<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/NCT04459429</url>
  </required_header>
  <id_info>
    <org_study_id>Erebouni01Neonatal</org_study_id>
    <nct_id>NCT04459429</nct_id>
  </id_info>
  <brief_title>Effect of Cannula Size on Oxygen Saturation During Nasal High Flow Therapy in Newborns</brief_title>
  <official_title>Effect of Cannula Size on Peripheral Oxygen Saturation During Nasal High Flow Therapy in Neonates With Respiratory Distress</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erebouni Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fisher and Paykel Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Erebouni Medical Center</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>
      Treatment with nasal high flow therapy (NHF) is an increasingly popular method of respiratory&#xD;
      support in newborns.&#xD;
&#xD;
      Safe and effective use of NHF requires selection of an appropriate nasal prong-to-nares ratio&#xD;
      because leak can influence the delivered pressure.&#xD;
&#xD;
      To the best of our knowledge, this is the first study to investigate the effect of using&#xD;
      different NHF cannula size on peripheral oxygen saturation in newborns with respiratory&#xD;
      distress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      NHF will be applied at 8 L/min using the AIRVO 2 through smaller and larger Optiflow nasal&#xD;
      cannula. The study will have a randomized crossover design. The larger or smaller cannula&#xD;
      size will be applied as the first intervention during each experiment. During each&#xD;
      experiment, if the larger cannula is applied first, then the smaller cannula will be applied&#xD;
      second and if the smaller cannula is applied first, then the larger cannula will be applied&#xD;
      second. Each experiment will last for 1.5 hour.&#xD;
&#xD;
        -  During baseline, supplemental oxygen will be added during NHF therapy to keep SpO2 in&#xD;
           normal ranges (90%-94%). When the SpO2 has stabilized then the level of supplemental&#xD;
           oxygen will be set for the entire experiment unless there is a significant change in&#xD;
           SpO2 as determined by the attending consultant.&#xD;
&#xD;
        -  There will be three consecutive 30-min periods of recording during each experiment and&#xD;
           each experiment will last approximately 1.5 hour.&#xD;
&#xD;
        -  Ventilation will be assessed by Respiratory Inductance Plethysmography (Respitrace) and&#xD;
           transcutaneous carbon dioxide and oxygen.&#xD;
&#xD;
        -  Recordings will be made using ADInstruments Powerlab and Labchart software with video&#xD;
           recording of the patient.&#xD;
&#xD;
        -  Routine measurement of heart rate, respiratory rate and oxygen saturations will be&#xD;
           performed as per standard neonatal practice.&#xD;
&#xD;
      The researcher is an experienced neonatal consultant who will be directly observing the baby&#xD;
      throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 26, 2020</start_date>
  <completion_date type="Actual">December 24, 2020</completion_date>
  <primary_completion_date type="Actual">December 24, 2020</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>
    <intervention_model_description>Randomized crossover</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peripheral oxygen saturation (SpO2 )</measure>
    <time_frame>1.5 hour</time_frame>
    <description>The difference in SpO2 between the period of using the larger cannula versus the smaller cannula</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>inspiratory effort</measure>
    <time_frame>1.5 hour</time_frame>
    <description>The difference in inspiratory effort between the period of using the larger cannula versus the smaller cannula</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory rate</measure>
    <time_frame>1.5 hour</time_frame>
    <description>The change in respiratory rate between the period of using the larger cannula versus the smaller cannula</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative minute ventilation</measure>
    <time_frame>1.5 hour</time_frame>
    <description>The difference in relative minute ventilation (inspiratory effort x respiratory rate) during the periods of using the larger cannula versus smaller cannula</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse rate</measure>
    <time_frame>1.5 hour</time_frame>
    <description>The difference in pulse rate between the period of using the larger cannula versus the smaller cannula</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transcutaneous carbon dioxide</measure>
    <time_frame>1.5 hour</time_frame>
    <description>The difference in TcCO2 between the period of using the larger cannula versus the smaller cannula</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transcutaneous oxygen</measure>
    <time_frame>1.5 hour</time_frame>
    <description>The difference in TcO2 between the period of using the larger cannula versus the smaller cannula</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>RDS - Infants</condition>
  <condition>TTN</condition>
  <arm_group>
    <arm_group_label>NHF by smaller cannula</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nasal High Flow will be applied at 8 L/min (AIRVO 2) through the smaller cannula</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NHF by larger cannula</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nasal High Flow will be applied at 8 L/min (AIRVO 2) through the larger cannula</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Change of cannula size</intervention_name>
    <description>During nasal High Flow Therapy with fixed flow of 8 l/min, the cannula size will be changed from smaller-to-larger or larger-to-smaller</description>
    <arm_group_label>NHF by larger cannula</arm_group_label>
    <arm_group_label>NHF by smaller cannula</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Term and near term newborns with respiratory distress receiving treatment with NHF&#xD;
&#xD;
          2. ≤ 48 hours old&#xD;
&#xD;
          3. FiO2 ≥ 0,4&#xD;
&#xD;
          4. Written parental informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Infants who are clinically unstable and unsuitable for non-invasive respiratory&#xD;
             support as judged by consultant clinician (meet nHF failure criteria).&#xD;
&#xD;
          2. Known major upper airway, lower respiratory tract, cardiac or gastrointestinal tract&#xD;
             anomaly&#xD;
&#xD;
          3. A parent has not given written informed consent to their baby's participation.&#xD;
&#xD;
          4. Prior intubation and/or surfactant administration&#xD;
&#xD;
          5. Known or suspected hypoxic ischemic encephalopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Hour</minimum_age>
    <maximum_age>2 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pavel Mazmanyan, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Erebouni Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Erebouni Medical Center Maternity</name>
      <address>
        <city>Yerevan</city>
        <zip>0087</zip>
        <country>Armenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Armenia</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>June 29, 2021</last_update_submitted>
  <last_update_submitted_qc>June 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erebouni Medical Center</investigator_affiliation>
    <investigator_full_name>Pavel Mazmanyan</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>RDS</keyword>
  <keyword>TTN</keyword>
  <keyword>Nasal High Flow Therapy</keyword>
  <keyword>Newborn</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyaline Membrane Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is currently no intent to share individual data with other researchers.</ipd_description>
  </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/NCT04459429
org study id: Erebouni01Neonatal
nct id: NCT04459429
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Treatment with nasal high flow therapy (NHF) is an increasingly popular method of respiratory
      support in newborns.

