<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/NCT01687621</url>
  </required_header>
  <id_info>
    <org_study_id>OCAVS</org_study_id>
    <nct_id>NCT01687621</nct_id>
  </id_info>
  <brief_title>Omphalitis Community Based Algorithm Validation Study</brief_title>
  <acronym>OCAVS</acronym>
  <official_title>Omphalitis Community Based Algorithm Validation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bill and Melinda Gates Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Thrasher Research Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to develop and test a simple community-based diagnostic&#xD;
      algorithm for omphalitis in sub-Saharan Africa. To date, there has been no validated&#xD;
      community-based algorithms developed and tested in the sub-Saharan context where the&#xD;
      manifestations of omphalitis presentation may vary and diagnosis could be potentially more&#xD;
      challenging in infants with darker skin color. Given the current attention to cord care at&#xD;
      the global and national policy level, validated community-based algorithms will be needed to&#xD;
      allow primary health workers to identify cord infections and reduce associated morbidity.&#xD;
&#xD;
      After obtaining guardian informed consent, newborns aged 1-10 days presenting to the health&#xD;
      facility for routine or sick visits will undergo two independent, parallel evaluations;&#xD;
      first, by a community level worker and second, by a Zambian medical doctor (gold standard). A&#xD;
      third independent assessment of a photo of the cord will be performed remotely by a&#xD;
      board-certified pediatrician. Using the on-site clinician as the gold standard, the&#xD;
      community-based algorithm and the photo assessment will be tested for concordance and the&#xD;
      sensitivity and specificity of the algorithm will be generated. Likewise, the remote&#xD;
      pictorial assessment will be compared to the gold standard to determine reliability of&#xD;
      diagnosis from photographs alone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</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>Validity of the omphalitis algorithm</measure>
    <time_frame>10 months</time_frame>
    <description>The primary outcome of the study is a measure of validity (concordance) of the the omphalitis algorithm generated by inter-observer kappa statistics to evaluate diagnostic concordance between the field monitors and the gold standard cord health expert on specific algorithmic questions. Questions that demonstrate high concordance will be selected for inclusion in the final algorithm. Sensitivity and specificity of the final algorithm will be generated.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1009</enrollment>
  <condition>Omphalitis</condition>
  <arm_group>
    <arm_group_label>Neonates, 1 to 10 days old</arm_group_label>
    <description>Neonates between day 1-10 of life presenting to hospitals and community health centers in Southern Province, Zambia, with no prior diagnosis of omphalitis, whose guardian, aged 15 and above, is willing to allow their newborn to participate in the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Diagnostic Algorithm for Community Based Worker for Omphalitis</intervention_name>
    <description>After obtaining guardian informed written consent, newborns aged 1-10 days presenting to the health facility for routine or sick visits would undergo 2 independent, parallel evaluations; first, by a ZamCAT Field Monitor (community level worker from our existing study) and the second by a Zambian medical doctor (gold standard). A US board of pediatrics-certified pediatrician will perform a third independent assessment of a photo of the cord remotely. Using the on-site clinician as the gold standard, the community-based algorithm and the photo assessment will be tested for concordance and the sensitivity and specificity of the algorithm will be generated. Likewise, the remote pictorial assessment will be compared to the gold standard to determine reliability of diagnosis from photographs alone.</description>
    <arm_group_label>Neonates, 1 to 10 days old</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Neonate between day 1-10 of life presenting to Livingstone and Mazabuka district hospitals&#xD;
        and community health centers in Southern Province, Zambia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neonate between day 1-10 of life presenting to Livingstone and Mazabuka district&#xD;
             hospitals and community health centers in Southern Province, Zambia&#xD;
&#xD;
          -  No prior diagnosis of omphalitis&#xD;
&#xD;
          -  Guardian willing to allow their newborn to participate in the study&#xD;
&#xD;
          -  Guardian aged 15 and above&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>10 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julie M Herlihy, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospitals &amp; Community Health Centers</name>
