<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/NCT02264808</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201400699</org_study_id>
    <nct_id>NCT02264808</nct_id>
  </id_info>
  <brief_title>Developmental Outcomes</brief_title>
  <official_title>Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (HIE).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Heart Association</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>
      Determine whether the concentrations of UCH-L1 and GFAP measured in umbilical cord blood and&#xD;
      in blood 0-6 hours postnatal accurately predict the extent of neurodevelopmental deficits&#xD;
      and/or death at 18-20 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children born with Hypoxic Ischemic Encephalopathy (HIE) and already enrolled in IRB&#xD;
      #504-2011 will be seen for a developmental follow-up at 18-20 months of age. The&#xD;
      developmental assessment tool that will be used is called the Bayley Scales of Infant and&#xD;
      Toddler Development: 3rd Edition (Bayley-III) Screening Test. The results of this test will&#xD;
      then be compared to the child's HIE biomarkers concentrations already obtained at birth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">December 3, 2018</completion_date>
  <primary_completion_date type="Actual">December 3, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Bayley-III developmental assessment in children, with Hypoxic Ischemic Encephalopathy (HIE) diagnosis at birth, at 18-20 months of age</measure>
    <time_frame>2 years</time_frame>
    <description>Compare Developmental Outcomes to HIE Biomarker concentrations at birth</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">21</enrollment>
  <condition>Hypoxic-Ischemic Encephalopathy</condition>
  <arm_group>
    <arm_group_label>Developmental outcomes</arm_group_label>
    <description>A developmental assessment (Bayley-III) of children 18-20 months who already enrolled in Florida Neonatal Neurologic Network. As part of this previous study, these children were born with Hypoxic Ischemic Encephalopathy (HIE) and underwent therapeutic cooling after birth.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Developmental Outcomes</intervention_name>
    <description>A Bayley-III developmental assessment will be performed study subjects at age 18-20 months</description>
    <arm_group_label>Developmental outcomes</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Biomarkers will be compared to developmental outcomes, however these blood samples were&#xD;
      already obtained through IRB#504-2011&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Children 18-20 months of age born with Hypoxic Ischemic Encephalopathy (HIE)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children already enrolled in IRB#504-2011&#xD;
&#xD;
          -  18-20 months of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>20 Months</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>January 2020</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>January 14, 2020</last_update_submitted>
  <last_update_submitted_qc>January 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</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>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <!-- 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/NCT02264808
org study id: IRB201400699
nct id: NCT02264808
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Determine whether the concentrations of UCH-L1 and GFAP measured in umbilical cord blood and
      in blood 0-6 hours postnatal accurately predict the extent of neurodevelopmental deficits
      and/or death at 18-20 months.
Children born with Hypoxic Ischemic Encephalopathy (HIE) and already enrolled in IRB
      #504-2011 will be seen for a developmental follow-up at 18-20 months of age. The
      developmental assessment tool that will be used is called the Bayley Scales of Infant and
      Toddler Development: 3rd Edition (Bayley-III) Screening Test. The results of this test will
      then be compared to the child's HIE biomarkers concentrations already obtained at birth.
observational model: Cohort
time perspective: Retrospective
measure: Bayley-III developmental assessment in children, with Hypoxic Ischemic Encephalopathy (HIE) diagnosis at birth, at 18-20 months of age
time frame: 2 years
description: Compare Developmental Outcomes to HIE Biomarker concentrations at birth
arm group label: Developmental outcomes
description: A developmental assessment (Bayley-III) of children 18-20 months who already enrolled in Florida Neonatal Neurologic Network. As part of this previous study, these children were born with Hypoxic Ischemic Encephalopathy (HIE) and underwent therapeutic cooling after birth.
intervention type: Other
intervention name: Developmental Outcomes
description: A Bayley-III developmental assessment will be performed study subjects at age 18-20 months
arm group label: Developmental outcomes
Biomarkers will be compared to developmental outcomes, however these blood samples were
      already obtained through IRB#504-2011
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Months
maximum age: 20 Months
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
mesh term: Hypoxia