Integrated Treatment Protocol for Acute Malnutrition: A Non Inferiority Trial in Burkina Faso
Condition: Global Acute Malnutrition (GAM)
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Ready to Use Therapeutic Food (RUTF)
Intervention type(s): Drug
Intervention description(s): 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 <MUAC <120mm: 125kcal/kg/day
120 <MUAC <125mm: 75kcal/kg/day
Other intervention name(s): MUAC<125mm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MUAC; Acute malnutrition; RUTF; Children; Burkina Faso