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.
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).
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
Parallel
ready-to-use therapeutic food (for children with MAM)
Dietary supplementEach child with MAM will be supplemented with RUTF for a maximum of 12 weeks. He/she will be followed subsequently up to 24 weeks.
Ready-to-use supplementary food
Dietary supplementEach child with MAM will be supplemented with RUSF for a maximum of 12 weeks. He/she will be followed subsequently up to 24 weeks post recovery
Ready to Use Therapeutic Food - Reduced dose 1
Dietary supplementEach child with SAM will be treated with a reduced dose for a maximum of 12 weeks : dose of 150-185 kcal/kg/day of RUTF until programmatic recovery. He/she will be followed subsequently up to 24 weeks post recovery.
Ready to Use Therapeutic Food - Standard dose
Dietary supplementEach child with SAM will be treated with a standard dose (according to the national protocol for the integrated management of acute malnutrition in Burkina Faso) for a maximum of 12 weeks. He/she will be followed subsequently up to 24 weeks post recovery.
Ready to Use Therapeutic Food - Reduced dose 2
Dietary supplementEach child with SAM will be treated with a reduced dose for a maximum of 12 weeks : dose of 150-185 kcal/kg/day of RUTF until the child is no longer severely malnourished and does not have nutritional oedema then 100-130 kcal/kg/day of RUTF until programmatic recovery. He/she will be followed subsequently up to 24 weeks post recovery.
Rate of programmatic recovery
Number of children with a MUAC ≥ 125 mm and WLZ≥ -2 standard deviations for two consecutive visits at or before twelve (12) weeks since admission to the supplementation program in an arm divided by total number of children enrolled in the arm
Rate of sustained recovery
Number of children who maintain a MUAC ≥ 125 mm and WLZ≥ -2 SDs three (03) months after the programmatic recovery in an arm divided by total number of children with a programmatic recovery in the arm
Cost per child treated
Economic metric obtained by dividing the total costs for an arm by the number of children who received treatment in this arm
Cost per child recovered
Economic metric obtained by dividing the total costs for an arm by the number of children recovered in this arm
Score of the extended version of Developmental Milestones Checklist (DMC-II)
Psychomotor development of children aged 6-23 months will be assessed by a tool adapted for sub-Saharan Africa countries settings : the extended version of Developmental Milestones Checklist (DMC-II). DMC-II have 76 items and each item is scored from 0 to 2 :zero if the child has not yet started doing the skill, one if the child has been able to perform the skill in the past four weeks but not continually, two if the child has been able to perform the skill for the past four weeks continually. Thus, the minimum value of this score is 0 (indicating no developmental milestones achieved) and the maximum is 152 (full developmental milestones achieved).Higher scores indicate better developmental outcomes, reflecting more advanced motor, language, and personal-social skills.
Daily weight gain
Refers to the increase in weight during the study period and is obtained by dividing the total weight gain in kilogram by the number of days since admission to the exit of the programme
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Institut de Recherche en Sciences de la Sante, Burkina Faso
Lead sponsor
Bill and Melinda Gates Foundation
Collaborator
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