<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/NCT02210026</url>
  </required_header>
  <id_info>
    <org_study_id>Seattle-PAP 001</org_study_id>
    <nct_id>NCT02210026</nct_id>
  </id_info>
  <brief_title>Seattle-PAP Bubble Nasal CPAP and Work of Breathing</brief_title>
  <acronym>Seattle-PAP</acronym>
  <official_title>A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seattle Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators propose to test the hypothesis that Seattle bubble nasal continuous&#xD;
      positive airway pressure (Seattle-PAP) supports respiratory physiology in very low birth&#xD;
      weight (VLBW) infants more effectively than standard bubble nasal continuous positive airway&#xD;
      pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary outcome variable is work of breathing (WOB) over a two hour period, estimated&#xD;
      from pressure-rate products, which are assessed with 6 Fr (2 mm) catheters placed in the&#xD;
      distal esophagus for monitoring esophageal pressures (Pes), thereby estimating changes in&#xD;
      pleural pressures during breath cycles. The following endpoints would also be assessed:&#xD;
      Oxygen saturations and Fraction of Inspired Oxygen (FiO2) needed to keep saturations in&#xD;
      acceptable ranges, Heart Rates (HR), transcutaneous carbon dioxide (TcPCO2), and respiratory&#xD;
      rates throughout the 6 hour study period.&#xD;
&#xD;
      Objective determination of when an infant requires more or less respiratory support is&#xD;
      difficult, but measurements of pressure-rate products as estimates of work of breathing,&#xD;
      using esophageal catheters, can estimate an infant's respiratory effort. However, objective,&#xD;
      simple-to-use, low cost, and non-invasive methods and tools to determine an infant's&#xD;
      respiratory effort do not exist currently.&#xD;
&#xD;
      This study also is designed to test the hypothesis that infants' chest and abdominal&#xD;
      movements can be assessed quantitatively from video images in ways that can be correlated&#xD;
      with intrathoracic pressures, as measured with esophageal catheters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>Phase 1</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Work of Breathing</measure>
    <time_frame>Six hours</time_frame>
    <description>The primary outcome variable is work of breathing (WOB) over three two hour periods, estimated from pressure-rate products, which are assessed with 6 Fr (2 mm) catheters placed in the distal esophagus for monitoring esophageal pressures (Pes), thereby estimating changes in pleural pressures during breath cycles.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Video Recordings of Chest and Abdomen Movements during Breathing</measure>
    <time_frame>Six hours</time_frame>
    <description>This study also is designed to test the hypothesis that infants' chest and abdominal movements can be assessed quantitatively from video images in ways that can be correlated with intrathoracic pressures, as measured with esophageal catheters.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>FiO2</measure>
    <time_frame>Six hours</time_frame>
    <description>Fraction of Inspired Oxygen (FiO2) needed to keep oxygen saturations in acceptable ranges will be assessed throughout the 6 hour study period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Heart Rates</measure>
    <time_frame>Six hours</time_frame>
    <description>Heart rates will be assessed during the study period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Transcutaneous Carbon Dioxide Levels</measure>
    <time_frame>Six hours</time_frame>
    <description>Transcutaneous carbon dioxide (TcPCO2) levels will be assessed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Respiratory Rates</measure>
    <time_frame>Six hours</time_frame>
    <description>Respiratory rates will be assessed.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Respiratory Distress Syndrome In Premature Infants</condition>
  <condition>Bronchopulmonary Dysplasia</condition>
  <condition>Newborn Primary Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants will be assessed on standard bubble nasal CPAP, then on Seattle-PAP bubble nasal CPAP, then again on standard bubble nasal CPAP.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Seattle-PAP</intervention_name>
    <description>We propose to test the hypothesis that by introduction of variation in airway pressure Seattle bubble nasal continuous positive airway pressure (Seattle-PAP) reduces work of breathing in very low birth weight infants more effectively than standard bubble nasal continuous positive airway pressure.</description>
    <arm_group_label>Experimental</arm_group_label>
    <other_name>Sea-PAP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  infant born less than 32 weeks gestation&#xD;
&#xD;
          -  admitted to texas pavilion for women&#xD;
&#xD;
          -  between 6 and 72 hours post delivery&#xD;
&#xD;
          -  stable on standard bubble nasal CPAP&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  major congenital anomalies or suspected chromosomal anomalies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Hours</minimum_age>
    <maximum_age>72 Hours</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles V Smith, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Seattle Children's</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephen E Welty, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>April 12, 2016</last_update_submitted>
  <last_update_submitted_qc>April 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seattle Children's Hospital</investigator_affiliation>
    <investigator_full_name>Charles Smith</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>bubble nasal continuous positive airway pressure (Bn-CPAP)</keyword>
  <keyword>work of breathing</keyword>
  <keyword>pressure-rate products</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Bronchopulmonary Dysplasia</mesh_term>
    <mesh_term>Sleep Apnea, Central</mesh_term>
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>May 26, 2017</submitted>
    <returned>June 22, 2017</returned>
  </pending_results>
  <!-- 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/NCT02210026
org study id: Seattle-PAP 001
nct id: NCT02210026
lead sponsor: 
collaborator: 
has dmc: Yes
The investigators propose to test the hypothesis that Seattle bubble nasal continuous
      positive airway pressure (Seattle-PAP) supports respiratory physiology in very low birth
      weight (VLBW) infants more effectively than standard bubble nasal continuous positive airway
      pressure.
