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/NCT05994417</url>
    </required_header>
    <id_info>
      <org_study_id>275653</org_study_id>
      <nct_id>NCT05994417</nct_id>
    </id_info>
    <brief_title>Beyond Race: Objectively Assessed Skin Color and Its Association With Pulse Oximeter Bias in Critically Ill Infants</brief_title>
    <official_title>Objectively Assessed Skin Color and Its Association With Pulse Oximeter Bias in Critically Ill Infants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Arkansas Children's Hospital Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Arkansas Children's Hospital Research Institute</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>
        The overall objective of this proposal is to quantify the bias in pulse oximeter reported&#xD;
        oxygen saturation (SpO2) by evaluating its measures compared to the gold standard blood gas&#xD;
        measured arterial oxygen saturation (SaO2) across race and skin pigmentation. The main&#xD;
        question that the investigators intend to answer is whether&#xD;
  &#xD;
          1. There is greater pulse oximeter bias and subclinical hypoxemia in (1a) Black compared to&#xD;
             White infants, and (1b) dark versus light-pigmented infants&#xD;
  &#xD;
          2. This bias increases with gestational and postnatal maturation&#xD;
  &#xD;
          3. This bias is associated with adverse patient outcomes&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study investigators will conduct a prospective observational study involving 200 infants&#xD;
        (0-3 months age) and compare simultaneously obtained pulse oximeter readings (SpO2) and&#xD;
        co-oximeter measured blood gas arterial oxygen saturation (SaO2), among infants identified as&#xD;
        Non-Hispanic Black and Non-Hispanic White. The investigators will also obtain an objective&#xD;
        assessment of skin pigmentation using a non-invasive device, SkinColorCatch® (by Delfin&#xD;
        Technologies Ltd, Finland) that provides (1) a melanin index and (2) an objective six-point&#xD;
        categorization of skin color based on Individual Typology Angle (ITA). Therefore, the&#xD;
        investigators will measure the pulse oximeter bias (SpO2-SaO2) across infants identified as&#xD;
        Non-Hispanic Black and Non-Hispanic White, as well as among infants of various skin&#xD;
        pigmentation. For infants that have an arterial line for more than one week, the researchers&#xD;
        will measure pulse oximeter bias (SpO2-SaO2) on a weekly basis over time with skin maturation&#xD;
        and pigmentation changes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</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>Systematic Bias in pulse oximetry</measure>
      <time_frame>Within 5 seconds</time_frame>
      <description>The difference between the blood gas measured arterial oxygen saturation (SaO2) and pulse oximeter reported oxygen saturation (SpO2)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Occult Hypoxemia</measure>
      <time_frame>Within 5 seconds</time_frame>
      <description>The prevalence of occult hypoxemia defined as pulse oximeter reported oxygen saturation (SpO2) of greater than 90% when blood gas measured arterial oxygen saturation (SaO2) is less than 88%.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Pulse Oximetry</condition>
    <condition>Disparities</condition>
    <condition>Infants</condition>
    <arm_group>
      <arm_group_label>Non-Hispanic Black</arm_group_label>
      <description>Infants born to mothers identifying as Non-Hispanic Black</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-Hispanic White</arm_group_label>
      <description>Infants born to mothers identifying as Non-Hispanic White</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Infants across the spectrum of melanin index and ITA-based skin color classification</arm_group_label>
    </arm_group>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Arterial blood collected for routine clinical analysis of blood gas status&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          All preterm (i.e. infant less than 37 weeks gestation) and term infants (i.e. infants &gt;= 37&#xD;
          weeks gestation) that have an indwelling arterial line and are admitted to the ACH neonatal&#xD;
          intensive care unit (NICU) and cardiovascular intensive care unit (CVICU).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Signed Informed Consent&#xD;
  &#xD;
            -  Postnatal age less than 3 months corrected age&#xD;
  &#xD;
            -  Presence of an in-dwelling umbilical or peripheral arterial line&#xD;
  &#xD;
            -  Gestational age &gt;= 25 weeks&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known skin pigmentary disorders&#xD;
  &#xD;
            -  Significantly impaired skin integrity&#xD;
  &#xD;
            -  Systemic bruising due to birth trauma&#xD;
  &#xD;
            -  Circulatory shock within last 48 hours&#xD;
  &#xD;
            -  Infants of peri-viable gestation (22-24 weeks)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>3 Months</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Megha Sharma, MD MS</last_name>
      <phone>501-364-1028</phone>
      <email>msharma@uams.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dannis Armikarina, BSN, RN</last_name>
      <phone>501-296-1389</phone>
      <email>ArmikarinaDL@archildrens.org</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Arkansas Children's Hospital Research Institute</investigator_affiliation>
      <investigator_full_name>Megha Sharma</investigator_full_name>
      <investigator_title>Assistant Professor, Section of Neonatology, Department of Pediatrics, University of Arkansas for Medical Sciences, Arkansas Children's Hospital</investigator_title>
    </responsible_party>
    <keyword>pulse oximeter</keyword>
    <keyword>bias</keyword>
    <keyword>disparities</keyword>
    <keyword>infants</keyword>
    <keyword>premature</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Critical Illness</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05994417
  org study id: 275653
  nct id: NCT05994417
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The overall objective of this proposal is to quantify the bias in pulse oximeter reported
        oxygen saturation (SpO2) by evaluating its measures compared to the gold standard blood gas
        measured arterial oxygen saturation (SaO2) across race and skin pigmentation. The main
        question that the investigators intend to answer is whether
  
