xml: <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/NCT06037083</url>
    </required_header>
    <id_info>
      <org_study_id>2023-8794</org_study_id>
      <nct_id>NCT06037083</nct_id>
    </id_info>
    <brief_title>Post-Extubation Assessment of Clinical Stability in ELBW Infants</brief_title>
    <acronym>PEACE</acronym>
    <official_title>Post-Extubation Assessment of Clinical Stability in Extremely Preterm Infants: The PEACE Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>St. Justine's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</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>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is an observational, proof-of-concept, feasibility study that aims to evaluate the&#xD;
        feasibility of a monitoring system that integrates clinical data, high-resolution waveforms&#xD;
        from the bedside monitor, regional oxygenation (via cerebral and splanchnic near-infrared&#xD;
        spectroscopy), and regional ventilation (via electrical impedance tomography) from 20&#xD;
        extremely low birth weight infants at high-risk of reintubation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary aim of this proof-of-concept study is to evaluate the feasibility and acceptance&#xD;
        of a monitoring system that integrates clinical data and biomedical signals from multiple&#xD;
        modalities in a cohort of extremely preterm infants at high-risk of clinical instability on&#xD;
        non-invasive respiratory support.&#xD;
  &#xD;
        Secondary aims will be to longitudinally describe peripheral oxygen saturation, cerebral&#xD;
        oxygen saturation, splanchnic oxygen saturation and regional lung ventilation in extremely&#xD;
        low birth weight infants with or without reintubation during the 7 days post extubation.&#xD;
  &#xD;
        The application of this multimodal monitoring approach using both clinical and physiological&#xD;
        data during the postextubation period will help by making the assessment of clinical&#xD;
        stability more comprehensive, more objective, more accurate, more standardized, and more&#xD;
        reflective of important end-organ function. Thus, the proposed multimodal monitoring could&#xD;
        lead to more informed decisions about reintubation and more individualized treatment plans&#xD;
        during this critical period, hence potentially leading to better outcomes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment rate</measure>
      <time_frame>168 hours</time_frame>
      <description>To evaluate the time frame needed to recruit patients and percentage of eligible infants recruited</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Consent rate</measure>
      <time_frame>168 hours</time_frame>
      <description>To evaluate the percentage of eligible infants consented</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of the multimodal monitoring approach</measure>
      <time_frame>168 hours</time_frame>
      <description>Acceptability of the multimodal monitoring approach will be evaluated using short anonymous surveys distributed to parents, bedside nurses, and attending clinicians participating in the study.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To describe longitudinal peripheral blood oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation</measure>
      <time_frame>168 hours</time_frame>
      <description>The variable will be longitudinally described and graphically displayed using mean (standard deviation), median (interquartile range), or number (percentage) for the hour pre-extubation and for each 24-hour bin post-extubation, and compared between infants requiring reintubation and those not requiring reintubation during the 7 days after extubation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To describe longitudinal cerebral oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation</measure>
      <time_frame>168 hours</time_frame>
      <description>The variable will be longitudinally described and graphically displayed using mean (standard deviation), median (interquartile range), or number (percentage) for the hour pre-extubation and for each 24-hour bin post-extubation, and compared between infants requiring reintubation and those not requiring reintubation during the 7 days after extubation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To describe longitudinal splanchnic oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation</measure>
      <time_frame>168 hours</time_frame>
      <description>The variable will be longitudinally described and graphically displayed using mean (standard deviation), median (interquartile range), or number (percentage) for the hour pre-extubation and for each 24-hour bin post-extubation. Repeated measures one-way ANOVA or Friedman test will be used to evaluate for differences in the variables over time.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To describe regional lung ventilation from the immediate pre-extubation period until 72-96 hours post-extubation.</measure>
      <time_frame>96 hours</time_frame>
      <description>The variable will be longitudinally described and graphically displayed using mean (standard deviation), median (interquartile range), or number (percentage) for the hour pre-extubation and for each 24-hour bin post-extubation. Repeated measures one-way ANOVA or Friedman test will be used to evaluate for differences in the variables over time.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Extremely Low Birth Weight Infants</condition>
    <arm_group>
      <arm_group_label>20 extremely low birth weight infants</arm_group_label>
