<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/NCT03246503</url>
  </required_header>
  <id_info>
    <org_study_id>52488</org_study_id>
    <secondary_id>R44HD090778</secondary_id>
    <nct_id>NCT03246503</nct_id>
  </id_info>
  <brief_title>BiliCam Clinical Validation Study</brief_title>
  <official_title>BiliCam Clinical Validation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BiliCam, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>BiliCam, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to assess the accuracy of BiliCam, a non-invasive technology based&#xD;
      on analysis of digital images obtained with an app installed on a commercial smartphone, in&#xD;
      estimating total serum bilirubin levels in newborns. BiliCam estimated bilirubin levels will&#xD;
      be compared to total serum bilirubin levels in up to 225 newborns.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Jaundice, a yellowing of the skin and eyes caused by a build up of bilirubin in the blood, is&#xD;
      a common problem in newborn infants. Measurement of total serum bilirubin (TSB) levels is&#xD;
      used for clinical decision making. BiliCam is a non-invasive technology used to estimate TSB&#xD;
      levels in newborns. With BiliCam, the user obtains digital images of a small portion of a&#xD;
      newborn's skin using the BiliCam app installed on a commercial smartphone in a standardized&#xD;
      manner. A color calibration card is placed on the baby's sternum to account for varying light&#xD;
      conditions. Data on color levels in the photos are used to estimate a bilirubin level.&#xD;
&#xD;
      For the study, paired BiliCam estimated bilirubin (BCB) and TSB levels will be compared on a&#xD;
      racially and ethnically diverse sample of newborns. Recruitment will continue until 225&#xD;
      newborns have completed the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2017</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 2018</primary_completion_date>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BCB - TSB Correlation</measure>
    <time_frame>Newborns up to 192 hours old</time_frame>
    <description>Pearson correlation coefficient between paired BCB- TSB measurements</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intercept of Regression Line</measure>
    <time_frame>Newborns up to 192 hours old</time_frame>
    <description>The intercept of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Slope of Regression Line</measure>
    <time_frame>Newborns up to 192 hours old</time_frame>
    <description>The slope of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">203</enrollment>
  <condition>Newborn Jaundice</condition>
  <arm_group>
    <arm_group_label>Newborns</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Newborns will be enrolled in the study in 2 different ways. At &quot;Staged Enrollment&quot; sites, newborns will be enrolled when they are &lt; 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At &quot;Simultaneous Enrollment&quot; sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BiliCam estimated bilirubin (BCB)</intervention_name>
    <description>Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care</description>
    <arm_group_label>Newborns</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newborn born at ≥ 35 weeks gestation&#xD;
&#xD;
          -  Parent speaks and reads English&#xD;
&#xD;
          -  Parent provides written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous or ongoing treatment with phototherapy for hyperbilirubinemia&#xD;
&#xD;
          -  Medical or other complications that preclude completion of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Hours</minimum_age>
    <maximum_age>191 Hours</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Thomas Jefferson University Hopsital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <results_first_submitted>March 17, 2022</results_first_submitted>
  <results_first_submitted_qc>June 8, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 9, 2022</results_first_posted>
  <disposition_first_submitted>July 8, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>June 8, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 9, 2022</disposition_first_posted>
  <last_update_submitted>June 8, 2022</last_update_submitted>
  <last_update_submitted_qc>June 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 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>Jaundice, Neonatal</mesh_term>
    <mesh_term>Jaundice</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bilirubin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT03246503/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Newborns</title>
          <description>Newborns will be enrolled in the study in 2 different ways. At &quot;Staged Enrollment&quot; sites, newborns will be enrolled when they are &lt; 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At &quot;Simultaneous Enrollment&quot; sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.&#xD;
BiliCam estimated bilirubin (BCB): Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="203"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="150"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Received phtototherapy prior to study visit=4, blood specimen not obtained =1</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Age was only measured on the 150 participants who completed a study visit</population>
      <group_list>
        <group group_id="B1">
          <title>Newborns</title>
          <description>Newborns will be enrolled in the study in 2 different ways. At &quot;Staged Enrollment&quot; sites, newborns will be enrolled when they are &lt; 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At &quot;Simultaneous Enrollment&quot; sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.&#xD;
BiliCam estimated bilirubin (BCB): Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="203"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>A total of 203 participants were consented. Age was not obtained until the study visit; 150 participants had a study visit</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="95.7" spread="27.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="160"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="203"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="203"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>BCB - TSB Correlation</title>
        <description>Pearson correlation coefficient between paired BCB- TSB measurements</description>
        <time_frame>Newborns up to 192 hours old</time_frame>
        <population>Participants who completed study visit and had valid paired TSB-BCB results. There were 3 participants in whom blood was obtained for TSB levels, but no valid measurement was available (1 grossly hemolyzed sample, 1 specimen lost, and 1 specimen not obtained within 2 hours of the BCB level). There were 3 participants in whom a BCB level could not be obtained by the study device.</population>
        <group_list>
          <group group_id="O1">
            <title>Newborns</title>
            <description>Newborns will be enrolled in the study in 2 different ways. At &quot;Staged Enrollment&quot; sites, newborns will be enrolled when they are &lt; 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At &quot;Simultaneous Enrollment&quot; sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.&#xD;
BiliCam estimated bilirubin (BCB): Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care</description>
          </group>
        </group_list>
        <measure>
          <title>BCB - TSB Correlation</title>
          <description>Pearson correlation coefficient between paired BCB- TSB measurements</description>
