed muscle strength.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in NAVA</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Averages of the esophageal and diaphragmatic swings over 100 cycles in each period. Esophageal and diaphragmatic swings are physiological parameters obtained by the esophageal transducer which expressed muscle strength.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physiological parameters indirectly evaluating work of breathing: esophageal swing in conventional ventilation</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Averages of the esophageal and diaphragmatic swings over 100 cycles in each period. Esophageal and diaphragmatic swings are physiological parameters obtained by the esophageal transducer which expressed muscle strength.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in conventional ventilation</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Averages of the esophageal and diaphragmatic swings over 100 cycles in each period. Esophageal and diaphragmatic swings are physiological parameters obtained by the esophageal transducer which expressed muscle strength.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical parameters of neonates: respiratory rate in NAVA</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical parameters of neonates: heart rate in NAVA</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical parameters of neonates: blood pressure in NAVA</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical parameters of neonates: respiratory rate in conventional ventilation</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical parameters of neonates: heart rate in conventional ventilation</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical parameters of neonates: blood pressure in conventional ventilation</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gas exchange: measurement of transcutaneous SaO2 in NAVA</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evolution of oxygenation parameters (SpO2) and transcutaneous CO2 (pCO2) during each period. SpO2 and pCO2 are measured continuously; average and median will be valued in each period of the study. No blood test will be required.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gas exchange: measurement of transcutaneous pCO2 in NAVA</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evolution of oxygenation parameters (SpO2) and transcutaneous CO2 (pCO2) during each period. SpO2 and pCO2 are measured continuously; average and median will be valued in each period of the study. No blood test will be required.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gas exchange: measurement of transcutaneous pCO2 in conventional ventilation</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evolution of oxygenation parameters (SpO2) and transcutaneous CO2 (pCO2) during each period. SpO2 and pCO2 are measured continuously; average and median will be valued in each period of the study. No blood test will be required.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gas exchange: measurement of transcutaneous SaO2 in conventional ventilation</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evolution of oxygenation parameters (SpO2) and transcutaneous CO2 (pCO2) during each period. SpO2 and pCO2 are measured continuously; average and median will be valued in each period of the study. No blood test will be required.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonate comfort scores: COMFORT-BEHAVIOR score in NAVA</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evaluation of comfort (COMFORT-BEHAVIOR scale) at the beginning and at the end of each period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonate comfort scores: COMFORT-BEHAVIOR score in conventional ventilation</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evaluation of comfort (COMFORT-BEHAVIOR scale) at the beginning and at the end of each period.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Hernia, DIaphragmatic, Congenital</condition>
  <arm_group>
    <arm_group_label>Neonate with congenital diaphragmatic hernia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neonates with congenital diaphragmatic hernia in post-surgical period under mechanical ventilation during weaning of mechanical ventilation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Physiologic study measuring work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer</intervention_name>
    <description>While the patient is under respiratory assistance on the SERVO-I respirator, he will be included in the study and one esophageal transducer of 2,3 mm of diameter will be inserted through the mouth / nose in addition to NAVA's naso / Oro-Gastric tube( Edi Catheter, 6Fr, 49 cm, PHT free 5 pcs / pkg or Catheter Edi, 6Fr, 50 cm, PHT free 5 pcs / pkg). Measurements will be performed using the esophageal transducer under two conditions: 2 hours in conventional ventilation (pressure controlled), 2 hours in NAVA ventilation and then again 2 hours in conventional ventilation (PC) for a total duration of 6 hours.The parameters of conventional ventilation will be left free at the choice of the neonatologist and will be identical between the two periods of conventional ventilation. The initial NAVA level will be defined by the neonatologist using pre-visualization curves. All signals will be recorded via an amplification and acquisition system. Values will be averaged over 100 cycles.</description>
    <arm_group_label>Neonate with congenital diaphragmatic hernia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neonate admitted to neonatal intensive care beyond 34 weeks of amenorrhea&#xD;
&#xD;
          -  With a diagnosis of congenital diaphragmatic hernia having undergone a repair surgery.&#xD;
&#xD;
          -  Necessary invasive ventilatory support by conventional ventilation&#xD;
&#xD;
          -  Informed and signed consent of parents (and / or holders of parental authority)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of parents (and / or holders of parental authority) to participate in the&#xD;
             study&#xD;
&#xD;
          -  Contra-indication to the use of an oro or naso-gastric tube (oesophageal surgery)&#xD;
&#xD;
          -  Child at risk of poor tolerance to the placement of the oesophageal pressure&#xD;
             transducer (history of discomfort when placing a tube, weight &lt;1500g)&#xD;
&#xD;
