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

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

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition
• Intervention / Treatment: Other: MUAC Program; Other: Standard Program

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.

• Study Type: Interventional
• Enrollment (Actual): 6200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Niger
  • Madaoua, Niger
    • CRENAS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional recovery	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;	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission risks	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	3 months
Deaths	Compare the death rate between the two groups	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Documentation of the results	Document coverage of the nutrition program before and after the implementation of the	18 months

Collaborators and Investigators

• Sponsor: Epicentre
• Collaborators: Medecins Sans Frontieres, Spain; Direction de la Nutrition du Niger; District Sanitaire de Madaoua, Niger; Direction Régionale Sanitaire de Tahoua, Niger
• Investigators: Study Director: Rebecca Grais, PhD, Epicentre

Publications and helpful links

General Publications

• Isanaka S, Hedt-Gauthier BL, Grais RF, Allen BGS. Estimating program coverage in the treatment of severe acute malnutrition: a comparative analysis of the validity and operational feasibility of two methods. Popul Health Metr. 2018 Jul 3;16(1):11. doi: 10.1186/s12963-018-0167-3.

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2018
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: MUAC 120

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No