          <population>Participants who completed study visit and had valid paired TSB-BCB results. There were 3 participants in whom blood was obtained for TSB levels, but no valid measurement was available (1 grossly hemolyzed sample, 1 specimen lost, and 1 specimen not obtained within 2 hours of the BCB level). There were 3 participants in whom a BCB level could not be obtained by the study device.</population>
          <units>correlation coefficient</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Bootstrapping with 1000 replications was used to estimate 95% confidence intervals.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <p_value_desc>statistical significance of Pearson correlation coefficient</p_value_desc>
            <method>Pearson correlation coefficient</method>
            <param_type>Pearson correlation coefficient</param_type>
            <param_value>0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>.87</ci_upper_limit>
            <estimate_desc>Bootstrapping with 1000 replications was used to estimate 95% confidence intervals.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intercept of Regression Line</title>
        <description>The intercept of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).</description>
        <time_frame>Newborns up to 192 hours old</time_frame>
        <population>Participants with valid paired BCB and TSB values</population>
        <group_list>
          <group group_id="O1">
            <title>Newborns</title>
            <description>Newborns will be enrolled in the study in 2 different ways. At &quot;Staged Enrollment&quot; sites, newborns will be enrolled when they are &lt; 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At &quot;Simultaneous Enrollment&quot; sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.&#xD;
BiliCam estimated bilirubin (BCB): Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care</description>
          </group>
        </group_list>
        <measure>
          <title>Intercept of Regression Line</title>
          <description>The intercept of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).</description>
          <population>Participants with valid paired BCB and TSB values</population>
          <units>mg/dL</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.13" lower_limit="3.35" upper_limit="4.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>t-statistic from regression analysis</non_inferiority_desc>
            <p_value>&lt;.001</p_value>
            <method>Regression, Linear</method>
            <param_type>intercept of regression line</param_type>
            <param_value>4.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.35</ci_lower_limit>
            <ci_upper_limit>4.91</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Slope of Regression Line</title>
        <description>The slope of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).</description>
        <time_frame>Newborns up to 192 hours old</time_frame>
        <population>Participants with valid paired BCB and TSB values</population>
        <group_list>
          <group group_id="O1">
            <title>Newborns</title>
            <description>Newborns will be enrolled in the study in 2 different ways. At &quot;Staged Enrollment&quot; sites, newborns will be enrolled when they are &lt; 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At &quot;Simultaneous Enrollment&quot; sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.&#xD;
BiliCam estimated bilirubin (BCB): Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care</description>
          </group>
        </group_list>
        <measure>
          <title>Slope of Regression Line</title>
          <description>The slope of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).</description>
          <population>Participants with valid paired BCB and TSB values</population>
          <units>slope</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.68" lower_limit="0.60" upper_limit="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>t-statistic from regression analysis</non_inferiority_desc>
            <p_value>&lt;.001</p_value>
            <method>Regression, Linear</method>
            <param_type>Slope</param_type>
            <param_value>0.68</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>0.76</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events related to the study device through study completion, for an average of 30 minutes</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Newborns</title>
          <description>Newborns will be enrolled in the study in 2 different ways. At &quot;Staged Enrollment&quot; sites, newborns will be enrolled when they are &lt; 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At &quot;Simultaneous Enrollment&quot; sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.&#xD;
BiliCam estimated bilirubin (BCB): Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>James Taylor</name_or_title>
      <organization>BiliCam, LLC</organization>
      <phone>2064194923</phone>
      <email>uncjat@google.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03246503
org study id: 52488
secondary id: R44HD090778
nct id: NCT03246503
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is unapproved device: Yes
The goal of this study is to assess the accuracy of BiliCam, a non-invasive technology based
      on analysis of digital images obtained with an app installed on a commercial smartphone, in
      estimating total serum bilirubin levels in newborns. BiliCam estimated bilirubin levels will
      be compared to total serum bilirubin levels in up to 225 newborns.
Jaundice, a yellowing of the skin and eyes caused by a build up of bilirubin in the blood, is
      a common problem in newborn infants. Measurement of total serum bilirubin (TSB) levels is
      used for clinical decision making. BiliCam is a non-invasive technology used to estimate TSB
      levels in newborns. With BiliCam, the user obtains digital images of a small portion of a
      newborn's skin using the BiliCam app installed on a commercial smartphone in a standardized
      manner. A color calibration card is placed on the baby's sternum to account for varying light
      conditions. Data on color levels in the photos are used to estimate a bilirubin level.

      For the study, paired BiliCam estimated bilirubin (BCB) and TSB levels will be compared on a
      racially and ethnically diverse sample of newborns. Recruitment will continue until 225
      newborns have completed the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: BCB - TSB Correlation
time frame: Newborns up to 192 hours old
description: Pearson correlation coefficient between paired BCB- TSB measurements
measure: Intercept of Regression Line
time frame: Newborns up to 192 hours old
description: The intercept of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).
measure: Slope of Regression Line
time frame: Newborns up to 192 hours old
description: The slope of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).
arm group label: Newborns
arm group type: Experimental
description: Newborns will be enrolled in the study in 2 different ways. At "Staged Enrollment" sites, newborns will be enrolled when they are < 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At "Simultaneous Enrollment" sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.
intervention type: Device
intervention name: BiliCam estimated bilirubin (BCB)
description: Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care
arm group label: Newborns
criteria: 
gender: All
minimum age: 0 Hours
maximum age: 191 Hours
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Jaundice, Neonatal
mesh term: Jaundice
mesh term: Bilirubin
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 