      <description>In addition to the standard care, all participants will be monitored using an extra oxygen saturation probe, two near infrared spectroscopy sensors, and an electrical impedance tomography belt. Data will be continuously collected from extubation to 168 hours postextubation</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Oxygen saturation probe</intervention_name>
      <description>The high-accuracy oxygen saturation signal will be continuously acquired for 168 hours post extubation from a separate pulse oximeter (Radical-7®, Masimo ROOT platform, MasimoCorp, Irvine, LA).</description>
      <arm_group_label>20 extremely low birth weight infants</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Near infrared spectroscopy sensors</intervention_name>
      <description>The cerebral and splanchnic regional oxygen saturation signals will be acquired continuously for 168h post extubation using two near infrared spectroscopy sensors (Masimo ROOT platform, MasimoCorp, Irvine, LA), one placed on the forehead for cerebral oxygenation and one on the abdomen (for splanchnic oxygenation).</description>
      <arm_group_label>20 extremely low birth weight infants</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Electrical impedance tomography</intervention_name>
      <description>The regional lung ventilation will be measured using Electrical Impedance Tomography (TIMPEL, USA) at three time points:&#xD;
  From 1 hour pre-extubation to 2 hours post extubation (total 3 hours)&#xD;
  Between 24 and 48 hours post extubation (total 3 hours)&#xD;
  Between 72 and 96 hours post extubation (total 3 hours)</description>
      <arm_group_label>20 extremely low birth weight infants</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          20 extremely low birth weight preterm infants admitted to the neonatal intensive care unit&#xD;
          at the Montreal Children's Hospital.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Birth weight &lt; 1000g and gestational age &lt; 28+0 weeks,&#xD;
  &#xD;
            -  Received mechanical ventilation within the first 72h of life,&#xD;
  &#xD;
            -  Undergoing their first planned extubation within the first 6 weeks of life.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - Congenital anomalies and congenital heart disorders.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>28 Weeks</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Wissam Shalish, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>McGill University Health Center/Montreal Children's hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Wissam Shalish, MD, PhD</last_name>
      <phone>+1(514) 4124452</phone>
      <phone_ext>22341</phone_ext>
      <email>wissam.shalish@mcgill.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>McGill University Health Center</name>
        <address>
          <city>Montreal</city>
          <state>Quebec</state>
          <zip>H4A 3J1</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Wissam Shalish, MD, PhD</last_name>
        <phone>514-412-4400</phone>
        <phone_ext>22341</phone_ext>
        <email>wissam.shalish@mcgill.ca</email>
      </contact>
      <investigator>
        <last_name>Wissam Shalish, MD PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Guilherme Sant'Anna, MD PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Robert E Kearney, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centre Hospitalier Universitaire Sainte-Justine</name>
        <address>
          <city>Montréal</city>
          <state>Quebec</state>
          <zip>H3T 1C5</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Sophie Tremblay, MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
      <investigator_full_name>Wissam Shalish</investigator_full_name>
      <investigator_title>Assistant Professor of Pediatrics, McGill University Neonatologist, Montreal Children's Hospital</investigator_title>
    </responsible_party>
    <keyword>Reintubation</keyword>
    <keyword>Extubation</keyword>
    <keyword>Extremely low birth weight infants</keyword>
    <keyword>Electrical impedance tomography</keyword>
    <keyword>Cerebral and splanchnic oxygenation</keyword>
    <keyword>Near infrared spectroscopy</keyword>
    <keyword>apnea</keyword>
    <keyword>intermittent hypoxia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Birth Weight</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037083
  org study id: 2023-8794
  nct id: NCT06037083
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: Yes
  This is an observational, proof-of-concept, feasibility study that aims to evaluate the
        feasibility of a monitoring system that integrates clinical data, high-resolution waveforms
        from the bedside monitor, regional oxygenation (via cerebral and splanchnic near-infrared
        spectroscopy), and regional ventilation (via electrical impedance tomography) from 20
        extremely low birth weight infants at high-risk of reintubation.
  The primary aim of this proof-of-concept study is to evaluate the feasibility and acceptance
        of a monitoring system that integrates clinical data and biomedical signals from multiple
        modalities in a cohort of extremely preterm infants at high-risk of clinical instability on
        non-invasive respiratory support.
  
        Secondary aims will be to longitudinally describe peripheral oxygen saturation, cerebral
        oxygen saturation, splanchnic oxygen saturation and regional lung ventilation in extremely
        low birth weight infants with or without reintubation during the 7 days post extubation.
