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CompletedNCT03280082MUAC120Updated Feb 10, 2021

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

An interventional study of MUAC Program and Standard Program in Malnutrition, sponsored by Epicentre. Completed at 1 site in Niger. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2021-02-10.

Sponsored by Epicentre · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
6,200
Allocation
Non-randomized
Ages
6 Months to 59 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Malnutrition

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03

Who can participate

Ages eligible
6 Months to 59 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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).
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
6,200 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherMUAC 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.

  • OtherStandard 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.

05

What researchers measure

Primary outcomes

  1. 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;

    Time frame: 18 months

Secondary outcomes

  1. 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

    Time frame: 3 months

  2. Deaths

    Compare the death rate between the two groups

    Time frame: 18 months

Other outcomes

  1. Documentation of the results

    Document coverage of the nutrition program before and after the implementation of the

    Time frame: 18 months

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Study locations

1 site
  • CRENAS
    Madaoua, Niger
07

References and documents

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. PubMed 29970172 ↗
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Registry details

Key details

Study ID
NCT03280082
Lead sponsor
Epicentre
Collaborators
Medecins Sans Frontieres, Spain, Direction de la Nutrition du Niger, District Sanitaire de Madaoua, Niger, Direction Régionale Sanitaire de Tahoua, Niger
Responsible party
Sponsor
First posted
Sep 12, 2017
Start date
Jun 25, 2018
Primary completion
Feb 28, 2019
Completion
Dec 31, 2020
Last update
Feb 10, 2021

Study contacts

Rebecca GRAIS, PhD
study director · Epicentre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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