<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/NCT03245723</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0238</org_study_id>
    <secondary_id>UL1TR000427</secondary_id>
    <secondary_id>A534285</secondary_id>
    <secondary_id>SMPH/MEDICINE/MEDICINE*P</secondary_id>
    <secondary_id>Protocol Version 4/23/2019</secondary_id>
    <nct_id>NCT03245723</nct_id>
  </id_info>
  <brief_title>Cardiac Function and Metabolism in Young Adults Born Premature (PET-MRI)</brief_title>
  <acronym>PET-MRI</acronym>
  <official_title>Cardiac Function and Metabolism in Young Adults Born Premature</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Heart Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</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>
      The purpose of this research is to determine the effect of premature birth on later heart&#xD;
      function and metabolism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine the effects of premature birth on cardiac function,&#xD;
      cardiac metabolism, and oxidative stress in a cohort of young adults born prematurely using&#xD;
      cardiac positron emission tomography/magnetic resonance imaging and mitochondrial respiration&#xD;
      studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Actual">February 26, 2020</completion_date>
  <primary_completion_date type="Actual">February 26, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Young adults born premature (some of them are registered on the National Lung Project) and Healthy Controls will undergo pulmonary function testing, cardiac positron emission tomography, and cardiac magnetic resonance imaging.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac Glucose Uptake During Normoxic Rest (µg/Min)</measure>
    <time_frame>Visit 1 (1 day)</time_frame>
    <description>Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Glucose Uptake From Normoxia to Hypoxia (µg/Min)</measure>
    <time_frame>Visit 1 (1 day)</time_frame>
    <description>Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Infant,Premature</condition>
  <arm_group>
    <arm_group_label>Preterm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants born premature either registered on the National Lung Project (currently in their late twenties) or not registered on the National Lung Project Cohort (current age ranges 18-35 years).&#xD;
All the participants in this group will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Term - Healthy Controls</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Healthy individuals that were not born premature. Individuals are ages 18-35. Subjects will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pulmonary Function Testing</intervention_name>
    <description>Subjects will undergo Spirometry and Plethysmography</description>
    <arm_group_label>Preterm</arm_group_label>
    <arm_group_label>Term - Healthy Controls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electrocardiogram</intervention_name>
    <description>Subjects will undergo an electrocardiogram to ensure sinus rhythm</description>
    <arm_group_label>Preterm</arm_group_label>
    <arm_group_label>Term - Healthy Controls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Positron Emission Tomography</intervention_name>
    <description>Subjects will undergo positron emission tomography to detect images of the heart</description>
    <arm_group_label>Preterm</arm_group_label>
    <arm_group_label>Term - Healthy Controls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Magnetic Resonance Imaging</intervention_name>
    <description>Subjects will undergo positron magnetic resonance imaging to detect images of the heart</description>
    <arm_group_label>Preterm</arm_group_label>
    <arm_group_label>Term - Healthy Controls</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  National Lung Project Cohort only- birth weight &lt;1500g and a gestational age &lt;36 weeks&#xD;
&#xD;
          -  Adults born preterm (Non-National Lung Project) only- gestational age ≤32 weeks OR&#xD;
             birth weight ≤ 3lbs 5oz&#xD;
&#xD;
          -  Healthy Controls only- No personal history of known cardiovascular or pulmonary&#xD;
             disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Metabolic Disorders that would affect Fludeoxyglucose uptake&#xD;
&#xD;
          -  Contraindications to positron emission tomography and/or magnetic resonance imaging&#xD;
&#xD;
          -  Pregnancy, if a female of child-bearing potential&#xD;
&#xD;
          -  A personal history of Type I or Type II diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kara N Goss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Wisconsin School of Medicine and Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UW Madison</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <results_first_submitted>January 14, 2021</results_first_submitted>
  <results_first_submitted_qc>February 2, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 4, 2021</results_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>premature adults</keyword>
  <keyword>premature</keyword>
  <keyword>premature lung function</keyword>
  <keyword>premature cardiac function</keyword>
  <keyword>MRI</keyword>
  <keyword>PET</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 23, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03245723/Prot_SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Out of 52 enrolled participants, no data was collected for 2 participants due to COVID. 50 participants were allocated to intervention.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Preterm</title>
          <description>Participants born premature either registered on the National Lung Project (currently in their late twenties) or not registered on the National Lung Project Cohort (current age ranges 18-35 years).&#xD;
All the participants in this group will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.&#xD;
Pulmonary Function Testing: Subjects will undergo Spirometry and Plethysmography&#xD;
Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm&#xD;
Positron Emission Tomography: Subjects will undergo positron emission tomography to detect images of the heart&#xD;
Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart</description>
        </group>
        <group group_id="P2">
          <title>Term - Healthy Controls</title>
          <description>Healthy individuals that were not born premature. Individuals are ages 18-35. Subjects will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.&#xD;
Pulmonary Function Testing: Subjects will undergo Spirometry and Plethysmography&#xD;
Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm&#xD;
Positron Emission Tomography: Subjects will undergo positron emission tomography to detect images of the heart&#xD;
Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Bigeminy precluding hypoxia exposure</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Claustrophobia from wearing the mask</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Having to abruptly stop the scan to use the restroom</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Image acquisition/reconstruction failure</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Preterm</title>
          <description>Participants born premature either registered on the National Lung Project (currently in their late twenties) or not registered on the National Lung Project Cohort (current age ranges 18-35 years).&#xD;
All the participants in this group will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.&#xD;
Pulmonary Function Testing: Subjects will undergo Spirometry and Plethysmography&#xD;
Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm&#xD;
Positron Emission Tomography: Subjects will undergo positron emission tomography to detect images of the heart&#xD;
Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart</description>
        </group>
        <group group_id="B2">
          <title>Term - Healthy Controls</title>
          <description>Healthy individuals that were not born premature. Individuals are ages 18-35. Subjects will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.&#xD;
Pulmonary Function Testing: Subjects will undergo Spirometry and Plethysmography&#xD;
Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm&#xD;
Positron Emission Tomography: Subjects will undergo positron emission tomography to detect images of the heart&#xD;
Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="32"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Current age of participants</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.1" spread="4.2"/>
                    <measurement group_id="B2" value="25.4" spread="4.0"/>
                    <measurement group_id="B3" value="25.75" spread="4.1"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gestational age (Neonatal Characteristics)</title>
          <description>Neonatal characteristics-gestational age of participants at the time of birth</description>
          <units>Weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.2" spread="2.5"/>
                    <measurement group_id="B2" value="39.8" spread="1.0"/>
                    <measurement group_id="B3" value="34.5" spread="1.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Birth weight (Neonatal Characteristics)</title>
          <units>Grams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1225" spread="397"/>
                    <measurement group_id="B2" value="3397" spread="572"/>
                    <measurement group_id="B3" value="2311" spread="484.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cardiac Glucose Uptake During Normoxic Rest (µg/Min)</title>
        <description>Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.</description>
        <time_frame>Visit 1 (1 day)</time_frame>
        <population>Data was not collected for 4 preterm participants due to following reasons:&#xD;
bigeminy precluding hypoxia exposure (N=1),&#xD;
claustrophobia from wearing the mask (N=1),&#xD;
having to abruptly stop the scan to use the restroom (N=2).</population>
        <group_list>
          <group group_id="O1">
            <title>Preterm</title>
            <description>Participants born premature either registered on the National Lung Project (currently in their late twenties) or not registered on the National Lung Project Cohort (current age ranges 18-35 years).&#xD;
All the participants in this group will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.&#xD;
Pulmonary Function Testing: Subjects will undergo Spirometry and Plethysmography&#xD;
Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm&#xD;
Positron Emission Tomography: Subjects will undergo positron emission tomography to detect images of the heart&#xD;
Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart</description>
          </group>
          <group group_id="O2">
            <title>Term - Healthy Controls</title>
            <description>Healthy individuals that were not born premature. Individuals are ages 18-35. Subjects will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.&#xD;
Pulmonary Function Testing: Subjects will undergo Spirometry and Plethysmography&#xD;
Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm&#xD;
Positron Emission Tomography: Subjects will undergo positron emission tomography to detect images of the heart&#xD;
Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart</description>
          </group>
        </group_list>
        <measure>
          <title>Cardiac Glucose Uptake During Normoxic Rest (µg/Min)</title>
          <description>Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.</description>
          <population>Data was not collected for 4 preterm participants due to following reasons:&#xD;
bigeminy precluding hypoxia exposure (N=1),&#xD;
claustrophobia from wearing the mask (N=1),&#xD;
having to abruptly stop the scan to use the restroom (N=2).</population>
          <units>µg/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.689" spread="0.546"/>
                    <measurement group_id="O2" value="0.540" spread="0.454"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Descriptive statistics</non_inferiority_desc>
            <p_value>0.38</p_value>
            <method>Wilcoxon Rank Sum test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Glucose Uptake From Normoxia to Hypoxia (µg/Min)</title>
        <description>Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.</description>
        <time_frame>Visit 1 (1 day)</time_frame>
        <population>5 preterm and 1 term participants did nor receive the allocated intervention due to :&#xD;
bigeminy precluding hypoxia exposure (N=1 preterm),&#xD;
claustrophobia from wearing the mask (N=1 preterm),&#xD;
having to abruptly stop the scan to use the restroom (N=2 preterm).&#xD;
image acquisition/reconstruction failure (n = 2,1 preterm and 1 term)</population>
        <group_list>
          <group group_id="O1">
            <title>Preterm</title>
            <description>Participants born premature either registered on the National Lung Project (currently in their late twenties) or not registered on the National Lung Project Cohort (current age ranges 18-35 years).&#xD;
All the participants in this group will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.&#xD;
