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Completed

NCT Number: NCT03280082

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

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.

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Key information

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CRENAS

Madaoua, Niger

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

MUAC Program

Other

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

Other

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 outcomes

  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 outcomes

  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 outcomes

  1. Documentation of the results

    Time frame: 18 months

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

Sponsors and collaborators

Lead sponsor

Epicentre

Other

Collaborators

  • Direction Régionale Sanitaire de Tahoua, Niger
  • Direction de la Nutrition du Niger
  • District Sanitaire de Madaoua, Niger
  • Medecins Sans Frontieres, Spain

Registry information

Official study 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

Acronym: MUAC120

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 12, 2017
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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