<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/NCT03260413</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000091</org_study_id>
    <nct_id>NCT03260413</nct_id>
  </id_info>
  <brief_title>Pneumonia Chart Review Cambodia</brief_title>
  <official_title>Quantifying the Burden of Hospitalizations for Pneumonia Among Children in Rural</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</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>
      This study aims to answer the question of what is the burden of lower respiratory disease&#xD;
      (pneumonia) among children ages 1 month to 5 years of age in rural Cambodia. The primary&#xD;
      objective will be to quantify the prevalence of severe pneumonia at Chenla Children's&#xD;
      Healthcare, a hospital in the rural town of Kratie, Cambodia. This will involve a chart&#xD;
      review of the medical records available at Chenla Children's Healthcare.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Could not get IRB approval&#xD;
  </why_stopped>
  <start_date type="Anticipated">February 12, 2018</start_date>
  <completion_date type="Anticipated">March 9, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 9, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pneumonia count</measure>
    <time_frame>5-6 months</time_frame>
    <description>Number of admissions for pneumonia to Chenla Children's healthcare</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Pneumonia</condition>
  <arm_group>
    <arm_group_label>Pneumonia cases</arm_group_label>
    <description>Children between the ages of 1 month through 5 years of age who are admitted to Chenla Children's Healthcare between opening of the hospital (mid-2017) and early February 2018 for pneumonia and respiratory distress.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will be children between the ages of 1 month and 5 years who were&#xD;
        admitted to Chenla Children's Healthcare with at least one admitting diagnosis being&#xD;
        &quot;pneumonia&quot; or &quot;bronchiolitis&quot;. These children will be residents of Kratie province,&#xD;
        Cambodia. They are admitted to Chenla Children's Healthcare by way of their emergency&#xD;
        department.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children between the ages of 1 month and 5 years admitted to Chenla Children's&#xD;
             Healthcare with at least one admitting diagnosis being pneumonia or bronchiolitis will&#xD;
             be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who do not fall into the aforementioned age range and who do not have&#xD;
             &quot;pneumonia&quot; or &quot;bronchiolitis&quot; as one of the admitted diagnoses.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>March 23, 2018</last_update_submitted>
  <last_update_submitted_qc>March 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2018</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>Pneumonia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data from this chart review will be used to inform baseline information of a larger study that is currently in the planning stages. All investigators participating in this chart review are also investigators in this larger study. Information from this chart review will only be accessed by investigators participating in this larger study and by no one outside of this larger study.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>The data will become available by March 10, 2018. It will be available for 4 years.</ipd_time_frame>
  </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/NCT03260413
org study id: STUDY00000091
nct id: NCT03260413
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to answer the question of what is the burden of lower respiratory disease
      (pneumonia) among children ages 1 month to 5 years of age in rural Cambodia. The primary
      objective will be to quantify the prevalence of severe pneumonia at Chenla Children's
      Healthcare, a hospital in the rural town of Kratie, Cambodia. This will involve a chart
      review of the medical records available at Chenla Children's Healthcare.
observational model: Case-Only
time perspective: Retrospective
measure: Pneumonia count
time frame: 5-6 months
description: Number of admissions for pneumonia to Chenla Children's healthcare
arm group label: Pneumonia cases
description: Children between the ages of 1 month through 5 years of age who are admitted to Chenla Children's Healthcare between opening of the hospital (mid-2017) and early February 2018 for pneumonia and respiratory distress.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 5 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Pneumonia
sharing ipd: Yes
ipd description: The data from this chart review will be used to inform baseline information of a larger study that is currently in the planning stages. All investigators participating in this chart review are also investigators in this larger study. Information from this chart review will only be accessed by investigators participating in this larger study and by no one outside of this larger study.
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: The data will become available by March 10, 2018. It will be available for 4 years.