<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/NCT03835039</url>
  </required_header>
  <id_info>
    <org_study_id>5120</org_study_id>
    <nct_id>NCT03835039</nct_id>
  </id_info>
  <brief_title>The Ability of NIRS to Predict Brain Injury in Hypoxic Ischemic Encephalopathy</brief_title>
  <official_title>The Ability of Near Infrared Spectroscopy Monitoring During Hypothermia Treatment to Predict Brain Injury in Infants With Hypoxic Ischemic Encephalopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albany Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Albany Medical College</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A longitudinal study evaluating the predictive ability of near infrared spectroscopy to&#xD;
      predict brain injury in infants with hypoxic ischemic encephalopathy. Data will be analyzed&#xD;
      at two different time periods, at discharge and again at 2 years of age.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Interim analysis not showing significant results&#xD;
  </why_stopped>
  <start_date type="Actual">January 3, 2019</start_date>
  <completion_date type="Actual">January 1, 2022</completion_date>
  <primary_completion_date type="Actual">January 1, 2022</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>MRI findings of encephalopathy</measure>
    <time_frame>6 days</time_frame>
    <description>MRI studies will be reviewed and assessed for markers of HIE including damage to deep grey matter structures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurodevelopment at 2 years of age</measure>
    <time_frame>2 years</time_frame>
    <description>Bayleys developmental test will be used to categorize the infants' neurodevelopment at 2 years of age.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">101</enrollment>
  <condition>HIE - Perinatal Hypoxic - Ischemic Encephalopathy</condition>
  <arm_group>
    <arm_group_label>HIE</arm_group_label>
    <description>Infants with a diagnosis of HIE</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NIRS</intervention_name>
    <description>Monitoring cerebral and perirenal perfusion using NIRS</description>
    <arm_group_label>HIE</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Newborn infants with diagnosis of HIE&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants with diagnosis at birth of HIE&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Minute</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Albany Medical Center Neonatal Intesive Care Unit</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>February 28, 2022</last_update_submitted>
  <last_update_submitted_qc>February 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2022</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 Injuries</mesh_term>
    <mesh_term>Brain Diseases</mesh_term>
    <mesh_term>Brain Ischemia</mesh_term>
    <mesh_term>Hypoxia-Ischemia, Brain</mesh_term>
    <mesh_term>Ischemia</mesh_term>
    <mesh_term>Hypoxia</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/NCT03835039
org study id: 5120
nct id: NCT03835039
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
A longitudinal study evaluating the predictive ability of near infrared spectroscopy to
      predict brain injury in infants with hypoxic ischemic encephalopathy. Data will be analyzed
      at two different time periods, at discharge and again at 2 years of age.
observational model: Cohort
time perspective: Prospective
measure: MRI findings of encephalopathy
time frame: 6 days
description: MRI studies will be reviewed and assessed for markers of HIE including damage to deep grey matter structures.
measure: Neurodevelopment at 2 years of age
time frame: 2 years
description: Bayleys developmental test will be used to categorize the infants' neurodevelopment at 2 years of age.
arm group label: HIE
description: Infants with a diagnosis of HIE
intervention type: Device
intervention name: NIRS
description: Monitoring cerebral and perirenal perfusion using NIRS
arm group label: HIE
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Minute
maximum age: 2 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Diseases
mesh term: Brain Ischemia
mesh term: Hypoxia-Ischemia, Brain
mesh term: Ischemia
mesh term: Hypoxia
sharing ipd: No