<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/NCT04408534</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A01183-36</org_study_id>
    <nct_id>NCT04408534</nct_id>
  </id_info>
  <brief_title>Bilevel Noninvasive Ventilation in Infants With Bronchiolitis Presenting With Apnea</brief_title>
  <official_title>Bilevel Noninvasive Ventilation in Infants With Bronchiolitis Presenting With Apnea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This physiological study aims to compare Bilevel Positive Airway Pressure and continuons&#xD;
      positive airway pressure in infants with severe bronchiolitis presenting with apnea&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a cross over randomized study which aims to compare the effect of 2 modes of&#xD;
      noninvasive ventilation on the occurence of central apnea, as measured by electrical activity&#xD;
      of the diaphragm&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Apnea</measure>
    <time_frame>Up to 12 hours</time_frame>
    <description>Number of apnea</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Bronchiolitis</condition>
  <arm_group>
    <arm_group_label>continuous positive airway pressure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive continuous positive airway pressure as a mode of noninvasive ventilation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bilevel positive airway pressure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive bilevel positive airway pressure as a mode of noninvasive ventilation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>mode of noninvasive ventilation</intervention_name>
    <description>administration of during 3 hours each 4 cycles</description>
    <arm_group_label>bilevel positive airway pressure</arm_group_label>
    <arm_group_label>continuous positive airway pressure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children born at gestational age &gt; 36 weeks gestation&#xD;
&#xD;
          -  Ventilated in Non Invasive Ventilation (NIV) for acute bronchiolitis (clinical&#xD;
             criteria of the American Academy of Pediatrics)&#xD;
&#xD;
          -  Having presented at least 1 apnea objectified by the parents or by a health care&#xD;
             professional, as previously described (1), with one or more of the following&#xD;
             characteristics: 1/Associated with bradycardia &lt; 80 / min, 2/Associated with&#xD;
             desaturation &lt; 85% or 3/Duration more than 10 seconds&#xD;
&#xD;
          -  Informed consent signed by at least one of the two parents + oral agreement from the&#xD;
             second parent before the intervention of the study (2nd signature to be collected as&#xD;
             soon as possible)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With chronic respiratory insufficiency requiring home ventilation (NIV or under&#xD;
             long-term oxygen therapy, initiated at least 14 days before the start of the study)&#xD;
&#xD;
          -  Ventilated in NIV for more than 48 hours before inclusion&#xD;
&#xD;
          -  Hemodynamically significant cardiac disease, primary ENT or pulmonary pathology&#xD;
             (malformative or genetic) or neuromuscular pathology&#xD;
&#xD;
          -  Presenting a contraindication of a gastric tube (trauma or recent surgery concerning&#xD;
             the cervical, pharyngeal or esophageal regions, severe coagulation disorders)&#xD;
&#xD;
          -  Patient not affiliated to health care insurance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Days</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 25, 2020</last_update_submitted>
  <last_update_submitted_qc>May 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04408534
org study id: 2020-A01183-36
nct id: NCT04408534
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This physiological study aims to compare Bilevel Positive Airway Pressure and continuons
      positive airway pressure in infants with severe bronchiolitis presenting with apnea
This study is a cross over randomized study which aims to compare the effect of 2 modes of
      noninvasive ventilation on the occurence of central apnea, as measured by electrical activity
      of the diaphragm
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Apnea
time frame: Up to 12 hours
description: Number of apnea
arm group label: continuous positive airway pressure
arm group type: Active Comparator
description: Patients receive continuous positive airway pressure as a mode of noninvasive ventilation
arm group label: bilevel positive airway pressure
arm group type: Experimental
description: Patients receive bilevel positive airway pressure as a mode of noninvasive ventilation
intervention type: Other
intervention name: mode of noninvasive ventilation
description: administration of during 3 hours each 4 cycles
arm group label: bilevel positive airway pressure
arm group label: continuous positive airway pressure
criteria: 
gender: All
minimum age: 3 Days
maximum age: 6 Months
healthy volunteers: No
responsible party type: Sponsor
mesh term: Bronchiolitis
sharing ipd: Undecided