About this trial
This experimental study aims to test an alternative protocol for managing acute malnutrition in children aged 6-59 months in Burkina Faso. This alternative protocol consists of using RUTF instead of RUSF for the management of moderate acute malnutrition and reduced-dose RUTF instead of standard-dose RUTF for the treatment of severe acute malnutrition.
The main questions are:
1. Does treating children with moderate acute malnutrition using RUTF lead to a non-inferior programmatic and sustained recovery rate compared to the standard care with RUSF? 2. Does treating children with uncomplicated severe acute malnutrition using a reduced dose of RUTF lead to a non-inferior programmatic and sustained recovery rate compared to the standard care with a standard dose of RUFT?
Secondly, the study will investigate the effect of this alternative protocol compared to the standard protocol on cost-effectiveness, psychomotor development, weight and linear growth and incidence of relapses.
Eligibility criteria
Qualifiers
MAM
(115 mm ≤ MUAC< 125 mm and -3 SDs ≤ WLZ < -2 SDs) OR
(115 mm ≤ MUAC< 125 mm and WLZ ≥ -2 SDs) OR
(MUAC ≥ 125 mm and -3 SDs ≤ WLZ < -2 SDs).
Disqualifiers
Failure of appetite test
Medical complications requiring hospital treatment
Presence of any congenital anomaly or underlying chronic disease that may affect growth or the risk of infection
Presence of bilateral oedema
Trial design
Treatments tested in this trial
- ready-to-use therapeutic food (for children with MAM)
- Ready-to-use supplementary food
- Ready to Use Therapeutic Food - Reduced dose 1
- Ready to Use Therapeutic Food - Standard dose
- Ready to Use Therapeutic Food - Reduced dose 2
Treatment groups
Sponsors and collaborators
Institut de Recherche en Sciences de la Sante, Burkina Faso
Lead sponsor
Bill and Melinda Gates Foundation
Collaborator