      <address>
        <city>Livingstone</city>
        <state>Southern Province</state>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Zambia</country>
  </location_countries>
  <link>
    <url>http://www.bu.edu/cghd/our-work/projects/zambia-chlorhexidrine-application-trial-zamcat/</url>
    <description>Zambia Chlorhexidine Application Trial</description>
  </link>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>July 20, 2015</last_update_submitted>
  <last_update_submitted_qc>July 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston University</investigator_affiliation>
    <investigator_full_name>Julie M Herlihy</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Omphalitis</keyword>
  <keyword>Neonate</keyword>
  <keyword>Zambia</keyword>
  <keyword>Neonatal mortality</keyword>
  <keyword>Umbilical cord infection</keyword>
  <!-- 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/NCT01687621
org study id: OCAVS
nct id: NCT01687621
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The objective of this study is to develop and test a simple community-based diagnostic
      algorithm for omphalitis in sub-Saharan Africa. To date, there has been no validated
      community-based algorithms developed and tested in the sub-Saharan context where the
      manifestations of omphalitis presentation may vary and diagnosis could be potentially more
      challenging in infants with darker skin color. Given the current attention to cord care at
      the global and national policy level, validated community-based algorithms will be needed to
      allow primary health workers to identify cord infections and reduce associated morbidity.

      After obtaining guardian informed consent, newborns aged 1-10 days presenting to the health
      facility for routine or sick visits will undergo two independent, parallel evaluations;
      first, by a community level worker and second, by a Zambian medical doctor (gold standard). A
      third independent assessment of a photo of the cord will be performed remotely by a
      board-certified pediatrician. Using the on-site clinician as the gold standard, the
      community-based algorithm and the photo assessment will be tested for concordance and the
      sensitivity and specificity of the algorithm will be generated. Likewise, the remote
      pictorial assessment will be compared to the gold standard to determine reliability of
      diagnosis from photographs alone.
observational model: Cohort
time perspective: Prospective
measure: Validity of the omphalitis algorithm
time frame: 10 months
description: The primary outcome of the study is a measure of validity (concordance) of the the omphalitis algorithm generated by inter-observer kappa statistics to evaluate diagnostic concordance between the field monitors and the gold standard cord health expert on specific algorithmic questions. Questions that demonstrate high concordance will be selected for inclusion in the final algorithm. Sensitivity and specificity of the final algorithm will be generated.
arm group label: Neonates, 1 to 10 days old
description: Neonates between day 1-10 of life presenting to hospitals and community health centers in Southern Province, Zambia, with no prior diagnosis of omphalitis, whose guardian, aged 15 and above, is willing to allow their newborn to participate in the study.
intervention type: Procedure
intervention name: Diagnostic Algorithm for Community Based Worker for Omphalitis
description: After obtaining guardian informed written consent, newborns aged 1-10 days presenting to the health facility for routine or sick visits would undergo 2 independent, parallel evaluations; first, by a ZamCAT Field Monitor (community level worker from our existing study) and the second by a Zambian medical doctor (gold standard). A US board of pediatrics-certified pediatrician will perform a third independent assessment of a photo of the cord remotely. Using the on-site clinician as the gold standard, the community-based algorithm and the photo assessment will be tested for concordance and the sensitivity and specificity of the algorithm will be generated. Likewise, the remote pictorial assessment will be compared to the gold standard to determine reliability of diagnosis from photographs alone.
arm group label: Neonates, 1 to 10 days old
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 10 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Julie M Herlihy, MD MPH
role: Principal Investigator
affiliation: Boston University
facility: 
country: Zambia
url: http://www.bu.edu/cghd/our-work/projects/zambia-chlorhexidrine-application-trial-zamcat/
description: Zambia Chlorhexidine Application Trial
responsible party type: Principal Investigator
investigator affiliation: Boston University
investigator full name: Julie M Herlihy
investigator title: Assistant Professor