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

Alliance for International Medical Action

Status: Completed

Conditions: Global Acute Malnutrition (GAM)

Treatments: Drug: Ready to Use Therapeutic Food (RUTF)

Study type: Interventional

Funder types: Other

Identifiers

NCT03027505

MUAC Only Burkina Faso

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,958 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4,958 participants in 1 patient group

MUAC<125mm

Experimental group

Description:

no medical complication

Treatment:

Drug: Ready to Use Therapeutic Food (RUTF)