<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/NCT04439968</url>
  </required_header>
  <id_info>
    <org_study_id>56759</org_study_id>
    <nct_id>NCT04439968</nct_id>
  </id_info>
  <brief_title>Neonatal Brain Oxygenation Study</brief_title>
  <acronym>BOX</acronym>
  <official_title>Targeted Cerebral Saturations in Extremely Preterm Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Implementing target ranges for regional cerebral saturations in extremely preterm infants in&#xD;
      the first week of life may improve neurodevelopmental outcomes at 22-26 months corrected age&#xD;
      compared to those without targeted cerebral saturations (Csat) using near-infrared&#xD;
      spectroscopy (NIRS). Infants will be randomized to a targeted cerebral saturation monitoring&#xD;
      group with visible reading of Csat or to a control group with cerebral saturation monitoring,&#xD;
      but with blinded Csat measures. Those in the targeted Csat group will follow a treatment&#xD;
      guideline to maintain cerebral oxygenation in the target range. The primary outcome is&#xD;
      neurodevelopmental outcome as determined by Bayley III cognitive scale score.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 10, 2021</start_date>
  <completion_date type="Anticipated">August 2025</completion_date>
  <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>randomized to 2 groups: Targeted NIRS monitoring vs Non-targeted, blinded NIRS monitoring</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Assessors of neurodevelopmental outcome are blinded to targeted vs non-targeted monitoring</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Neurodevelopmental outcome</measure>
    <time_frame>22-26 months of age</time_frame>
    <description>Neurodevelopmental outcomes will be assessed using the cognitive component of the Bayley Scales of Infant Development-III at 22-26 months of age. Scores range from 55-145 with higher number representing a better neurodevelopmental outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>from birth until hospital discharge, an average of 3 months.</time_frame>
    <description>Death prior to hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinopathy of prematurity</measure>
    <time_frame>from birth until hospital discharge, an average of 3 months.</time_frame>
    <description>Occurrence of retinopathy of prematurity prior to hospital discharge</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Burden of Cerebral hypoxia or hyperoxia</measure>
    <time_frame>From birth until first 7 days of life</time_frame>
    <description>Burden of cerebral hypoxia or hyperoxia from NIRS measures</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Cerebral Hypoxia</condition>
  <arm_group>
    <arm_group_label>Targeted Csats</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to the targeted Csat arm will have NIRS monitoring of cerebral saturations (Csat) and will have algorithm-driven clinical interventions to maintain Csat within target range in the first week of life.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-targeted Csats</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects randomized to the non-targeted Csat arm will have NIRS (near-infrared spectroscopy) monitoring of Csats, but Csat values will be obscured and not available to providers. These subjects will not have any algorithm-driven clinical interventions for Csat.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical algorithm</intervention_name>
    <description>In order to maintain cerebral saturations within targeted range, subjects in the targeted Csat arm will undergo clinical interventions based on clinical algorithm. Interventions may include administration of inotropes, fluid resuscitation, transfusion of blood products, and/or adjustment to respiratory support.</description>
    <arm_group_label>Targeted Csats</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Very preterm infants with gestational age at least 23 weeks but less than 29 completed&#xD;
             weeks&#xD;
&#xD;
          -  Less than 6 hours of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Skin integrity insufficient to allow placement of NIRS sensors&#xD;
&#xD;
          -  Decision not to provide full intensive care support&#xD;
&#xD;
          -  Congenital condition, other than premature birth, that adversely affects life&#xD;
             expectancy or neurodevelopment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>2 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Lucile Packard Children's Hospital Stanford</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>November 9, 2022</last_update_submitted>
  <last_update_submitted_qc>November 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Valerie Chock, M.D., M.S. Epi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoxia, Brain</mesh_term>
    <mesh_term>Hypoxia</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/NCT04439968
org study id: 56759
nct id: NCT04439968
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Implementing target ranges for regional cerebral saturations in extremely preterm infants in
      the first week of life may improve neurodevelopmental outcomes at 22-26 months corrected age
      compared to those without targeted cerebral saturations (Csat) using near-infrared
      spectroscopy (NIRS). Infants will be randomized to a targeted cerebral saturation monitoring
      group with visible reading of Csat or to a control group with cerebral saturation monitoring,
      but with blinded Csat measures. Those in the targeted Csat group will follow a treatment
      guideline to maintain cerebral oxygenation in the target range. The primary outcome is
      neurodevelopmental outcome as determined by Bayley III cognitive scale score.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized to 2 groups: Targeted NIRS monitoring vs Non-targeted, blinded NIRS monitoring
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
masking description: Assessors of neurodevelopmental outcome are blinded to targeted vs non-targeted monitoring
measure: Neurodevelopmental outcome
time frame: 22-26 months of age
description: Neurodevelopmental outcomes will be assessed using the cognitive component of the Bayley Scales of Infant Development-III at 22-26 months of age. Scores range from 55-145 with higher number representing a better neurodevelopmental outcome.
measure: Death
time frame: from birth until hospital discharge, an average of 3 months.
description: Death prior to hospital discharge
measure: Retinopathy of prematurity
time frame: from birth until hospital discharge, an average of 3 months.
description: Occurrence of retinopathy of prematurity prior to hospital discharge
measure: Burden of Cerebral hypoxia or hyperoxia
time frame: From birth until first 7 days of life
description: Burden of cerebral hypoxia or hyperoxia from NIRS measures
arm group label: Targeted Csats
arm group type: Active Comparator
description: Subjects randomized to the targeted Csat arm will have NIRS monitoring of cerebral saturations (Csat) and will have algorithm-driven clinical interventions to maintain Csat within target range in the first week of life.
arm group label: Non-targeted Csats
arm group type: No Intervention
description: Subjects randomized to the non-targeted Csat arm will have NIRS (near-infrared spectroscopy) monitoring of Csats, but Csat values will be obscured and not available to providers. These subjects will not have any algorithm-driven clinical interventions for Csat.
intervention type: Other
intervention name: Clinical algorithm
description: In order to maintain cerebral saturations within targeted range, subjects in the targeted Csat arm will undergo clinical interventions based on clinical algorithm. Interventions may include administration of inotropes, fluid resuscitation, transfusion of blood products, and/or adjustment to respiratory support.
arm group label: Targeted Csats
criteria: 
gender: All
minimum age: N/A
maximum age: 2 Days
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Valerie Chock, M.D., M.S. Epi
investigator title: Principal Investigator
mesh term: Hypoxia, Brain
mesh term: Hypoxia
sharing ipd: Undecided