<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/NCT03280082</url>
  </required_header>
  <id_info>
    <org_study_id>MUAC 120</org_study_id>
    <nct_id>NCT03280082</nct_id>
  </id_info>
  <brief_title>Use of MUAC as Basic Criterion for Admission, Follow-up and Exit From the Ambulatory Nutrition Program</brief_title>
  <acronym>MUAC120</acronym>
  <official_title>Operational Experience for the Use of the Mid-Upper Arm Circumference (MUAC) as the Basic Criterion for Admission, Follow-up and Exit of the Ambulatory Nutrition Program in Two CRENAS, Madaoua District, Niger</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Epicentre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medecins Sans Frontieres, Spain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Direction de la Nutrition du Niger</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>District Sanitaire de Madaoua, Niger</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Direction Régionale Sanitaire de Tahoua, Niger</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>
      The aim of this study is to provide comprehensive documentation of the relevant results and&#xD;
      operational implications of this new model using Mid-Upper Arm Circumference (MUAC) as the&#xD;
      single anthropometric criterion for admission, monitoring and exit of non- complicated in&#xD;
      Niger.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a first operational experiment using Mid-Upper Arm Circumference (MUAC) as the single&#xD;
      anthropometric criterion for the admission, monitoring and exit of the management of&#xD;
      uncomplicated SAM (Severe Acute Malnutrition) in Niger, specific data as well as data from&#xD;
      routine program will be collected to allow comprehensive documentation of all relevant&#xD;
      results and operational implications of this new model. The experiment based on the use of&#xD;
      the single anthropometric threshold for admission of a Mid-Upper Arm Circumference (MUAC)&lt;120&#xD;
      mm, which includes both children currently classified as having SAM (currently with PB &lt;115&#xD;
      mm) and acute malnutrition moderate (MAM, currently with a Mid-Upper Arm Circumference&#xD;
      (MUAC)&lt;125 mm), as well as a follow-up of children with a Mid-Upper Arm Circumference (MUAC)≥&#xD;
      120 mm, will identify how children respond to treatment and benefit of the spectrum of acute&#xD;
      malnutrition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2018</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nutritional recovery</measure>
    <time_frame>18 months</time_frame>
    <description>Compare the average daily weight gain and the duration of the nutritional treatment per group compare the results of the PB programme, including the overall risk of recovery, transfer, of abandonment, of death, of PB and weight gain and the length of stay by age (6-23 months, compared to 24-59 months), compared the results of the program standard;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Readmission risks</measure>
    <time_frame>3 months</time_frame>
    <description>Assessment of the risk of readmission 3 months after discharged of the child will be evaluated at 3 months (+/- one week) after discharged of the child</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deaths</measure>
    <time_frame>18 months</time_frame>
    <description>Compare the death rate between the two groups</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Documentation of the results</measure>
    <time_frame>18 months</time_frame>
    <description>Document coverage of the nutrition program before and after the implementation of the</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6200</enrollment>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>MUAC Program</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>At the CRENAS, MUAC as unique anthropometric criteria for admission, monitoring, and care for the SAM output will be used.&#xD;
The criteria for admission include:&#xD;
MUAC &lt;120 mm&#xD;
Bilateral edema of grade + or ++&#xD;
The criteria for release of care include:&#xD;
MUAC ≥ 125 mm at 2 consecutive visits&#xD;
Minimum stay 3 weeks in the program&#xD;
Absence of acute medical complications&#xD;
Absence of edema</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Program</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Regular screenings in the communities on children between 6 and 59 months of age. Children with MUAC&lt;125 mm will be referred to Nutrition Centers for admission.&#xD;
The criteria for admission include:&#xD;
MUAC&lt;115 mm and/or&#xD;
Z score &lt;-3 and /or&#xD;
Bilateral edema of grade + or ++&#xD;
The criteria for release of care include:&#xD;
MUAC ≥ 125 mm at 2 consecutive visits&#xD;
Minimum stay 3 weeks in the program&#xD;
Absence of acute medical complications&#xD;
Absence of edema</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MUAC Program</intervention_name>
    <description>All children admitted to the PB program will receive standard care according to the national Protocol and that of MSF, including preventive and therapeutic care at admission as well as hospital care in case of clinical complications. There will be no change in the Protocol for the hospital care to the CRENI (Center of Intensive Nutritional Rehabilitation). RUTF (Ready-to-Use therapeutic food) will be distributed on a weekly basis according to the dosage of RUTF in the national protocol.</description>
    <arm_group_label>MUAC Program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Program</intervention_name>
    <description>All children admitted to the standard program will receive standard care according to national and MSF protocols, including preventive and therapeutic care on admission as well as hospital care in case of clinical complications. RUTF will be distributed on a weekly basis according to the dosage of RUTF in the national protocol.</description>
    <arm_group_label>Standard Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All children admitted for non-complicated SAM (Severe Acute Malnutrition) treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children between the ages of 6 and 59 months who were recently excluded from treatment&#xD;
             by admission criteria based on MUAC (Sabon Guida site) but were previously eligible&#xD;
             for treatment (ie MUAC ≥ 120 and Z score &lt;-3).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>59 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rebecca GRAIS, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Epicentre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CRENAS</name>
      <address>
        <city>Madaoua</city>
        <country>Niger</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Niger</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>February 9, 2021</last_update_submitted>
  <last_update_submitted_qc>February 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2021</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>
  </condition_browse>
  <!-- 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/NCT03280082
org study id: MUAC 120
nct id: NCT03280082
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to provide comprehensive documentation of the relevant results and
      operational implications of this new model using Mid-Upper Arm Circumference (MUAC) as the
      single anthropometric criterion for admission, monitoring and exit of non- complicated in
      Niger.
