<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/NCT02232009</url>
  </required_header>
  <id_info>
    <org_study_id>114-2013-GES-0011</org_study_id>
    <nct_id>NCT02232009</nct_id>
  </id_info>
  <brief_title>Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit</brief_title>
  <acronym>Firefly</acronym>
  <official_title>Development of MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GE Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wellcome Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>GE Healthcare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for&#xD;
      imaging viable neonate and infant populations. This MR system has a smaller size and design&#xD;
      features that may make it more feasible to locate the system in close proximity to care areas&#xD;
      for neonates (birth - 1 month) and infants (less than 1 month to two years), such as clinical&#xD;
      neonatal intensive care units (NICUs) and other infant and neonatal care departments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for&#xD;
      imaging viable neonate and infant populations. This MR system has a smaller size and design&#xD;
      features that may make it more feasible to locate the system in close proximity to care areas&#xD;
      for neonates (birth - 1 month) and infants (&gt;1 month to two years), such as clinical neonatal&#xD;
      intensive care units (NICUs) and other infant and neonatal care departments.&#xD;
&#xD;
      This is a two-phase prospective clinical study evaluating the performance and safety of the&#xD;
      investigational MRI device for neonates and infants, including:&#xD;
&#xD;
        -  Phase 1 - Initial feasibility assessment and optimization study (Phase 1) which may&#xD;
           include hardware and software modifications. These studies are guided by a series of MR&#xD;
           scanning procedures defined in sequential Sponsor-provided MR Procedure Documents&#xD;
&#xD;
        -  Phase 2 - Controlled image and data collection study based on Phase 1 results, in which&#xD;
           optimized scan procedure(s) according to MR Procedure Document(s) will be provided at&#xD;
           the start of Phase 2 scanning and a fixed hardware and integrated software configuration&#xD;
           will be applied for all subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow/low enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">May 7, 2015</start_date>
  <completion_date type="Actual">November 30, 2016</completion_date>
  <primary_completion_date type="Actual">November 30, 2016</primary_completion_date>
  <phase>N/A</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Summary Rates of Adverse Events</measure>
    <time_frame>1 Day</time_frame>
    <description>Safety will be assessed based on the number of Adverse Events.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Image Diagnostic Quality</measure>
    <time_frame>1 Day</time_frame>
    <description>Number of subject whose images were rated as Evaluable</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MRI Scan Time</measure>
    <time_frame>1 Day</time_frame>
    <description>Duration of MRI scan time for each subject</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Experience With Neonatal MR Scanner Device Summary</measure>
    <time_frame>1 day</time_frame>
    <description>User survey results on a scale from 1 to 5, where 1 = strongly disagree and 5 = strongly agree.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Image Quality</measure>
    <time_frame>1 day</time_frame>
    <description>Scores range from 1-Very Poor image quality to 5-Excellent image quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Change in Temperature</measure>
    <time_frame>1 Day</time_frame>
    <description>Change in temperature (Celsius) per subject.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Image Evaluation</condition>
  <arm_group>
    <arm_group_label>3.0 T Neonatal Scanner</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3.0 T Neonatal MRI Scanner</intervention_name>
    <description>Eligible subjects will undergo neonatal MRI scanning procedures.</description>
    <arm_group_label>3.0 T Neonatal Scanner</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects will be included that are:&#xD;
&#xD;
          1. Currently admitted for treatment or observation at the investigational site at the&#xD;
             time of enrollment;&#xD;
&#xD;
          2. In the weight range less than 5.0 kg (&lt;5.0 kg ) and more than 0.5 kg (&gt;0.5 kg );&#xD;
&#xD;
          3. Viable neonates (birth to 1 month of age) or infants (&gt;1 month to two years of age);&#xD;
&#xD;
          4. Able to safely undergo an MRI scan, as determined by the site's co-investigator&#xD;
             neonatologist or medically qualified delegate;&#xD;
&#xD;
          5. Have parent(s), guardian(s), or legally authorized representative(s) willing and able&#xD;
             to provide written informed consent for the subject's participation;&#xD;
&#xD;
          6. Are of appropriate size and shape to fit into the bore of the magnet, inclusive of all&#xD;
             monitoring equipment, if any, necessary for the subject's routine clinical care:&#xD;
&#xD;
               1. Maximum width (shoulder-to-shoulder measurement) less than eighteen (18 cm).&#xD;
&#xD;
               2. Maximum length (head-to-foot measurement) less than sixty (60) cm. -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects will be excluded that:&#xD;
&#xD;
               1. Have parent(s), guardian(s), or legally authorized representative(s) that require&#xD;
