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Use of MUAC as Basic Criterion for Admission, Follow-up and Exit From the Ambulatory Nutrition Program (MUAC120)

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ClinicalTrials.gov Identifier: NCT03280082
Recruitment Status : Active, not recruiting
First Posted : September 12, 2017
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
Medecins Sans Frontieres, Spain
Direction de la Nutrition du Niger
District Sanitaire de Madaoua, Niger
Direction Régionale Sanitaire de Tahoua, Niger
Information provided by (Responsible Party):
Epicentre

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malnutrition Other: MUAC Program Other: Standard Program Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 25, 2018
Actual Primary Completion Date : February 28, 2019
Estimated Study Completion Date : August 30, 2019

Arm Intervention/treatment
MUAC Program

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
Other: MUAC Program
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.

Standard Program

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
Other: Standard Program
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.




Primary Outcome Measures :
  1. Nutritional recovery [ Time Frame: 18 months ]
    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;


Secondary Outcome Measures :
  1. Readmission risks [ Time Frame: 3 months ]
    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

  2. Deaths [ Time Frame: 18 months ]
    Compare the death rate between the two groups


Other Outcome Measures:
  1. Documentation of the results [ Time Frame: 18 months ]
    Document coverage of the nutrition program before and after the implementation of the



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All children admitted for non-complicated SAM (Severe Acute Malnutrition) treatment

Exclusion Criteria:

  • Children between the ages of 6 and 59 months who were recently excluded from treatment by admission criteria based on MUAC (Sabon Guida site) but were previously eligible for treatment (ie MUAC ≥ 120 and Z score <-3).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280082


Locations
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Niger
CRENAS
Madaoua, Niger
Sponsors and Collaborators
Epicentre
Medecins Sans Frontieres, Spain
Direction de la Nutrition du Niger
District Sanitaire de Madaoua, Niger
Direction Régionale Sanitaire de Tahoua, Niger
Investigators
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Study Director: Rebecca GRAIS, PhD Epicentre

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Epicentre
ClinicalTrials.gov Identifier: NCT03280082     History of Changes
Other Study ID Numbers: MUAC 120
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders