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

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Niger
Study Type
Interventional
Intervention
MUAC Program
Standard Program
Sponsored by
Epicentre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • CRENAS

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

MUAC Program

Standard Program

Arm Description

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

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

Outcomes

Primary Outcome Measures

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;

Secondary Outcome Measures

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
Deaths
Compare the death rate between the two groups

Full Information

First Posted
September 7, 2017
Last Updated
February 9, 2021
Sponsor
Epicentre
Collaborators
Medecins Sans Frontieres, Spain, Direction de la Nutrition du Niger, District Sanitaire de Madaoua, Niger, Direction Régionale Sanitaire de Tahoua, Niger
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1. Study Identification

Unique Protocol Identification Number
NCT03280082
Brief Title
Use of MUAC as Basic Criterion for Admission, Follow-up and Exit From the Ambulatory Nutrition Program
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 25, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Epicentre
Collaborators
Medecins Sans Frontieres, Spain, Direction de la Nutrition du Niger, District Sanitaire de Madaoua, Niger, Direction Régionale Sanitaire de Tahoua, Niger

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MUAC Program
Arm Type
Other
Arm Description
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
Arm Title
Standard Program
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
MUAC Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Program
Intervention Description
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 Measure Information:
Title
Nutritional recovery
Description
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 Outcome Measure Information:
Title
Readmission risks
Description
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
Title
Deaths
Description
Compare the death rate between the two groups
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
Documentation of the results
Description
Document coverage of the nutrition program before and after the implementation of the
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca GRAIS, PhD
Organizational Affiliation
Epicentre
Official's Role
Study Director
Facility Information:
Facility Name
CRENAS
City
Madaoua
Country
Niger

12. IPD Sharing Statement

Citations:
PubMed Identifier
29970172
Citation
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.
Results Reference
derived

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

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