                  that they accompany the subject into the MR environment that have&#xD;
                  contraindications to the MR environment or would otherwise be put at undue risk&#xD;
                  or discomfort, as determined by the investigators;&#xD;
&#xD;
               2. Require any non-removable medical devices that are not compatible with MR&#xD;
                  scanning (labeled as MR Unsafe, MR condition for which the scanning conditions&#xD;
                  are not met, or no MR safety labeling) that may pose hazards in the MR scanning&#xD;
                  or MR environment, in the opinion of the neonatologist co-investigator or&#xD;
                  medically qualified delegate;&#xD;
&#xD;
               3. Have other contraindications or could otherwise be expected to experience&#xD;
                  detrimental effects to safety, well-being, or medical care, as determined by the&#xD;
                  neonatologist co-investigator;&#xD;
&#xD;
               4. Require any scheduled standard of care procedures that are expected to be&#xD;
                  adversely impacted by participation in this study, in the opinion of the&#xD;
                  principal investigator, neonatologist co-investigator, or medically qualified&#xD;
                  delegate; and&#xD;
&#xD;
               5. Have been previously enrolled AND undergone any study procedures under the&#xD;
                  current study protocol (i.e. the same subject cannot undergo study procedures,&#xD;
                  including swaddling and/or MR scanning, more than once).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <results_first_submitted>December 3, 2018</results_first_submitted>
  <results_first_submitted_qc>January 10, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 30, 2019</results_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neonate</keyword>
  <keyword>Infant</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>3.0 T Neonatal Scanner</title>
          <description>All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.&#xD;
3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>3.0 T Neonatal Scanner</title>
          <description>All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.&#xD;
3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Summary Rates of Adverse Events</title>
        <description>Safety will be assessed based on the number of Adverse Events.</description>
        <time_frame>1 Day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>3.0 T Neonatal Scanner</title>
            <description>All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.&#xD;
3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures.</description>
          </group>
        </group_list>
        <measure>
          <title>Summary Rates of Adverse Events</title>
          <description>Safety will be assessed based on the number of Adverse Events.</description>
          <units>number of occurrences</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Image Diagnostic Quality</title>
        <description>Number of subject whose images were rated as Evaluable</description>
        <time_frame>1 Day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>3.0 T Neonatal Scanner</title>
            <description>All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.&#xD;
3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures.</description>
          </group>
        </group_list>
        <measure>
          <title>Image Diagnostic Quality</title>
          <description>Number of subject whose images were rated as Evaluable</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MRI Scan Time</title>
        <description>Duration of MRI scan time for each subject</description>
        <time_frame>1 Day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>3.0 T Neonatal Scanner</title>
            <description>All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.&#xD;
3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures.</description>
          </group>
        </group_list>
        <measure>
          <title>MRI Scan Time</title>
          <description>Duration of MRI scan time for each subject</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57" spread="6.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Experience With Neonatal MR Scanner Device Summary</title>
        <description>User survey results on a scale from 1 to 5, where 1 = strongly disagree and 5 = strongly agree.</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>3.0 T Neonatal Scanner</title>
            <description>All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.&#xD;
3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Experience With Neonatal MR Scanner Device Summary</title>
