xml: <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/NCT05971446</url>
    </required_header>
    <id_info>
      <org_study_id>2019-1243</org_study_id>
      <secondary_id>SMPH\PEDIATRICS\PICU</secondary_id>
      <secondary_id>Protocol Version 3/31/2023</secondary_id>
      <nct_id>NCT05971446</nct_id>
    </id_info>
    <brief_title>Healthy Little Eyes</brief_title>
    <official_title>Visual Function as a Novel Outcome Measure Following Neonatal Hypoxic Ischemic Encephalopathy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Wisconsin, Madison</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Meriter Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Wisconsin, Madison</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this research study is to gather more information on how eye injury is related&#xD;
        to a baby's future development and see if eye function and brain test results can be used,&#xD;
        along with current measures, to better diagnose and treat babies with hypoxic-ischemic&#xD;
        encephalopathy (HIE).&#xD;
  &#xD;
        Participants will undergo up to two eye exam sessions, involving both Visual Evoked Potential&#xD;
        (VEP) and Electroretinogram (ERG) exams.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 24, 2020</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To evaluate the correlation between retinal function and neurodevelopmental outcomes</measure>
      <time_frame>Through 30 months of life</time_frame>
      <description>The least absolute shrinkage and selection operator technique will be utilized to determine whether ERG measures predict neurodevelopmental outcomes</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To evaluate the correlation between retinal function and neuroimaging outcomes</measure>
      <time_frame>Within first 5 days of life</time_frame>
      <description>The least absolute shrinkage and selection operator technique will be utilized to determine whether ERG measures predict neuroimaging outcomes</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To evaluate the correlation between visual cortical function and neurodevelopmental outcomes</measure>
      <time_frame>Through 30 months of life</time_frame>
      <description>The least absolute shrinkage and selection operator technique will be utilized to determine whether VEP measures predict neurodevelopmental outcomes</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To evaluate the correlation between visual cortical function and neuroimaging outcomes</measure>
      <time_frame>Within first 5 days of life</time_frame>
      <description>The least absolute shrinkage and selection operator technique will be utilized to determine whether VEP measures predict neuroimaging outcomes</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Compare ERG results between healthy babies and babies with HIE</measure>
      <time_frame>Within first 5 days of life</time_frame>
      <description>The ERG results from healthy babies will be compared to those of babies with HIE</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Report Shape of the VEP results for healthy babies and babies with HIE</measure>
      <time_frame>Within first 5 days of life</time_frame>
      <description>The shape of the waveform will be reported as a categorical variable: sharp, slanted, blunt, or multiple peaks</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Compare Amplitude of the VEP results between healthy babies and babies with HIE</measure>
      <time_frame>Within first 5 days of life</time_frame>
      <description>The amplitude will be reported as differences in microvolt responses between groups.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Compare Latency of the VEP results between healthy babies and babies with HIE</measure>
      <time_frame>Within first 5 days of life</time_frame>
      <description>The latency will be reported as differences in timing (measured in milliseconds) between groups.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Compare Transocular Shape, Amplitude, and Latency Difference of the VEP results between healthy babies and babies with HIE</measure>
      <time_frame>Within first 5 days of life</time_frame>
      <description>The Transocular Shape Difference will be reported as differences in shape between the two eyes compared across groups, reported as a categorical variable: sharp, slanted, blunt, or multiple peaks.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">125</enrollment>
    <condition>Hypoxic-Ischemic Encephalopathy</condition>
    <condition>Neonatal Encephalopathy</condition>
    <condition>Encephalopathy</condition>
    <arm_group>
      <arm_group_label>Participants with HIE</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy participants</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Visual Evoked Potential (VEP)</intervention_name>
      <description>Small gold-cup electrodes will be placed on the participant's head using a small dot of adhesive paste. The handheld device is then connected to the electrodes, and the participant's eyes are exposed to a light flicker. Each eye will be tested separately, and while testing one eye, the other eye may be patched.</description>
      <arm_group_label>Healthy participants</arm_group_label>
      <arm_group_label>Participants with HIE</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Electroretinogram (ERG)</intervention_name>
      <description>Skin electrodes will be placed under each eye. Eyes will then be exposed to a flashing light. Each eye will be tested separately and while testing one eye, the other eye may be patched.</description>
      <arm_group_label>Healthy participants</arm_group_label>
      <arm_group_label>Participants with HIE</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          1. HIE Neonates in the NICU at AFCH or Meriter who are less than 78 hours old&#xD;
  &#xD;
            2. HIE Neonates at Waisman, AFCH Newborn Follow-up Clinic, or CERU Clinic who are less&#xD;
               than 78 hours old&#xD;
  &#xD;
            3. Well babies at the Meriter Newborn Nursery who are less than 36 months of age&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          HIE Neonate Inclusion Criteria:&#xD;
  &#xD;
            -  Inpatient Neonates diagnosed with HIE&#xD;
  &#xD;
            -  Pediatric patients who are less than 78 hours of age at the time of enrollment&#xD;
