<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/NCT03284528</url>
  </required_header>
  <id_info>
    <org_study_id>2017-00912</org_study_id>
    <nct_id>NCT03284528</nct_id>
  </id_info>
  <brief_title>Does Placenta Pathology Predict Outcome of Neonates With Hypoxic Ischemic Encephalopathy?&quot;</brief_title>
  <official_title>Does Placenta Pathology Predict Outcome of Neonates With Hypoxic Ischemic Encephalopathy?&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Children's Hospital, Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Children's Hospital, Zurich</source>
  <oversight_info>
    <has_dmc>Yes</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 histology of the placenta of newborn infants with perinatal asphyxia and&#xD;
      hypoxic-ischaemic encephalopathy is analysed. There will be an evaluation if placenta could&#xD;
      be a biomarker for neurodevelopmental outcome at 18-24 months of age.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2011</start_date>
  <completion_date type="Actual">January 1, 2017</completion_date>
  <primary_completion_date type="Actual">January 1, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>neurodevelopmental outcome at 18-24 month of Age</measure>
    <time_frame>7 years</time_frame>
    <description>The investigators will analyse if there is a correlation of placenta histology and neurodevelopmental outcome</description>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Asphyxia Neonatorum</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>hypothermia therapy</intervention_name>
    <description>newborn infants with hypoxic-ischaemic encephalopathy are cooled for 72 hours with a target temperature of 33-34°C (whole body cooling).</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All newborn infants with a gestational Age &gt;35 weeks, fulfilling the inclusion criteria of&#xD;
        perinatal asphyxia and hypoxic-ischaemic encephalopathy, born in Switzerland and treated in&#xD;
        the University Hospital of Zurich with hypothermia therapy after birth&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:all newborn infants with APGAR &lt;5 at 10minutes, pH&lt;7.0, lactate&#xD;
        &gt;12mmol/L, base excess &gt;16, resuscitation &gt;10min after birth, gestational age &gt;35 weeks and&#xD;
        an encephalopathy -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>4 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barbara Brotschi</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Childrens's hospital of Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Children's hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8044</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>September 20, 2017</last_update_submitted>
  <last_update_submitted_qc>September 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2017</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>Asphyxia Neonatorum</mesh_term>
    <mesh_term>Asphyxia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03284528
org study id: 2017-00912
nct id: NCT03284528
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The histology of the placenta of newborn infants with perinatal asphyxia and
      hypoxic-ischaemic encephalopathy is analysed. There will be an evaluation if placenta could
      be a biomarker for neurodevelopmental outcome at 18-24 months of age.
observational model: Cohort
time perspective: Retrospective
measure: neurodevelopmental outcome at 18-24 month of Age
time frame: 7 years
description: The investigators will analyse if there is a correlation of placenta histology and neurodevelopmental outcome
intervention type: Other
intervention name: hypothermia therapy
description: newborn infants with hypoxic-ischaemic encephalopathy are cooled for 72 hours with a target temperature of 33-34°C (whole body cooling).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 4 Days
healthy volunteers: No
last name: Barbara Brotschi
role: Principal Investigator
affiliation: University Childrens's hospital of Zurich
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Brain Diseases
mesh term: Brain Ischemia
mesh term: Hypoxia-Ischemia, Brain
mesh term: Asphyxia Neonatorum
mesh term: Asphyxia
sharing ipd: No