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

Malnutrition Clinical Trial

— MUAC120  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03280082
• Other study ID #: MUAC 120
• Status: Completed
• Phase: N/A
• Start date: June 25, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Epicentre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6200
• Est. completion date: December 31, 2020
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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).

Related Conditions & MeSH terms

• Malnutrition

Intervention

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
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.

Locations

Country	Name	City	State
Niger	CRENAS	Madaoua

Sponsors (5)

Lead Sponsor	Collaborator
Epicentre	Direction de la Nutrition du Niger, Direction Régionale Sanitaire de Tahoua, Niger, District Sanitaire de Madaoua, Niger, Medecins Sans Frontieres, Spain

Country where clinical trial is conducted

Niger, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Documentation of the results	Document coverage of the nutrition program before and after the implementation of the	18 months
Primary	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	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
Secondary	Deaths	Compare the death rate between the two groups	18 months