This is a first operational experiment using Mid-Upper Arm Circumference (MUAC) as the single
      anthropometric criterion for the admission, monitoring and exit of the management of
      uncomplicated SAM (Severe Acute Malnutrition) in Niger, specific data as well as data from
      routine program will be collected to allow comprehensive documentation of all relevant
      results and operational implications of this new model. The experiment based on the use of
      the single anthropometric threshold for admission of a Mid-Upper Arm Circumference (MUAC)<120
      mm, which includes both children currently classified as having SAM (currently with PB <115
      mm) and acute malnutrition moderate (MAM, currently with a Mid-Upper Arm Circumference
      (MUAC)<125 mm), as well as a follow-up of children with a Mid-Upper Arm Circumference (MUAC)≥
      120 mm, will identify how children respond to treatment and benefit of the spectrum of acute
      malnutrition.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Nutritional recovery
time frame: 18 months
description: Compare the average daily weight gain and the duration of the nutritional treatment per group compare the results of the PB programme, including the overall risk of recovery, transfer, of abandonment, of death, of PB and weight gain and the length of stay by age (6-23 months, compared to 24-59 months), compared the results of the program standard;
measure: Readmission risks
time frame: 3 months
description: Assessment of the risk of readmission 3 months after discharged of the child will be evaluated at 3 months (+/- one week) after discharged of the child
measure: Deaths
time frame: 18 months
description: Compare the death rate between the two groups
measure: Documentation of the results
time frame: 18 months
description: Document coverage of the nutrition program before and after the implementation of the
arm group label: MUAC Program
arm group type: Other
description: At the CRENAS, MUAC as unique anthropometric criteria for admission, monitoring, and care for the SAM output will be used.
The criteria for admission include:
MUAC <120 mm
Bilateral edema of grade + or ++
The criteria for release of care include:
MUAC ≥ 125 mm at 2 consecutive visits
Minimum stay 3 weeks in the program
Absence of acute medical complications
Absence of edema
arm group label: Standard Program
arm group type: Other
description: Regular screenings in the communities on children between 6 and 59 months of age. Children with MUAC<125 mm will be referred to Nutrition Centers for admission.
The criteria for admission include:
MUAC<115 mm and/or
Z score <-3 and /or
Bilateral edema of grade + or ++
The criteria for release of care include:
MUAC ≥ 125 mm at 2 consecutive visits
Minimum stay 3 weeks in the program
Absence of acute medical complications
Absence of edema
intervention type: Other
intervention name: MUAC Program
description: All children admitted to the PB program will receive standard care according to the national Protocol and that of MSF, including preventive and therapeutic care at admission as well as hospital care in case of clinical complications. There will be no change in the Protocol for the hospital care to the CRENI (Center of Intensive Nutritional Rehabilitation). RUTF (Ready-to-Use therapeutic food) will be distributed on a weekly basis according to the dosage of RUTF in the national protocol.
arm group label: MUAC Program
intervention type: Other
intervention name: Standard Program
description: All children admitted to the standard program will receive standard care according to national and MSF protocols, including preventive and therapeutic care on admission as well as hospital care in case of clinical complications. RUTF will be distributed on a weekly basis according to the dosage of RUTF in the national protocol.
arm group label: Standard Program
criteria: 
gender: All
minimum age: 6 Months
maximum age: 59 Months
healthy volunteers: No
last name: Rebecca GRAIS, PhD
role: Study Director
affiliation: Epicentre
facility: 
country: Niger
responsible party type: Sponsor
mesh term: Malnutrition