  &#xD;
            -  Participants whose parent/legal guardian is able to complete consenting process in&#xD;
               English&#xD;
  &#xD;
          HIE Neonate Exclusion Criteria:&#xD;
  &#xD;
            -  Participants with prenatally diagnosed or congenital brain and/or eye abnormalities&#xD;
               not associated with HIE, including but not limited to microphthalmia, anophthalmia,&#xD;
               congenital cataract, eye or eyelid coloboma, congenital glaucoma, CMV retinitis, optic&#xD;
               nerve hypoplasia, aniridia, cryptophthalmos, globe abnormalities&#xD;
  &#xD;
            -  Participants who have a known central nervous system illness other than HIE, including&#xD;
               but not limited to congenital brain malformations or congenital hydrocephalus&#xD;
  &#xD;
            -  Participants whose parent/legal guardian is unable to provide informed consent,&#xD;
               including participants who are in foster care, participants within state custody, and&#xD;
               participants of minor parents&#xD;
  &#xD;
          Waisman, AFCH NBFU, or CERU Clinic HIE Patient Inclusion Criteria:&#xD;
  &#xD;
            -  Pediatric patients who have a diagnosis of HIE and present to the Newborn Follow Up&#xD;
               Clinic&#xD;
  &#xD;
            -  Pediatric patients who are less than 36 months of age at the time of enrollment&#xD;
  &#xD;
            -  Participants whose parent/legal guardian is able to complete consenting process in&#xD;
               English&#xD;
  &#xD;
          Waisman, AFCH NBFU, or CERU Clinic HIE Patient Exclusion Criteria:&#xD;
  &#xD;
            -  Participants with prenatally diagnosed or congenital brain and/or eye abnormalities&#xD;
               not associated with HIE, including but not limited to microphthalmia, anophthalmia,&#xD;
               congenital cataract, eye or eyelid coloboma, congenital glaucoma, CMV retinitis, optic&#xD;
               nerve hypoplasia, aniridia, cryptophthalmos, globe abnormalities&#xD;
  &#xD;
            -  Participants who have a known central nervous system illness not associated with HIE&#xD;
               and its complications. Complications may include seizures, hydrocephalus, and stroke,&#xD;
               which are NOT exclusionary. Examples of exclusionary conditions include but are not&#xD;
               limited to traumatic brain injury outside the perinatal period, meningitis, or&#xD;
               diagnosis of brain tumor&#xD;
  &#xD;
            -  Participants whose parent/legal guardian is unable to provide informed consent,&#xD;
               including participants who are in foster care, participants within state custody, and&#xD;
               participants of minor parents&#xD;
  &#xD;
          Well Baby Inclusion Criteria:&#xD;
  &#xD;
            -  Patient in Meriter's Newborn Nursery&#xD;
  &#xD;
            -  ≥37 and &lt;42 weeks gestational age&#xD;
  &#xD;
            -  5-minute Apgar Score ≥7&#xD;
  &#xD;
            -  Occipital Frontal Circumference (OFC) is within average limits for age (&lt;97th&#xD;
               percentile and &gt;3rd percentile)&#xD;
  &#xD;
          Well Baby Exclusion Criteria:&#xD;
  &#xD;
            -  Admitted to the NICU for any reason&#xD;
  &#xD;
            -  Known genetic abnormality&#xD;
  &#xD;
            -  Diagnosed with HIE&#xD;
  &#xD;
            -  Diagnosed with Hypoglycemia&#xD;
  &#xD;
            -  Diagnosed with Hyperbilirubinemia requiring phototherapy&#xD;
  &#xD;
            -  Identified prenatal exposure to substances, including illicit drugs, alcohol, and/or&#xD;
               tobacco&#xD;
  &#xD;
            -  Known or suspected neonatal infection requiring treatment (e.g., antibiotics)&#xD;
  &#xD;
            -  TORCH infections&#xD;
  &#xD;
            -  Abnormal newborn hearing screen&#xD;
  &#xD;
            -  Abnormal toxicology screening&#xD;
  &#xD;
            -  Identified as large for gestational age (LGA) or small for gestational age (SGA)&#xD;
  &#xD;
            -  Participants with prenatally diagnosed or congenital eye abnormalities, including but&#xD;
               not limited to microphthalmia, anophthalmia, congenital cataract, eye or eyelid&#xD;
               coloboma, congenital glaucoma, CMV retinitis, optic nerve hypoplasia, aniridia,&#xD;
               cryptophthalmos, globe abnormalities, and nystagmus&#xD;
  &#xD;
            -  Subjects who have a known central nervous system illness or malformation, including&#xD;
               but not limited to congenital brain malformations or congenital hydrocephalus&#xD;
  &#xD;
            -  Participants whose parent/legal guardian is unable to provide informed consent,&#xD;
               including subjects who are in foster care, subjects within state custody, and subjects&#xD;
               of minor parents&#xD;
  &#xD;
            -  The attending medical team does not approve&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>36 Months</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pelin Cengiz, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Wisconsin, Madison</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alexandra Lindstrom</last_name>
      <phone>608-262-2388</phone>
      <email>aklindstrom2@wisc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Wisconsin</name>
        <address>
          <city>Madison</city>
          <state>Wisconsin</state>
          <zip>53705</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alexandra Lindstrom</last_name>
        <email>aklinidstrom2@wisc.edu</email>
      </contact>
      <investigator>
        <last_name>Pelin Cengiz, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>neonatal</keyword>
    <keyword>visual evoked potential</keyword>
    <keyword>electroretinogram</keyword>
    <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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971446
  org study id: 2019-1243
  secondary id: SMPH\PEDIATRICS\PICU
  secondary id: Protocol Version 3/31/2023
  nct id: NCT05971446
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: Yes
  The purpose of this research study is to gather more information on how eye injury is related
        to a baby's future development and see if eye function and brain test results can be used,
        along with current measures, to better diagnose and treat babies with hypoxic-ischemic
        encephalopathy (HIE).
