Optimising management of uncomplicated acute malnutrition in children in rural Niger: a 3-arm individually randomised, controlled, noninferiority trial

The Optimising treatment for acute Malnutrition (OptiMA) and Combined Protocol for Acute Malnutrition Study (ComPAS) strategies aim to simplify acute malnutrition treatment programmes by treating severe and moderate cases with one product—ready-to-use therapeutic food (RUTF)—at gradually reduced doses.

This study aimed to evaluate the noninferiority of treatment under OptiMA and ComPAS compared with Niger’s standard protocol in children aged 6–59 months identified as malnourished by mid-upper arm circumference (MUAC) or edema. The randomised control trial was conducted in Niger 2021 to 2022. Children were assigned to either Standard, OptiMA, or ComPAS. Noninferiority, using 10% margin, was assessed in intention-to-treat (ITT) and per-protocol (PP) analyses.

Only the ComPAS protocol demonstrated noninferiority to standard treatment in ITT and PP analyses for children with MUAC <125 mm or edema. The OptiMA protocols lower performance is unclear, but it suggests that reduced RUTF dosage had limited influence on overall child growth, as ComPAS used less RUTF than OptiMA. For the most malnourished children with MUAC <115 mm or edema, the standard protocol showed a higher recovery proportion, primarily due to better attendance rather than differences in mortality or growth at 6 months.

Further studies are needed to better understand the acceptability and population-level impact of simplified protocols in multiple settings.