          -  Central or neuromuscular neurological pathology which may affect respiratory control&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lélia Dreyfus, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>January 20, 2021</last_update_submitted>
  <last_update_submitted_qc>January 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hernia, DIaphragmatic, Congenital</keyword>
  <keyword>Respiration, Artificial</keyword>
  <keyword>physiologic pilot study</keyword>
  <keyword>NAVA</keyword>
  <keyword>Neurally Adjusted Ventilatory Assist</keyword>
  <keyword>esophageal transducer</keyword>
  <keyword>Work of Breathing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernias, Diaphragmatic, Congenital</mesh_term>
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Diaphragmatic</mesh_term>
  </condition_browse>
  <!-- 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/NCT03250793
org study id: 69HCL17_0429
secondary id: 2017-A02270-53
nct id: NCT03250793
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Congenital diaphragmatic hernia (CDH) is a congenital malformation associated with
      significant mortality and respiratory morbidity, particularly related to prolonged mechanical
      ventilation. NAVA (Neurally Adjusted Ventilatory Assist) is a recent technique that uses the
      recognition of the electrical activity of the patient's diaphragm (Edi) and delivers a
      synchronized proportional assisted ventilation. This technique has already been used in the
      newborn, especially premature and has shown many benefits. Only one study in the literature
      shows its feasibility in newborns with CDH. This technique seems interesting in the context
      of CDH because it would limit baro-trauma and improve synchronization. Before demonstrating
      the clinical benefits, it seems important to describe the effects on the respiratory
      physiology, in particular on work of breathing which can be estimated by the esophageal and
      trans-diaphragmatic pressure-time product obtained by an esophageal transducer. Our study is
      an innovative physiologic pilot study with the objective to describe work of breathing in
      neonates with CDH in post-surgical period in NAVA ventilation and in conventional ventilation
      using an esophageal transducer. It will provide the clinician with a physiological
      justification for the use of NAVA to rapidly improve the respiratory muscular dynamics of
      these patients. This study is a prerequisite for the realization of studies demonstrating the
      clinical benefit of NAVA ventilation on reduction of duration of ventilation and more
      generally on morbidity and mortality in the population of neonate with CDH.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Work of breathing averaged over 100 consecutive cycles in NAVA ventilation and conventional ventilation
time frame: in post-surgical period during 6 hours
description: Work of breathing is estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer
measure: Patient-ventilator synchronization in NAVA
time frame: through study completion, an average of 1 year
description: Comparison of the asynchrony indexes between the 2 modes (Number of asynchronies / Number of respiratory cycles)
measure: Patient-ventilator synchronization in conventional ventilation
time frame: through study completion, an average of 1 year
description: Comparison of the asynchrony indexes between the 2 modes (Number of asynchronies / Number of respiratory cycles)
measure: Dynamic hyperinflation (intrinsic PEEP) in NAVA
time frame: through study completion, an average of 1 year
description: Intrinsic PEEP average over 100 cycles
measure: Dynamic hyperinflation (intrinsic PEEP) in conventional ventilation.
time frame: through study completion, an average of 1 year
description: Intrinsic PEEP average over 100 cycles
measure: Ventilation parameters: peak inspiratory pressure in NAVA
time frame: through study completion, an average of 1 year
description: Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
measure: Ventilation parameters: mean pressure in NAVA
time frame: through study completion, an average of 1 year
description: Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
measure: Ventilation parameters: tidal volume in NAVA
time frame: through study completion, an average of 1 year
description: Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
measure: Ventilation parameters: Ti / Ttot ratio in NAVA
time frame: through study completion, an average of 1 year
description: Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
measure: Ventilation parameters: FiO2 in NAVA
time frame: through study completion, an average of 1 year
description: Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
measure: Ventilation parameters: peak inspiratory pressure in conventional ventilation
time frame: through study completion, an average of 1 year
description: Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
measure: Ventilation parameters: mean pressure in conventional ventilation
time frame: through study completion, an average of 1 year
description: Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
measure: Ventilation parameters: tidal volume in conventional ventilation
time frame: through study completion, an average of 1 year
description: Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
measure: Ventilation parameters: Ti / Ttot ratio in conventional ventilation
time frame: through study completion, an average of 1 year
description: Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
measure: Ventilation parameters: FiO2 in conventional ventilation
time frame: through study completion, an average of 1 year
description: Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
measure: Physiological parameters indirectly evaluating work of breathing: esophageal swing in NAVA
time frame: through study completion, an average of 1 year
description: Averages of the esophageal and diaphragmatic swings over 100 cycles in each period. Esophageal and diaphragmatic swings are physiological parameters obtained by the esophageal transducer which expressed muscle strength.
measure: Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in NAVA
time frame: through study completion, an average of 1 year
description: Averages of the esophageal and diaphragmatic swings over 100 cycles in each period. Esophageal and diaphragmatic swings are physiological parameters obtained by the esophageal transducer which expressed muscle strength.