  
        The application of this multimodal monitoring approach using both clinical and physiological
        data during the postextubation period will help by making the assessment of clinical
        stability more comprehensive, more objective, more accurate, more standardized, and more
        reflective of important end-organ function. Thus, the proposed multimodal monitoring could
        lead to more informed decisions about reintubation and more individualized treatment plans
        during this critical period, hence potentially leading to better outcomes.
  observational model: Cohort
  time perspective: Prospective
  measure: Recruitment rate
  time frame: 168 hours
  description: To evaluate the time frame needed to recruit patients and percentage of eligible infants recruited
  measure: Consent rate
  time frame: 168 hours
  description: To evaluate the percentage of eligible infants consented
  measure: Acceptability of the multimodal monitoring approach
  time frame: 168 hours
  description: Acceptability of the multimodal monitoring approach will be evaluated using short anonymous surveys distributed to parents, bedside nurses, and attending clinicians participating in the study.
  measure: To describe longitudinal peripheral blood oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation
  time frame: 168 hours
  description: The variable will be longitudinally described and graphically displayed using mean (standard deviation), median (interquartile range), or number (percentage) for the hour pre-extubation and for each 24-hour bin post-extubation, and compared between infants requiring reintubation and those not requiring reintubation during the 7 days after extubation.
  measure: To describe longitudinal cerebral oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation
  time frame: 168 hours
  description: The variable will be longitudinally described and graphically displayed using mean (standard deviation), median (interquartile range), or number (percentage) for the hour pre-extubation and for each 24-hour bin post-extubation, and compared between infants requiring reintubation and those not requiring reintubation during the 7 days after extubation.
  measure: To describe longitudinal splanchnic oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation
  time frame: 168 hours
  description: The variable will be longitudinally described and graphically displayed using mean (standard deviation), median (interquartile range), or number (percentage) for the hour pre-extubation and for each 24-hour bin post-extubation. Repeated measures one-way ANOVA or Friedman test will be used to evaluate for differences in the variables over time.
  measure: To describe regional lung ventilation from the immediate pre-extubation period until 72-96 hours post-extubation.
  time frame: 96 hours
  description: The variable will be longitudinally described and graphically displayed using mean (standard deviation), median (interquartile range), or number (percentage) for the hour pre-extubation and for each 24-hour bin post-extubation. Repeated measures one-way ANOVA or Friedman test will be used to evaluate for differences in the variables over time.
  arm group label: 20 extremely low birth weight infants
  description: In addition to the standard care, all participants will be monitored using an extra oxygen saturation probe, two near infrared spectroscopy sensors, and an electrical impedance tomography belt. Data will be continuously collected from extubation to 168 hours postextubation
  intervention type: Device
  intervention name: Oxygen saturation probe
  description: The high-accuracy oxygen saturation signal will be continuously acquired for 168 hours post extubation from a separate pulse oximeter (Radical-7®, Masimo ROOT platform, MasimoCorp, Irvine, LA).
  arm group label: 20 extremely low birth weight infants
  intervention type: Device
  intervention name: Near infrared spectroscopy sensors
  description: The cerebral and splanchnic regional oxygen saturation signals will be acquired continuously for 168h post extubation using two near infrared spectroscopy sensors (Masimo ROOT platform, MasimoCorp, Irvine, LA), one placed on the forehead for cerebral oxygenation and one on the abdomen (for splanchnic oxygenation).
  arm group label: 20 extremely low birth weight infants
  intervention type: Device
  intervention name: Electrical impedance tomography
  description: The regional lung ventilation will be measured using Electrical Impedance Tomography (TIMPEL, USA) at three time points:
  From 1 hour pre-extubation to 2 hours post extubation (total 3 hours)
  Between 24 and 48 hours post extubation (total 3 hours)
  Between 72 and 96 hours post extubation (total 3 hours)
  arm group label: 20 extremely low birth weight infants
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 28 Weeks
  healthy volunteers: No
  last name: Wissam Shalish, MD, PhD
  role: Principal Investigator
  affiliation: McGill University Health Center/Montreal Children's hospital
  last name: Wissam Shalish, MD, PhD
  phone: +1(514) 4124452
  phone ext: 22341
  email: wissam.shalish@mcgill.ca
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  facility: 
  contact: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
  investigator full name: Wissam Shalish
  investigator title: Assistant Professor of Pediatrics, McGill University Neonatologist, Montreal Children's Hospital
  mesh term: Birth Weight
  sharing ipd: No