<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/NCT03277768</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201601508</org_study_id>
    <nct_id>NCT03277768</nct_id>
  </id_info>
  <brief_title>Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.</brief_title>
  <official_title>Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</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 proposed research evaluates tissue oxygenation (StO2) as measured by resonance raman&#xD;
      spectroscopy (RRS) in premature infants with and without patent ductus arteriosus (PDA). This&#xD;
      is a prospective observational study of infants born at &lt; 30 weeks of gestation. The primary&#xD;
      aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected&#xD;
      by RRS is more significant in premature infants with PDA in comparison to infants without&#xD;
      PDA. The secondary aim of this study is to determine if the difference in pre- and&#xD;
      post-ductal StO2 as detected by RRS is more significant in infant who develop serious adverse&#xD;
      events.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2015</start_date>
  <completion_date type="Actual">August 23, 2018</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Differences and pre- and post-ductal RRS measurements of tissue oxygenation.</measure>
    <time_frame>Up to a maximum of 14 data collection times</time_frame>
    <description>Pre- and post-ductal tissues oxygenation as measured by RRS may be more significant in infants with PDA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Are differences in pre- and post-ductal StO2 as detected by RRS more significant in infants with serious adverse events.</measure>
    <time_frame>Up to a maximum of 14 data collection times</time_frame>
    <description>RRS measurements and the difference between pre- and post-ductal tissue oxygenation will be evaluated in infants with serious adverse events to determine if the measurements could have predicted the serious adverse event.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">55</enrollment>
  <condition>Premature Infant</condition>
  <condition>Patent Ductus Arteriosus</condition>
  <condition>Hemodynamic Instability</condition>
  <arm_group>
    <arm_group_label>Control Group -Patent Ductus Arteriosus Absent</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Group - Patent Ductus Arteriosus Present</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Resonance Raman Spectroscopy (RRS)</intervention_name>
    <description>Pre and post-ductal RRS measurements will be obtained daily for a maximum of 14 data collection times in infants with and without PDAs.</description>
    <arm_group_label>Control Group -Patent Ductus Arteriosus Absent</arm_group_label>
    <arm_group_label>Study Group - Patent Ductus Arteriosus Present</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Premature infants born &lt;30 weeks gestational age and admitted to the Boston Children's&#xD;
        Hospital neonatal intensive care unit (NICU), Brigham and Women's NICU, and the University&#xD;
        of Florida NICU.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants &lt; 30 weeks estimated gestational age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants with major congenital anomalies&#xD;
&#xD;
          -  Infants &gt;34 weeks post-menstrual age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>J Lauren Ruoss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>September 2019</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 6, 2019</last_update_submitted>
  <last_update_submitted_qc>September 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Premature infant</keyword>
  <keyword>Tissue Oxygenation</keyword>
  <keyword>Patent Ductus Arteriosus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Ductus Arteriosus, Patent</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The analysis of the data will be shared with other research. Individual patient data will not be shared.</ipd_description>
  </patient_data>
  <!-- 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/NCT03277768
org study id: IRB201601508
nct id: NCT03277768
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed research evaluates tissue oxygenation (StO2) as measured by resonance raman
      spectroscopy (RRS) in premature infants with and without patent ductus arteriosus (PDA). This
      is a prospective observational study of infants born at < 30 weeks of gestation. The primary
      aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected
      by RRS is more significant in premature infants with PDA in comparison to infants without
      PDA. The secondary aim of this study is to determine if the difference in pre- and
      post-ductal StO2 as detected by RRS is more significant in infant who develop serious adverse
      events.
observational model: Cohort
time perspective: Prospective
measure: Differences and pre- and post-ductal RRS measurements of tissue oxygenation.
time frame: Up to a maximum of 14 data collection times
description: Pre- and post-ductal tissues oxygenation as measured by RRS may be more significant in infants with PDA.
measure: Are differences in pre- and post-ductal StO2 as detected by RRS more significant in infants with serious adverse events.
time frame: Up to a maximum of 14 data collection times
description: RRS measurements and the difference between pre- and post-ductal tissue oxygenation will be evaluated in infants with serious adverse events to determine if the measurements could have predicted the serious adverse event.
arm group label: Control Group -Patent Ductus Arteriosus Absent
arm group label: Study Group - Patent Ductus Arteriosus Present
intervention type: Device
intervention name: Resonance Raman Spectroscopy (RRS)
description: Pre and post-ductal RRS measurements will be obtained daily for a maximum of 14 data collection times in infants with and without PDAs.
arm group label: Control Group -Patent Ductus Arteriosus Absent
arm group label: Study Group - Patent Ductus Arteriosus Present
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: J Lauren Ruoss, MD
role: Principal Investigator
affiliation: University of Florida
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Premature Birth
mesh term: Ductus Arteriosus, Patent
sharing ipd: No
ipd description: The analysis of the data will be shared with other research. Individual patient data will not be shared.