          <description>User survey results on a scale from 1 to 5, where 1 = strongly disagree and 5 = strongly agree.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Like to use frequently</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.22" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unnecessarily complex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.11" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Easy to Use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.56" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Would need tech support to use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Functions are well integrated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.89" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Too much inconsistency</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.78" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Most people would learn quickly</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cumbersome to use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Felt confident using</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Needed to learn a lot before using</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.22" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>System meets patients needs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.56" lower_limit="3" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Would recommend to others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.44" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Image Quality</title>
        <description>Scores range from 1-Very Poor image quality to 5-Excellent image quality.</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>3.0 T Neonatal Scanner</title>
            <description>All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.&#xD;
3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Image Quality</title>
          <description>Scores range from 1-Very Poor image quality to 5-Excellent image quality.</description>
          <units>Frequency of ratings</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1-Very Poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2-Poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5-Excellent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Change in Temperature</title>
        <description>Change in temperature (Celsius) per subject.</description>
        <time_frame>1 Day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>3.0 T Neonatal Scanner</title>
            <description>All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.&#xD;
3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Change in Temperature</title>
          <description>Change in temperature (Celsius) per subject.</description>
          <units>Degrees Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>3.0 T Neonatal Scanner</title>
          <description>All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.&#xD;
3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Redness behind ears</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Yvonne Celestial</name_or_title>
      <organization>GE Healthcare</organization>
      <phone>+33 130709133</phone>
      <email>MarieYvonne.CELESTIAL@ge.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02232009
org study id: 114-2013-GES-0011
nct id: NCT02232009
lead sponsor: 
collaborator: 
has dmc: No
This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for
      imaging viable neonate and infant populations. This MR system has a smaller size and design
      features that may make it more feasible to locate the system in close proximity to care areas
      for neonates (birth - 1 month) and infants (less than 1 month to two years), such as clinical
      neonatal intensive care units (NICUs) and other infant and neonatal care departments.
This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for
      imaging viable neonate and infant populations. This MR system has a smaller size and design
      features that may make it more feasible to locate the system in close proximity to care areas
      for neonates (birth - 1 month) and infants (>1 month to two years), such as clinical neonatal
      intensive care units (NICUs) and other infant and neonatal care departments.

      This is a two-phase prospective clinical study evaluating the performance and safety of the
      investigational MRI device for neonates and infants, including:

        -  Phase 1 - Initial feasibility assessment and optimization study (Phase 1) which may
           include hardware and software modifications. These studies are guided by a series of MR
           scanning procedures defined in sequential Sponsor-provided MR Procedure Documents

        -  Phase 2 - Controlled image and data collection study based on Phase 1 results, in which
           optimized scan procedure(s) according to MR Procedure Document(s) will be provided at
           the start of Phase 2 scanning and a fixed hardware and integrated software configuration
           will be applied for all subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Summary Rates of Adverse Events
time frame: 1 Day
description: Safety will be assessed based on the number of Adverse Events.
measure: Image Diagnostic Quality
time frame: 1 Day
description: Number of subject whose images were rated as Evaluable
measure: MRI Scan Time
time frame: 1 Day
description: Duration of MRI scan time for each subject
measure: Overall Experience With Neonatal MR Scanner Device Summary
time frame: 1 day
description: User survey results on a scale from 1 to 5, where 1 = strongly disagree and 5 = strongly agree.
measure: Overall Image Quality
time frame: 1 day
description: Scores range from 1-Very Poor image quality to 5-Excellent image quality.
measure: Subject Change in Temperature
time frame: 1 Day
description: Change in temperature (Celsius) per subject.
arm group label: 3.0 T Neonatal Scanner
arm group type: Other
description: All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner.
intervention type: Device
intervention name: 3.0 T Neonatal MRI Scanner
description: Eligible subjects will undergo neonatal MRI scanning procedures.
arm group label: 3.0 T Neonatal Scanner
criteria: 
gender: All
minimum age: N/A
maximum age: 2 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 