      Safe and effective use of NHF requires selection of an appropriate nasal prong-to-nares ratio
      because leak can influence the delivered pressure.

      To the best of our knowledge, this is the first study to investigate the effect of using
      different NHF cannula size on peripheral oxygen saturation in newborns with respiratory
      distress.
NHF will be applied at 8 L/min using the AIRVO 2 through smaller and larger Optiflow nasal
      cannula. The study will have a randomized crossover design. The larger or smaller cannula
      size will be applied as the first intervention during each experiment. During each
      experiment, if the larger cannula is applied first, then the smaller cannula will be applied
      second and if the smaller cannula is applied first, then the larger cannula will be applied
      second. Each experiment will last for 1.5 hour.

        -  During baseline, supplemental oxygen will be added during NHF therapy to keep SpO2 in
           normal ranges (90%-94%). When the SpO2 has stabilized then the level of supplemental
           oxygen will be set for the entire experiment unless there is a significant change in
           SpO2 as determined by the attending consultant.

        -  There will be three consecutive 30-min periods of recording during each experiment and
           each experiment will last approximately 1.5 hour.

        -  Ventilation will be assessed by Respiratory Inductance Plethysmography (Respitrace) and
           transcutaneous carbon dioxide and oxygen.

        -  Recordings will be made using ADInstruments Powerlab and Labchart software with video
           recording of the patient.

        -  Routine measurement of heart rate, respiratory rate and oxygen saturations will be
           performed as per standard neonatal practice.

      The researcher is an experienced neonatal consultant who will be directly observing the baby
      throughout the study.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized crossover
primary purpose: Treatment
masking: None (Open Label)
measure: Peripheral oxygen saturation (SpO2 )
time frame: 1.5 hour
description: The difference in SpO2 between the period of using the larger cannula versus the smaller cannula
measure: inspiratory effort
time frame: 1.5 hour
description: The difference in inspiratory effort between the period of using the larger cannula versus the smaller cannula
measure: Respiratory rate
time frame: 1.5 hour
description: The change in respiratory rate between the period of using the larger cannula versus the smaller cannula
measure: Relative minute ventilation
time frame: 1.5 hour
description: The difference in relative minute ventilation (inspiratory effort x respiratory rate) during the periods of using the larger cannula versus smaller cannula
measure: Pulse rate
time frame: 1.5 hour
description: The difference in pulse rate between the period of using the larger cannula versus the smaller cannula
measure: Transcutaneous carbon dioxide
time frame: 1.5 hour
description: The difference in TcCO2 between the period of using the larger cannula versus the smaller cannula
measure: Transcutaneous oxygen
time frame: 1.5 hour
description: The difference in TcO2 between the period of using the larger cannula versus the smaller cannula
arm group label: NHF by smaller cannula
arm group type: Experimental
description: Nasal High Flow will be applied at 8 L/min (AIRVO 2) through the smaller cannula
arm group label: NHF by larger cannula
arm group type: Experimental
description: Nasal High Flow will be applied at 8 L/min (AIRVO 2) through the larger cannula
intervention type: Device
intervention name: Change of cannula size
description: During nasal High Flow Therapy with fixed flow of 8 l/min, the cannula size will be changed from smaller-to-larger or larger-to-smaller
arm group label: NHF by larger cannula
arm group label: NHF by smaller cannula
criteria: 
gender: All
minimum age: 1 Hour
maximum age: 2 Days
healthy volunteers: No
last name: Pavel Mazmanyan, MD, PhD
role: Principal Investigator
affiliation: Erebouni Medical Center
facility: 
country: Armenia
responsible party type: Principal Investigator
investigator affiliation: Erebouni Medical Center
investigator full name: Pavel Mazmanyan
investigator title: Professor
mesh term: Hyaline Membrane Disease
sharing ipd: No
ipd description: There is currently no intent to share individual data with other researchers.