<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/NCT03303131</url>
  </required_header>
  <id_info>
    <org_study_id>MUAC 2007-2011</org_study_id>
    <nct_id>NCT03303131</nct_id>
  </id_info>
  <brief_title>SAM: Discharge Based on the Use of a MUAC-based Criterion to</brief_title>
  <official_title>Discharge From Community-based Management of Severe Acute Malnutrition Using Mid Upper Arm Circumference</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Epicentre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medecins Sans Frontieres, Netherlands</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Epicentre</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>
      Retrospective analysis of routine program data of children aged 6 to 59 months admitted to&#xD;
      the MSF therapeutic feeding program with MUAC ≤ 118 mm in Yako and Titao districts of Burkina&#xD;
      Faso from 2007-2011.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Comparison of patient characteristics and treatment outcomes was conducted between two&#xD;
      groups: 1) children discharged as recovered from September 2007 to March 2009 with at least&#xD;
      15% of their weight at admission (Period A); and 2) children discharged as recovered from&#xD;
      April 2009 to December 2011 with MUAC ≥ 124 mm (Period B).&#xD;
&#xD;
      A total of 50,841 children were admitted with MUAC ≤ 118 mm to the MSF therapeutic feeding&#xD;
      program and were included in this analysis: 24,792 children in Period A (2007-2009) and&#xD;
      26,049 children in Period B (2009-2011).&#xD;
&#xD;
      Overall, 89% of admissions were directly into outpatient care and the majority (53%) entered&#xD;
      with a MUAC 116-118mm; 48% of children were male and 80% of children &lt; 2 years of age (Table&#xD;
      1).&#xD;
&#xD;
      Compared to children admitted in Period A, children admitted in Period B were statistically&#xD;
      more likely to be female, younger, and of better anthropometric status (e.g. higher mean&#xD;
      MUAC, WHZ and HAZ).&#xD;
&#xD;
      There was a greater proportion of children admitted directly to inpatient care in Period B&#xD;
      than in Period A (10.6% vs 8.0%).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2007</start_date>
  <completion_date type="Actual">December 31, 2011</completion_date>
  <primary_completion_date type="Actual">December 31, 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MUAC based criterion</measure>
    <time_frame>52 months</time_frame>
    <description>Use of a discharge criterion of MUAC ≥ 124 mm</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50841</enrollment>
  <condition>Severe Acute Malnutrition</condition>
  <arm_group>
    <arm_group_label>Period A</arm_group_label>
    <description>Children discharged as recovered from September 2007 to March 2009 with at least 15% of their weight at admission</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Period B</arm_group_label>
    <description>Children discharged as recovered from April 2009 to December 2011 with Children discharged as recovered from September 2007-March 2009 with MUAC ≥ 124 mm</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Discharge from community-based management</intervention_name>
    <description>Comparison of patient characteristics and treatment outcomes between two groups</description>
    <arm_group_label>Period A</arm_group_label>
    <arm_group_label>Period B</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All children admitted to the MSF therapeutic feeding program in Yako and Titao districts&#xD;
        from September 2007 to December 2011&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  6 to 59 months old&#xD;
&#xD;
          -  presence of bipedal pitting edema or MUAC ≤ 118 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 6 months old or &gt; 59 months old&#xD;
&#xD;
          -  absence of bipedal pitting edema or MUAC ≥ 118 mm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>59 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>February 1, 2018</last_update_submitted>
  <last_update_submitted_qc>February 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 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>Malnutrition</mesh_term>
    <mesh_term>Severe Acute Malnutrition</mesh_term>
  </condition_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/NCT03303131
org study id: MUAC 2007-2011
nct id: NCT03303131
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Retrospective analysis of routine program data of children aged 6 to 59 months admitted to
      the MSF therapeutic feeding program with MUAC ≤ 118 mm in Yako and Titao districts of Burkina
      Faso from 2007-2011.
Comparison of patient characteristics and treatment outcomes was conducted between two
      groups: 1) children discharged as recovered from September 2007 to March 2009 with at least
      15% of their weight at admission (Period A); and 2) children discharged as recovered from
      April 2009 to December 2011 with MUAC ≥ 124 mm (Period B).

      A total of 50,841 children were admitted with MUAC ≤ 118 mm to the MSF therapeutic feeding
      program and were included in this analysis: 24,792 children in Period A (2007-2009) and
      26,049 children in Period B (2009-2011).

      Overall, 89% of admissions were directly into outpatient care and the majority (53%) entered
      with a MUAC 116-118mm; 48% of children were male and 80% of children < 2 years of age (Table
      1).

      Compared to children admitted in Period A, children admitted in Period B were statistically
      more likely to be female, younger, and of better anthropometric status (e.g. higher mean
      MUAC, WHZ and HAZ).

      There was a greater proportion of children admitted directly to inpatient care in Period B
      than in Period A (10.6% vs 8.0%).
observational model: Ecologic or Community
time perspective: Retrospective
measure: MUAC based criterion
time frame: 52 months
description: Use of a discharge criterion of MUAC ≥ 124 mm
arm group label: Period A
description: Children discharged as recovered from September 2007 to March 2009 with at least 15% of their weight at admission
arm group label: Period B
description: Children discharged as recovered from April 2009 to December 2011 with Children discharged as recovered from September 2007-March 2009 with MUAC ≥ 124 mm
intervention type: Other
intervention name: Discharge from community-based management
description: Comparison of patient characteristics and treatment outcomes between two groups
arm group label: Period A
arm group label: Period B
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: 59 Months
healthy volunteers: No
responsible party type: Sponsor
mesh term: Malnutrition
mesh term: Severe Acute Malnutrition
sharing ipd: No