  
        Participants will undergo up to two eye exam sessions, involving both Visual Evoked Potential
        (VEP) and Electroretinogram (ERG) exams.
  observational model: Case-Control
  time perspective: Prospective
  measure: To evaluate the correlation between retinal function and neurodevelopmental outcomes
  time frame: Through 30 months of life
  description: The least absolute shrinkage and selection operator technique will be utilized to determine whether ERG measures predict neurodevelopmental outcomes
  measure: To evaluate the correlation between retinal function and neuroimaging outcomes
  time frame: Within first 5 days of life
  description: The least absolute shrinkage and selection operator technique will be utilized to determine whether ERG measures predict neuroimaging outcomes
  measure: To evaluate the correlation between visual cortical function and neurodevelopmental outcomes
  time frame: Through 30 months of life
  description: The least absolute shrinkage and selection operator technique will be utilized to determine whether VEP measures predict neurodevelopmental outcomes
  measure: To evaluate the correlation between visual cortical function and neuroimaging outcomes
  time frame: Within first 5 days of life
  description: The least absolute shrinkage and selection operator technique will be utilized to determine whether VEP measures predict neuroimaging outcomes
  measure: Compare ERG results between healthy babies and babies with HIE
  time frame: Within first 5 days of life
  description: The ERG results from healthy babies will be compared to those of babies with HIE
  measure: Report Shape of the VEP results for healthy babies and babies with HIE
  time frame: Within first 5 days of life
  description: The shape of the waveform will be reported as a categorical variable: sharp, slanted, blunt, or multiple peaks
  measure: Compare Amplitude of the VEP results between healthy babies and babies with HIE
  time frame: Within first 5 days of life
  description: The amplitude will be reported as differences in microvolt responses between groups.
  measure: Compare Latency of the VEP results between healthy babies and babies with HIE
  time frame: Within first 5 days of life
  description: The latency will be reported as differences in timing (measured in milliseconds) between groups.
  measure: Compare Transocular Shape, Amplitude, and Latency Difference of the VEP results between healthy babies and babies with HIE
  time frame: Within first 5 days of life
  description: The Transocular Shape Difference will be reported as differences in shape between the two eyes compared across groups, reported as a categorical variable: sharp, slanted, blunt, or multiple peaks.
  arm group label: Participants with HIE
  arm group label: Healthy participants
  intervention type: Device
  intervention name: Visual Evoked Potential (VEP)
  description: Small gold-cup electrodes will be placed on the participant's head using a small dot of adhesive paste. The handheld device is then connected to the electrodes, and the participant's eyes are exposed to a light flicker. Each eye will be tested separately, and while testing one eye, the other eye may be patched.
  arm group label: Healthy participants
  arm group label: Participants with HIE
  intervention type: Device
  intervention name: Electroretinogram (ERG)
  description: Skin electrodes will be placed under each eye. Eyes will then be exposed to a flashing light. Each eye will be tested separately and while testing one eye, the other eye may be patched.
  arm group label: Healthy participants
  arm group label: Participants with HIE
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 36 Months
  healthy volunteers: Accepts Healthy Volunteers
  last name: Pelin Cengiz, MD
  role: Principal Investigator
  affiliation: University of Wisconsin, Madison
  last name: Alexandra Lindstrom
  phone: 608-262-2388
  email: aklindstrom2@wisc.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Brain Diseases
  mesh term: Brain Ischemia
  mesh term: Hypoxia-Ischemia, Brain
  mesh term: Hypoxia
  sharing ipd: No