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/NCT05968586</url>
    </required_header>
    <id_info>
      <org_study_id>22600</org_study_id>
      <nct_id>NCT05968586</nct_id>
    </id_info>
    <brief_title>Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants</brief_title>
    <official_title>Effect of Body Position on Oxygenation, Ventilation, and Diaphragmatic Workload in Premature Infants on Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Milton S. Hershey Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Milton S. Hershey 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>
        This research study is being done to investigate the effect of changing an infant's body&#xD;
        position on how hard the baby works to breathe, the baby's oxygen level, the baby's carbon&#xD;
        dioxide level, the baby's lung volume, the baby's lung compliance (ability of the lung to&#xD;
        expand and fill with air), and how frequently the baby develops clinically significant events&#xD;
        such as apnea (baby stops breathing on his own), bradycardia (low heart rate), and&#xD;
        desaturation (low oxygen) events.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Peak electrical activity of the diaphragm (Edi peaks)</measure>
      <time_frame>From enrollment in study to end of study (a total of twelve hours)</time_frame>
      <description>Height of Edi signal in uV</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Minimum electrical activity of the diaphragm (Edi mins)</measure>
      <time_frame>From enrollment in study to end of study (a total of twelve hours)</time_frame>
      <description>Lowest of Edi signal in uV</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of apenic events</measure>
      <time_frame>From enrollment in study to end of study (a total of twelve hours)</time_frame>
      <description>Number of times where infant ceases to breath for &gt;5 seconds</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of bradycardia events</measure>
      <time_frame>From enrollment in study to end of study (a total of twelve hours)</time_frame>
      <description>Number of times where infant's heart rate drops &lt;100bpm sustained for &gt;5s</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of desaturation events</measure>
      <time_frame>From enrollment in study to end of study (a total of twelve hours)</time_frame>
      <description>Number of times where infant's oxygen saturation drops &lt;85% sustained for &gt;5s</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Neonatal Oxygen Desaturation</condition>
    <condition>Premature</condition>
    <condition>Ventilator Lung; Newborn</condition>
    <condition>Apnea of Prematurity</condition>
    <arm_group>
      <arm_group_label>Prone positioning</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Supine positioning</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Body positioning</intervention_name>
      <description>Body positioning of infants prone vs supine.</description>
      <arm_group_label>Prone positioning</arm_group_label>
      <arm_group_label>Supine positioning</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Viable infants born at ≤32 weeks of gestation on non-invasive NAVA.&#xD;
  &#xD;
            -  Infant must be stable on NAVA for at least 24 hours prior to the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Infants with congenital heart disease (CHD)&#xD;
  &#xD;
            -  Infants with persistent pulmonary hypertension (PPHN)&#xD;
  &#xD;
            -  Infants with contraindications to using NAVA (e.g. neuromuscular blockage or&#xD;
               paralysis, absent electrical signal from the diaphragm, esophageal tears or bleeding,&#xD;
               cardiac pacemakers) or infants in whom an NG/OG catheter cannot be placed.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Minute</minimum_age>
      <maximum_age>3 Months</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kristin Glass, MD</last_name>
      <role>Study Director</role>
      <affiliation>Penn State College of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nada Darwish, MD</last_name>
      <phone>717-531-8941</phone>
      <email>ndarwish@pennstatehealth.psu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mitchell Kresch, MD</last_name>
      <phone>717-531-8413</phone>
      <email>mkresch@pennstatehealth.psu.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Penn State Health Milton S Hershey Medical Center</name>
        <address>
          <city>Hershey</city>
          <state>Pennsylvania</state>
          <zip>17033</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Nada Darwish, MD</last_name>
        <phone>717-531-8941</phone>
        <email>ndarwish@pennstatehealth.psu.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
      <investigator_full_name>Nada Darwish</investigator_full_name>
      <investigator_title>Neonatal-Perinatal Medicine Fellow</investigator_title>
    </responsible_party>
    <keyword>apnea of prematurity</keyword>
    <keyword>NAVA</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bronchopulmonary Dysplasia</mesh_term>
      <mesh_term>Premature Birth</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/NCT05968586
  org study id: 22600
  nct id: NCT05968586
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This research study is being done to investigate the effect of changing an infant's body
        position on how hard the baby works to breathe, the baby's oxygen level, the baby's carbon
        dioxide level, the baby's lung volume, the baby's lung compliance (ability of the lung to
        expand and fill with air), and how frequently the baby develops clinically significant events
        such as apnea (baby stops breathing on his own), bradycardia (low heart rate), and
        desaturation (low oxygen) events.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Peak electrical activity of the diaphragm (Edi peaks)
  time frame: From enrollment in study to end of study (a total of twelve hours)
  description: Height of Edi signal in uV
  measure: Minimum electrical activity of the diaphragm (Edi mins)
  time frame: From enrollment in study to end of study (a total of twelve hours)
  description: Lowest of Edi signal in uV
  measure: Number of apenic events
  time frame: From enrollment in study to end of study (a total of twelve hours)
  description: Number of times where infant ceases to breath for >5 seconds
  measure: Number of bradycardia events
  time frame: From enrollment in study to end of study (a total of twelve hours)
  description: Number of times where infant's heart rate drops <100bpm sustained for >5s
  measure: Number of desaturation events
  time frame: From enrollment in study to end of study (a total of twelve hours)
  description: Number of times where infant's oxygen saturation drops <85% sustained for >5s
  arm group label: Prone positioning
  arm group type: Experimental
  arm group label: Supine positioning
  arm group type: Active Comparator
  intervention type: Other
  intervention name: Body positioning
  description: Body positioning of infants prone vs supine.
  arm group label: Prone positioning
  arm group label: Supine positioning
  criteria: 
  gender: All
  minimum age: 1 Minute
  maximum age: 3 Months
  healthy volunteers: No
  last name: Kristin Glass, MD
  role: Study Director
  affiliation: Penn State College of Medicine
  last name: Nada Darwish, MD
  phone: 717-531-8941
  email: ndarwish@pennstatehealth.psu.edu
  last name: Mitchell Kresch, MD
  phone: 717-531-8413
  email: mkresch@pennstatehealth.psu.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Milton S. Hershey Medical Center
  investigator full name: Nada Darwish
  investigator title: Neonatal-Perinatal Medicine Fellow
  mesh term: Bronchopulmonary Dysplasia
  mesh term: Premature Birth
  sharing ipd: No