Pulmonary Function Testing: Subjects will undergo Spirometry and Plethysmography&#xD;
Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm&#xD;
Positron Emission Tomography: Subjects will undergo positron emission tomography to detect images of the heart&#xD;
Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart</description>
          </group>
          <group group_id="O2">
            <title>Term - Healthy Controls</title>
            <description>Healthy individuals that were not born premature. Individuals are ages 18-35. Subjects will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.&#xD;
Pulmonary Function Testing: Subjects will undergo Spirometry and Plethysmography&#xD;
Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm&#xD;
Positron Emission Tomography: Subjects will undergo positron emission tomography to detect images of the heart&#xD;
Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Glucose Uptake From Normoxia to Hypoxia (µg/Min)</title>
          <description>Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.</description>
          <population>5 preterm and 1 term participants did nor receive the allocated intervention due to :&#xD;
bigeminy precluding hypoxia exposure (N=1 preterm),&#xD;
claustrophobia from wearing the mask (N=1 preterm),&#xD;
having to abruptly stop the scan to use the restroom (N=2 preterm).&#xD;
image acquisition/reconstruction failure (n = 2,1 preterm and 1 term)</population>
          <units>µg/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.264" spread="0.588"/>
                    <measurement group_id="O2" value="-0.003" spread="0.390"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Descriptive statistics</non_inferiority_desc>
            <p_value>0.12</p_value>
            <method>Wilcoxon Rank Sum test</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 day</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Preterm</title>
          <description>Participants born premature either registered on the National Lung Project (currently in their late twenties) or not registered on the National Lung Project Cohort (current age ranges 18-35 years).&#xD;
All the participants in this group will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.&#xD;
Pulmonary Function Testing: Subjects will undergo Spirometry and Plethysmography&#xD;
Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm&#xD;
Positron Emission Tomography: Subjects will undergo positron emission tomography to detect images of the heart&#xD;
Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart</description>
        </group>
        <group group_id="E2">
          <title>Term - Healthy Controls</title>
          <description>Healthy individuals that were not born premature. Individuals are ages 18-35. Subjects will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.&#xD;
Pulmonary Function Testing: Subjects will undergo Spirometry and Plethysmography&#xD;
Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm&#xD;
Positron Emission Tomography: Subjects will undergo positron emission tomography to detect images of the heart&#xD;
Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart</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="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr. Kara Goss</name_or_title>
      <organization>UT Southwestern Medical Center, Dallas, Texas</organization>
      <phone>214-648-6868</phone>
      <email>kara.goss@utsouthwestern.edu</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/NCT03245723
org study id: 2017-0238
secondary id: UL1TR000427
secondary id: A534285
secondary id: SMPH/MEDICINE/MEDICINE*P
secondary id: Protocol Version 4/23/2019
nct id: NCT03245723
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research is to determine the effect of premature birth on later heart
      function and metabolism.
The purpose of this study is to determine the effects of premature birth on cardiac function,
      cardiac metabolism, and oxidative stress in a cohort of young adults born prematurely using
      cardiac positron emission tomography/magnetic resonance imaging and mitochondrial respiration
      studies.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Young adults born premature (some of them are registered on the National Lung Project) and Healthy Controls will undergo pulmonary function testing, cardiac positron emission tomography, and cardiac magnetic resonance imaging.
primary purpose: Other
masking: None (Open Label)
measure: Cardiac Glucose Uptake During Normoxic Rest (µg/Min)
time frame: Visit 1 (1 day)
description: Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.
measure: Change in Glucose Uptake From Normoxia to Hypoxia (µg/Min)
time frame: Visit 1 (1 day)
description: Cardiac glucose uptake will be measured via 18F-fluorodeoxyglucose (FDG) PET-MRI.
arm group label: Preterm
arm group type: Active Comparator
description: Participants born premature either registered on the National Lung Project (currently in their late twenties) or not registered on the National Lung Project Cohort (current age ranges 18-35 years).
All the participants in this group will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.
arm group label: Term - Healthy Controls
arm group type: Placebo Comparator
description: Healthy individuals that were not born premature. Individuals are ages 18-35. Subjects will undergo Pulmonary Function Testing, Electrocardiogram, Positron Emission Tomography, and Magnetic Resonance Imaging.
intervention type: Procedure
intervention name: Pulmonary Function Testing
description: Subjects will undergo Spirometry and Plethysmography
arm group label: Preterm
arm group label: Term - Healthy Controls
intervention type: Procedure
intervention name: Electrocardiogram
description: Subjects will undergo an electrocardiogram to ensure sinus rhythm
arm group label: Preterm
arm group label: Term - Healthy Controls
intervention type: Procedure
intervention name: Positron Emission Tomography
description: Subjects will undergo positron emission tomography to detect images of the heart
arm group label: Preterm
arm group label: Term - Healthy Controls
intervention type: Procedure
intervention name: Magnetic Resonance Imaging
description: Subjects will undergo positron magnetic resonance imaging to detect images of the heart
arm group label: Preterm
arm group label: Term - Healthy Controls
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kara N Goss, MD
role: Principal Investigator
affiliation: The University of Wisconsin School of Medicine and Public Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Premature Birth
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 