measure: Physiological parameters indirectly evaluating work of breathing: esophageal swing in conventional ventilation
time frame: through study completion, an average of 1 year
description: Averages of the esophageal and diaphragmatic swings over 100 cycles in each period. Esophageal and diaphragmatic swings are physiological parameters obtained by the esophageal transducer which expressed muscle strength.
measure: Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in conventional ventilation
time frame: through study completion, an average of 1 year
description: Averages of the esophageal and diaphragmatic swings over 100 cycles in each period. Esophageal and diaphragmatic swings are physiological parameters obtained by the esophageal transducer which expressed muscle strength.
measure: Clinical parameters of neonates: respiratory rate in NAVA
time frame: through study completion, an average of 1 year
description: Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
measure: Clinical parameters of neonates: heart rate in NAVA
time frame: through study completion, an average of 1 year
description: Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
measure: Clinical parameters of neonates: blood pressure in NAVA
time frame: through study completion, an average of 1 year
description: Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
measure: Clinical parameters of neonates: respiratory rate in conventional ventilation
time frame: through study completion, an average of 1 year
description: Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
measure: Clinical parameters of neonates: heart rate in conventional ventilation
time frame: through study completion, an average of 1 year
description: Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
measure: Clinical parameters of neonates: blood pressure in conventional ventilation
time frame: through study completion, an average of 1 year
description: Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
measure: Gas exchange: measurement of transcutaneous SaO2 in NAVA
time frame: through study completion, an average of 1 year
description: Evolution of oxygenation parameters (SpO2) and transcutaneous CO2 (pCO2) during each period. SpO2 and pCO2 are measured continuously; average and median will be valued in each period of the study. No blood test will be required.
measure: Gas exchange: measurement of transcutaneous pCO2 in NAVA
time frame: through study completion, an average of 1 year
description: Evolution of oxygenation parameters (SpO2) and transcutaneous CO2 (pCO2) during each period. SpO2 and pCO2 are measured continuously; average and median will be valued in each period of the study. No blood test will be required.
measure: Gas exchange: measurement of transcutaneous pCO2 in conventional ventilation
time frame: through study completion, an average of 1 year
description: Evolution of oxygenation parameters (SpO2) and transcutaneous CO2 (pCO2) during each period. SpO2 and pCO2 are measured continuously; average and median will be valued in each period of the study. No blood test will be required.
measure: Gas exchange: measurement of transcutaneous SaO2 in conventional ventilation
time frame: through study completion, an average of 1 year
description: Evolution of oxygenation parameters (SpO2) and transcutaneous CO2 (pCO2) during each period. SpO2 and pCO2 are measured continuously; average and median will be valued in each period of the study. No blood test will be required.
measure: Neonate comfort scores: COMFORT-BEHAVIOR score in NAVA
time frame: through study completion, an average of 1 year
description: Evaluation of comfort (COMFORT-BEHAVIOR scale) at the beginning and at the end of each period.
measure: Neonate comfort scores: COMFORT-BEHAVIOR score in conventional ventilation
time frame: through study completion, an average of 1 year
description: Evaluation of comfort (COMFORT-BEHAVIOR scale) at the beginning and at the end of each period.
arm group label: Neonate with congenital diaphragmatic hernia
arm group type: Experimental
description: Neonates with congenital diaphragmatic hernia in post-surgical period under mechanical ventilation during weaning of mechanical ventilation
intervention type: Device
intervention name: Physiologic study measuring work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer
description: While the patient is under respiratory assistance on the SERVO-I respirator, he will be included in the study and one esophageal transducer of 2,3 mm of diameter will be inserted through the mouth / nose in addition to NAVA's naso / Oro-Gastric tube( Edi Catheter, 6Fr, 49 cm, PHT free 5 pcs / pkg or Catheter Edi, 6Fr, 50 cm, PHT free 5 pcs / pkg). Measurements will be performed using the esophageal transducer under two conditions: 2 hours in conventional ventilation (pressure controlled), 2 hours in NAVA ventilation and then again 2 hours in conventional ventilation (PC) for a total duration of 6 hours.The parameters of conventional ventilation will be left free at the choice of the neonatologist and will be identical between the two periods of conventional ventilation. The initial NAVA level will be defined by the neonatologist using pre-visualization curves. All signals will be recorded via an amplification and acquisition system. Values will be averaged over 100 cycles.
arm group label: Neonate with congenital diaphragmatic hernia
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: No
last name: Lélia Dreyfus, MD
role: Principal Investigator
affiliation: Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon
facility: 
country: France
responsible party type: Sponsor
mesh term: Hernias, Diaphragmatic, Congenital
mesh term: Hernia
mesh term: Hernia, Diaphragmatic