Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Burkina Faso (MUAC-Only)

January 29, 2019 updated by: Alliance for International Medical Action

Effectiveness of an Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Passore Province (Northern Region), Burkina Faso

MUAC only is a pilot trial external control carried out between January 2017 and December 2017 in the Yako district (northern region), Burkina Faso.

The objective of this study is to evaluate an integrated protocol for acute malnourished children without medical complication. The hypotheses of the integrated protocol include :

  1. A global treatment of acute malnutrition (moderate and severe) with a single treatment (RUTF) would improve the functioning of the program through early identification of acutely malnourished children, while achieving a better coverage and using a single supply chain.
  2. A gradual reduction of RUTF dosage according to a child's MUAC status could significantly increase the number of children on treatment without increasing overall RUTF quantity while maintaining similar recovery rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives :

Main objective :

To ensure the recovery rate of the integrated protocol for treatment of acute malnutrition is significantly greater than 75% (reference value of the national program in BF).

Secondary objectives :

  • To ensure the mortality rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 3% (reference value of the national BF program).
  • To ensure the default rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 15% (reference value of the national BF program).
  • To ensure the non-response rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 8%.
  • To ensure the hospitalization rate of the integrated protocol for treatment of acute malnutrition is significantly lower than 15%.
  • To ensure the coverage rate of the program increases by 30% after the year the integrated protocol was introduced (specific protocol annexed).
  • To estimate the relapse rate of the integrated protocol for treatment of acute malnutrition.
  • To compare RUTF rations per child of the integrated protocol compared to the national protocol

Methods :

The study population will include all acutely malnourished children aged between 6 and 59 months seeking consultations at all of the health centers in Yako District between January 2017 and December 2017.

The study will be implemented in Burkina Faso's Yako District, which includes 54 health centers.

Study Type

Interventional

Enrollment (Actual)

4958

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
    • Region Nord
      • Yako, Region Nord, Burkina Faso
        • ALIMA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being between 6 and 59 months old
  • New admission

  • Acute malnutrition defined as follows:

    • MUAC<125mm
    • MUAC> 125mm AND WHZ (Z-score) <-3 (WHO standard)
    • Edema
  • Resident in the study area (Yako district)
  • Signed informed consent of the mother or the child's guardian

Exclusion Criteria:

  • Children allergic to milk, peanuts and / or RUTF

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MUAC<125mm
no medical complication
Drug: Ready to Use Therapeutic Food (RUTF)

MUAC used as the primary admission and exit criteria for children with MUAC <125mm and no medical complication.

Single treatment of RUTF for severe and moderate malnourished children and gradual reduction of doses according to the MUAC and the weight of the child during treatment. MUAC split into 3 categories:

  • MUAC <115 mm: 175 kcal /kg/day
  • 115
  • 120
Other Names:
  • MUAC<125mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery rate
Time Frame: Between 4 and 12 weeks

The recovery is defined as below :

  • Minimum of 4 weeks of participation in the program
  • MUAC> = 125 mm on 2 consecutive visits
  • No edema for minimum 2 weeks
  • Good Clinical Health
Between 4 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: Between inclusion and week 12
Between inclusion and week 12
Default rate
Time Frame: Between 3 and 12 weeks
Patient absent for 3 consecutive visits
Between 3 and 12 weeks
Non-respondent rate
Time Frame: 12 weeks after inclusion
Patient who not reach the recovery criteria after twelve weeks in the program
12 weeks after inclusion
Hospitalization rate
Time Frame: Between inclusion and week 12
Between inclusion and week 12
Relapse rate
Time Frame: up to 3 months

Patient having reached the recovery criteria and returning for a new episode of malnutrition (MUAC<125mm).

The children's MUAC will be measured at home 3 months after program exit. For organizational and financial reasons, this data will not be collected for all children. A specific protocol explaining the sampling and organization of data collection will be annexed to the protocol.
up to 3 months
RUTF rations
Time Frame: Between inclusion and week 12
Total number of RUTF bags received per child during participation in the program.
Between inclusion and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for International Medical Action

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
Institut de Recherche en Sciences de la Sante, Burkina Faso
Association Keoogo
SOS médecins Burkina Faso

Investigators

  • Principal Investigator: Susan Shepherd, MD, Directrice de recherches Opérationnelles et Médicales, ALIMA, USA
  • Principal Investigator: Renaud Becquet, MPH,PhD,HDR, Chercheur Inserm, Inserm U1219 Bordeaux Population Health Center-Université de Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (Estimate)

January 23, 2017

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUAC Only Burkina Faso

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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