NCT03280082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

June 25, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

September 7, 2017

Last Update Submit

February 9, 2021

Conditions

Malnutrition

Outcome Measures

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;

    18 months

Secondary Outcomes (2)

  • Readmission risks

    3 months

  • Deaths

    18 months

Other Outcomes (1)

  • Documentation of the results

    18 months

Study Arms (2)

MUAC Program

OTHER

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

Standard Program

OTHER

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

MUAC ProgramOTHER

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.

MUAC Program
Standard ProgramOTHER

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.

Standard Program

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRENAS

Madaoua, Niger

Location

Related Publications (1)

  • 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.

    PMID: 29970172DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Rebecca GRAIS, PhD

    Epicentre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 12, 2017

Study Start

June 25, 2018

Primary Completion

February 28, 2019

Study Completion

December 31, 2020

Last Updated

February 10, 2021

Record last verified: 2021-02

Locations

NI(1)