The primary outcome variable is work of breathing (WOB) over a two hour period, estimated
      from pressure-rate products, which are assessed with 6 Fr (2 mm) catheters placed in the
      distal esophagus for monitoring esophageal pressures (Pes), thereby estimating changes in
      pleural pressures during breath cycles. The following endpoints would also be assessed:
      Oxygen saturations and Fraction of Inspired Oxygen (FiO2) needed to keep saturations in
      acceptable ranges, Heart Rates (HR), transcutaneous carbon dioxide (TcPCO2), and respiratory
      rates throughout the 6 hour study period.

      Objective determination of when an infant requires more or less respiratory support is
      difficult, but measurements of pressure-rate products as estimates of work of breathing,
      using esophageal catheters, can estimate an infant's respiratory effort. However, objective,
      simple-to-use, low cost, and non-invasive methods and tools to determine an infant's
      respiratory effort do not exist currently.

      This study also is designed to test the hypothesis that infants' chest and abdominal
      movements can be assessed quantitatively from video images in ways that can be correlated
      with intrathoracic pressures, as measured with esophageal catheters.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Work of Breathing
time frame: Six hours
description: The primary outcome variable is work of breathing (WOB) over three two hour periods, estimated from pressure-rate products, which are assessed with 6 Fr (2 mm) catheters placed in the distal esophagus for monitoring esophageal pressures (Pes), thereby estimating changes in pleural pressures during breath cycles.
measure: Video Recordings of Chest and Abdomen Movements during Breathing
time frame: Six hours
description: This study also is designed to test the hypothesis that infants' chest and abdominal movements can be assessed quantitatively from video images in ways that can be correlated with intrathoracic pressures, as measured with esophageal catheters.
measure: FiO2
time frame: Six hours
description: Fraction of Inspired Oxygen (FiO2) needed to keep oxygen saturations in acceptable ranges will be assessed throughout the 6 hour study period.
measure: Heart Rates
time frame: Six hours
description: Heart rates will be assessed during the study period.
measure: Transcutaneous Carbon Dioxide Levels
time frame: Six hours
description: Transcutaneous carbon dioxide (TcPCO2) levels will be assessed.
measure: Respiratory Rates
time frame: Six hours
description: Respiratory rates will be assessed.
arm group label: Experimental
arm group type: Experimental
description: Infants will be assessed on standard bubble nasal CPAP, then on Seattle-PAP bubble nasal CPAP, then again on standard bubble nasal CPAP.
intervention type: Device
intervention name: Seattle-PAP
description: We propose to test the hypothesis that by introduction of variation in airway pressure Seattle bubble nasal continuous positive airway pressure (Seattle-PAP) reduces work of breathing in very low birth weight infants more effectively than standard bubble nasal continuous positive airway pressure.
arm group label: Experimental
other name: Sea-PAP
criteria: 
gender: All
minimum age: 6 Hours
maximum age: 72 Hours
healthy volunteers: No
last name: Charles V Smith, PhD
role: Study Director
affiliation: Seattle Children's
last name: Stephen E Welty, MD
role: Principal Investigator
affiliation: Baylor College of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Seattle Children's Hospital
investigator full name: Charles Smith
investigator title: Professor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Bronchopulmonary Dysplasia
mesh term: Sleep Apnea, Central
mesh term: Premature Birth
submitted: May 26, 2017
returned: June 22, 2017