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.
In this trial, children presenting at the health center and fulfilling the inclusion criteria will be randomly allocated into one of the study groups in a ratio of 1:1:1 for severe acute malnutrition (SAM) without complication and 1:1 for moderate acute malnutrition (MAM). Supplementation will be daily according to the child's weight for a maximum of 12 weeks, at which point the programmatic recovery assessment will be done. Those who recovered before or at this point will be subsequently followed up monthly for up to 3 months for sustained recovery assessment. Follow-up visits will be done at the health center every week for children with SAM and every two weeks for children with MAM. At each visit, anthropometric measurements will be performed; a morbidity questionnaire will be administered before the mother/caregiver receives the ration for the following period. For the measurement of adherence, mothers will be asked to bring back empty and unused sachets/packaging of supplements from the last visit. Questions will also be asked to the mother/caregiver on the difficulties encountered during consumption and the adverse events observed following the consumption of the supplements. The evaluation of the psychomotor development will be performed in a subsample.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,521
Each child with MAM will be supplemented with RUTF for a maximum of 12 weeks. He/she will be followed subsequently up to 24 weeks.
Each 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
Each 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.
Each 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.
Each 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.
Institut de Recherche en Sciences de la Santé
Ouagadougou, KADIOGO, Burkina Faso
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
Time frame: From enrollment to the end of treatment (maximum 12 weeks)
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
Time frame: from programmatic recovery to 3 months after
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
Time frame: From enrollment to the end of treatment (maximum 12 weeks)
Cost per child recovered
Economic metric obtained by dividing the total costs for an arm by the number of children recovered in this arm
Time frame: From enrollment to the end of treatment (maximum 12 weeks)
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.
Time frame: Three points : enrollment , exit of the supplementation program (up to 12 weeks) and exit of the study (3 months after recovery)
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
Time frame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)]
Daily length gain
Refers to the increase in length during the study period and is obtained by dividing the total length gain in centimetre by the number of days since admission to the exit of the supplementation programme (maximum 12 weeks)
Time frame: [Time Frame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)
Energy intake
Daily average of calories per kilogram obtained from the 24-hour recall
Time frame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)
Rate of relapses
Number of children who return malnourished after programmatic recovery divided by the number of children with programmatic recovery
Time frame: from programmatic recovery to 3 months after
Length of stay
Duration in days from admission to programmatic recovery
Time frame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)
Rate of defaulted
Number of children absent for three (3) consecutive visits in an arm divided of total number of children enrolled in the arm
Time frame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)
Rate of treatment failure
Number of participants with no weight gain after 5 weeks or at the third visit OR weight loss for more than 4 weeks in the program or at the second visit OR weight loss of more than 5% of body weight compared to admission weight at any time OR failure to meet discharge criteria after 3 months in an arm divided by total number of children enrolled in the arm
Time frame: From enrollment to the end of treatment (maximum 12 weeks)
Number of adverse events
Number of incidents in which the use of the dietary supplement or data collection procedures is suspected to have contributed. This can be a physical event (e.g., a rash); a laboratory event (e.g., elevated blood sugar), or an increase in the severity or frequency of a pre-existing symptom or condition
Time frame: From enrollment to the exit of the supplementation programme (maximum 12 weeks)
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