<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/NCT02260271</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201501109</org_study_id>
    <nct_id>NCT02260271</nct_id>
  </id_info>
  <brief_title>Florida Neonatal Neurologic Network</brief_title>
  <acronym>FN3</acronym>
  <official_title>Florida Neonatal Neurologic Network</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Create a database with selected medical information on infants born with hypoxic-ischemic&#xD;
      encephalopathy (HIE). In addition, the following samples will be collected in a&#xD;
      bio-repository for future studies: blood, urine, and buccal samples.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to create a detailed medical and sample database of infants born&#xD;
      with HIE. Both the medical information and the samples are de-identified. Any future studies&#xD;
      performed with the data and samples will receive Institutional Review Board (IRB) approval.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of blood-based biomarkers of neonatal Hypoxic Ischemic Encephalopathy (HIE)</measure>
    <time_frame>2 years</time_frame>
    <description>Measure HIE biomarker levels in blood samples obtained in infants born with HIE.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Hypoxic-Ischemic Encephalopathy</condition>
  <arm_group>
    <arm_group_label>Database Entry/Biospecimen Collection</arm_group_label>
    <description>Medical information of infants born with HIE entered into RedCap database. In addition, Blood, urine, buccal samples will be collected.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Database Entry/Biospecimen Collection</intervention_name>
    <description>blood, urine, buccal samples and medical data collected</description>
    <arm_group_label>Database Entry/Biospecimen Collection</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood, urine and buccal samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Infants diagnosed with hypoxic-ischemic encepholopathy (HIE) at birth&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational Age greater than or equal to 35 weeks gestation&#xD;
&#xD;
          -  Birth weight greater than or equal to 1.8 kg&#xD;
&#xD;
          -  Less than or equal to 6 hours since insult occurred&#xD;
&#xD;
          -  Severe hypoxic-ischemic encepholopathy (HIE)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of lethal chromosomal abnormalities&#xD;
&#xD;
          -  Severe IUGR&#xD;
&#xD;
          -  Significant intracranial hemorrhage with a large intracranial hemorrhage (Grade III or&#xD;
             intraparenchymal echodensity (Grade IV))&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>3 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael D Weiss, 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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>May 18, 2023</last_update_submitted>
  <last_update_submitted_qc>May 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Diseases</mesh_term>
    <mesh_term>Brain Ischemia</mesh_term>
    <mesh_term>Hypoxia-Ischemia, Brain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT02260271
org study id: IRB201501109
nct id: NCT02260271
lead sponsor: 
has dmc: No
Create a database with selected medical information on infants born with hypoxic-ischemic
      encephalopathy (HIE). In addition, the following samples will be collected in a
      bio-repository for future studies: blood, urine, and buccal samples.
The purpose of this study is to create a detailed medical and sample database of infants born
      with HIE. Both the medical information and the samples are de-identified. Any future studies
      performed with the data and samples will receive Institutional Review Board (IRB) approval.
observational model: Case-Only
time perspective: Retrospective
measure: Measurement of blood-based biomarkers of neonatal Hypoxic Ischemic Encephalopathy (HIE)
time frame: 2 years
description: Measure HIE biomarker levels in blood samples obtained in infants born with HIE.
arm group label: Database Entry/Biospecimen Collection
description: Medical information of infants born with HIE entered into RedCap database. In addition, Blood, urine, buccal samples will be collected.
intervention type: Other
intervention name: Database Entry/Biospecimen Collection
description: blood, urine, buccal samples and medical data collected
arm group label: Database Entry/Biospecimen Collection
blood, urine and buccal samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 3 Weeks
healthy volunteers: No
last name: Michael D Weiss, MD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Diseases
mesh term: Brain Ischemia
mesh term: Hypoxia-Ischemia, Brain
sharing ipd: Undecided