          1. There is greater pulse oximeter bias and subclinical hypoxemia in (1a) Black compared to
             White infants, and (1b) dark versus light-pigmented infants
  
          2. This bias increases with gestational and postnatal maturation
  
          3. This bias is associated with adverse patient outcomes
  The study investigators will conduct a prospective observational study involving 200 infants
        (0-3 months age) and compare simultaneously obtained pulse oximeter readings (SpO2) and
        co-oximeter measured blood gas arterial oxygen saturation (SaO2), among infants identified as
        Non-Hispanic Black and Non-Hispanic White. The investigators will also obtain an objective
        assessment of skin pigmentation using a non-invasive device, SkinColorCatch® (by Delfin
        Technologies Ltd, Finland) that provides (1) a melanin index and (2) an objective six-point
        categorization of skin color based on Individual Typology Angle (ITA). Therefore, the
        investigators will measure the pulse oximeter bias (SpO2-SaO2) across infants identified as
        Non-Hispanic Black and Non-Hispanic White, as well as among infants of various skin
        pigmentation. For infants that have an arterial line for more than one week, the researchers
        will measure pulse oximeter bias (SpO2-SaO2) on a weekly basis over time with skin maturation
        and pigmentation changes.
  observational model: Cohort
  time perspective: Prospective
  measure: Systematic Bias in pulse oximetry
  time frame: Within 5 seconds
  description: The difference between the blood gas measured arterial oxygen saturation (SaO2) and pulse oximeter reported oxygen saturation (SpO2)
  measure: Occult Hypoxemia
  time frame: Within 5 seconds
  description: The prevalence of occult hypoxemia defined as pulse oximeter reported oxygen saturation (SpO2) of greater than 90% when blood gas measured arterial oxygen saturation (SaO2) is less than 88%.
  arm group label: Non-Hispanic Black
  description: Infants born to mothers identifying as Non-Hispanic Black
  arm group label: Non-Hispanic White
  description: Infants born to mothers identifying as Non-Hispanic White
  arm group label: Infants across the spectrum of melanin index and ITA-based skin color classification
  Arterial blood collected for routine clinical analysis of blood gas status
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 3 Months
  healthy volunteers: No
  last name: Megha Sharma, MD MS
  phone: 501-364-1028
  email: msharma@uams.edu
  last name: Dannis Armikarina, BSN, RN
  phone: 501-296-1389
  email: ArmikarinaDL@archildrens.org
  responsible party type: Principal Investigator
  investigator affiliation: Arkansas Children's Hospital Research Institute
  investigator full name: Megha Sharma
  investigator title: Assistant Professor, Section of Neonatology, Department of Pediatrics, University of Arkansas for Medical Sciences, Arkansas Children's Hospital
  mesh term: Critical Illness
  sharing ipd: Undecided