Effectiveness of a reduced dose of ready-to-use therapeutic food (RUTF) in the management of uncomplicated severe acute malnutrition (SAM)

Current primary outcome measure as of 25/03/2022:
Weight gain velocity (g/kg/d) measured using scales weekly from admission to discharge

Previous primary outcome measure as of 31/01/2022:
Weight (kg) measured using scales weekly between admission and discharge, and then fortnightly after discharge for up to 3 months


Previous primary outcome measure:
Weight (kg) measured using scales at admission, at discharge, and then every 15 days up to 3 months

Current secondary outcome measures as of 31/01/2022:
1. Acceptance of a reduced dose during SAM treatment by health care personnel and the community measured using discussion groups, in-depth interviews, and direct observation using interview and focus group guides as well as observation grids in November 2021. This survey will assess the perceptions of families and health care providers on the amount of RUTF received, consumption and use practices, and their attitude towards a possible dose reduction.
2. Relapse rate measured as the proportion of children treated for SAM and declared cured who revert to SAM within 3 months of completing treatment, using anthropometric measurements including weight (kg), height (cm), and arm circumference (mm) taken using scales, height chart and tape measure at 3 months after treatment
3. Psychomotor development measured using the Psychomotor Development Index (PDI) at admission, discharge, and 6 months after treatment
4. Duration of the edema melting measured as the number of days taken for the lower limbs of SAM children to return to their normal volume using a tape measure at all study visits
5. Length of stay measured as the number of days between admission and discharge (with discharge occurring at PB≥12.5 cm and/or PT ≥-3 z-score and/or edema melt). The maximum length of stay is 12 weeks or 3 months
6. The cure rate measured as meeting the cure criteria according to admission category during two consecutive visits and no edema during two visits in two consecutive weeks measured using PT index (≥-1.5) or PB (≥125 mm) and edema at all study visits
7. The dropout rate measured as the proportion of children confirmed alive who missed two successive visits, at all study visits. The abandonment is confirmed once after the visit of the RECO which confirms that the child is alive despite his 2 absences during the weekly visits. Children who have been abandoned will be followed up to 3 months after the abandonment. For children who can be found, offer the caregivers a small snack at a single appointment 3 months after abandonment to take the anthropometric measurements.
8. Death rate measured as the proportion of children randomized to the study who died during the intervention at any time
9. Cost savings (average cost saved and cost saved per child treated) measured by comparing the cost of treatment for children in care and declared cured in the two groups using the direct costs of drugs and RUTF (purchase, transport, transport, and storage) to assess the cost for each child, the HR costs involved in the care, the non-medical costs (food and transport. beneficiaries), and indirect costs (loss of productivity) throughout the trial
10. Prevalence of stunting and being underweight measured using anthropometric measurements including weight (kg), height (cm), and arm circumference (mm) taken using scales, height chart, and tape measure at the end of the treatment.


Previous secondary outcome measures:
1. Acceptance of a reduced dose during SAM treatment by health care personnel and the community: this involves assessing the perceptions of families and health care providers on the amount of RUTF received, consumption and use practices and their attitude towards a possible dose reduction. Assessed using a qualitative approach by organizing discussion groups, in-depth interviews and direct observation using interview and focus group guides as well as observation grids. This survey was conducted in November 2021
2. Relapse rate: the proportion of children treated for SAM and declared cured who revert to SAM within 3 months of completing treatment, assessed using anthropometric measurements including weight (kg), height (cm) and arm circumference (mm) taken using scales, height chart and tape measure
3. Psychomotor development: this sub-study aims to assess the proportion of children with psychomotor developmental delay (PDD) and to monitor their progress during treatment. Psychomotor developmental delay (PDD) refers to impairments in the acquisition of skills and competencies in the areas of language, cognitive, motor, and social interaction. PDD corresponds to a score of less than 70% in two of the four domains of Psychomotor Development (DPM) at admission, discharge, and 6 months after treatment. In this substudy, it is expected that the DPM of children with Psychomotor Development Delay (RDPM) will improve after treatment simply as a result of medical and nutritional intervention without any specific action on the DPM during treatment.