<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/NCT03007563</url>
  </required_header>
  <id_info>
    <org_study_id>2014/619</org_study_id>
    <nct_id>NCT03007563</nct_id>
  </id_info>
  <brief_title>Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice</brief_title>
  <official_title>Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Akershus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Olavs Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Neonatal jaundice is a common and most often harmless condition. However, when unrecognized&#xD;
      it can be fatal or cause serious brain injury. Three quarters of these deaths are estimated&#xD;
      to occur in the poorest regions of the world. The treatment of jaundice, phototherapy, is in&#xD;
      most cases easy, low-cost and harmless. The crucial point in reducing the burden of disease&#xD;
      is therefore to identify then children at risk. This results in the need for low-cost,&#xD;
      reliable and easy-to-use diagnostic tools that can identify newborns with jaundice.&#xD;
&#xD;
      Based on previous research on the bio-optics of jaundiced newborn skin, a prototype of a&#xD;
      smartphone application has been developed. This prototype will be evaluated in a clinical&#xD;
      trial in two hospitals in Norway. A smartphone will be used to take picture of the skin of&#xD;
      the newborn, and by using an algorithm an estimate of the bilirubin concentration is made.&#xD;
      The results from these estimates will be compared to the bilirubin levels measured in&#xD;
      standard blood samples, as well as the results from ordinary transcutaneous measurement&#xD;
      devices.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">March 15, 2019</completion_date>
  <primary_completion_date type="Actual">March 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between bilirubin estimates by smartphone pictures and by blood samples</measure>
    <time_frame>5 minutes</time_frame>
    <description>Estimate of bilirubin levels from smartphone pictures, compared with bilirubin measurement in blood samples in a correlation study. Correlation will be expressed by Pearson correlation coefficient, r.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between bilirubin estimates by smartphone pictures and by transcutaneous measurements</measure>
    <time_frame>5 minutes</time_frame>
    <description>Estimate of bilirubin levels from smartphone pictures, compared with bilirubin measurements from transcutaneous devices in a correlation study. Correlation will be expressed by Pearson correlation coefficient, r.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">342</enrollment>
  <condition>Jaundice, Neonatal</condition>
  <condition>Hyperbilirubinemia, Neonatal</condition>
  <arm_group>
    <arm_group_label>newborn infants checked for jaundice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>an experimental way of bilirubin concentration estimation from smartphone pictures is applied and compared with two standard methods: bilirubin concentration measured in standard blood samples, and bilirubin concentration measured by transcutaneous device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>bilirubin concentration estimation from smartphone pictures</intervention_name>
    <description>pictures taken of the skin covering the breast bone</description>
    <arm_group_label>newborn infants checked for jaundice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>bilirubin concentration measured in standard blood samples</intervention_name>
    <arm_group_label>newborn infants checked for jaundice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>bilirubin concentration measured by transcutaneous device</intervention_name>
    <arm_group_label>newborn infants checked for jaundice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  born in St.Olavs hospital, Trondheim or in Akershus hospital, Oslo, Norway&#xD;
&#xD;
          -  born at term&#xD;
&#xD;
          -  normal birth weight&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  in need of advanced medical treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>14 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Siri Forsmo, md prof</last_name>
    <role>Study Director</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Akershus University Hospital</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <results_reference>
    <citation>Aune A, Vartdal G, Bergseng H, Randeberg LL, Darj E. Bilirubin estimates from smartphone images of newborn infants' skin correlated highly to serum bilirubin levels. Acta Paediatr. 2020 Dec;109(12):2532-2538. doi: 10.1111/apa.15287. Epub 2020 Apr 19.</citation>
    <PMID>32267569</PMID>
  </results_reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>April 9, 2020</last_update_submitted>
  <last_update_submitted_qc>April 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diagnosis</keyword>
  <keyword>Cell Phones</keyword>
  <keyword>Infant, Newborn</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Jaundice, Neonatal</mesh_term>
    <mesh_term>Hyperbilirubinemia, Neonatal</mesh_term>
    <mesh_term>Jaundice</mesh_term>
    <mesh_term>Hyperbilirubinemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bilirubin</mesh_term>
  </intervention_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/NCT03007563
org study id: 2014/619
nct id: NCT03007563
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Neonatal jaundice is a common and most often harmless condition. However, when unrecognized
      it can be fatal or cause serious brain injury. Three quarters of these deaths are estimated
      to occur in the poorest regions of the world. The treatment of jaundice, phototherapy, is in
      most cases easy, low-cost and harmless. The crucial point in reducing the burden of disease
      is therefore to identify then children at risk. This results in the need for low-cost,
      reliable and easy-to-use diagnostic tools that can identify newborns with jaundice.

      Based on previous research on the bio-optics of jaundiced newborn skin, a prototype of a
      smartphone application has been developed. This prototype will be evaluated in a clinical
      trial in two hospitals in Norway. A smartphone will be used to take picture of the skin of
      the newborn, and by using an algorithm an estimate of the bilirubin concentration is made.
      The results from these estimates will be compared to the bilirubin levels measured in
      standard blood samples, as well as the results from ordinary transcutaneous measurement
      devices.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Correlation between bilirubin estimates by smartphone pictures and by blood samples
time frame: 5 minutes
description: Estimate of bilirubin levels from smartphone pictures, compared with bilirubin measurement in blood samples in a correlation study. Correlation will be expressed by Pearson correlation coefficient, r.
measure: Correlation between bilirubin estimates by smartphone pictures and by transcutaneous measurements
time frame: 5 minutes
description: Estimate of bilirubin levels from smartphone pictures, compared with bilirubin measurements from transcutaneous devices in a correlation study. Correlation will be expressed by Pearson correlation coefficient, r.
arm group label: newborn infants checked for jaundice
arm group type: Experimental
description: an experimental way of bilirubin concentration estimation from smartphone pictures is applied and compared with two standard methods: bilirubin concentration measured in standard blood samples, and bilirubin concentration measured by transcutaneous device.
intervention type: Device
intervention name: bilirubin concentration estimation from smartphone pictures
description: pictures taken of the skin covering the breast bone
arm group label: newborn infants checked for jaundice
intervention type: Procedure
intervention name: bilirubin concentration measured in standard blood samples
arm group label: newborn infants checked for jaundice
intervention type: Device
intervention name: bilirubin concentration measured by transcutaneous device
arm group label: newborn infants checked for jaundice
criteria: 
gender: All
minimum age: 1 Day
maximum age: 14 Days
healthy volunteers: No
last name: Siri Forsmo, md prof
role: Study Director
affiliation: Norwegian University of Science and Technology
facility: 
facility: 
country: Norway
citation: Aune A, Vartdal G, Bergseng H, Randeberg LL, Darj E. Bilirubin estimates from smartphone images of newborn infants' skin correlated highly to serum bilirubin levels. Acta Paediatr. 2020 Dec;109(12):2532-2538. doi: 10.1111/apa.15287. Epub 2020 Apr 19.
PMID: 32267569
responsible party type: Sponsor
mesh term: Jaundice, Neonatal
mesh term: Hyperbilirubinemia, Neonatal
mesh term: Jaundice
mesh term: Hyperbilirubinemia
mesh term: Bilirubin
sharing ipd: No