Simplified and optimised management of acute malnutrition in children aged 6 to 59 months: OptiMA-Niger, a community-based clinical randomized controlled trial in the Mirriah district in Niger

Principal Investigator:  Susan Shepherd, ALIMA & Renaud Becquet, INSERM

Research Snapshot: Simplifying treatment for malnutrition in humanitarian crises

This randomised trial adds to the evidence base to strengthen the response to malnutrition in emergencies, demonstrating that two alternative simplified protocols for treating malnutrition show promise for continued use in humanitarian settings.

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What did the study set out to achieve?

Acute malnutrition is a significant threat to child survival in Sub Saharan Africa. Children with severe and moderate acute malnutrition are currently treated separately, using different protocols and nutritional products, which is complex and costly. The two ‘simplified / combined’ protocols address this by using only mid-upper arm circumference (MUAC) or oedema for admission and discharge with one treatment product (RUTF) – at reduced dosage as a child’s condition improves. However, more evidence is needed to inform decision-making on these strategies.

Children aged 6 months to <5 years, identified as malnourished by MUAC/oedema, were randomly assigned to one of three groups: OptiMA, ComPAS, and standard Nigerien treatment (control), and monitored for 6 months. The primary outcome looked at children successfully treated (alive/without relapse). Secondary outcomes focused on recovery rates of severely malnourished children.

What were the key findings?

This randomised trial showed that the simplified protocols did not harm the children or affect their weight gain compared with the standard protocol - while using less ready to use therapeutic food (RUTF), suggesting cost savings. ComPAS appears to be the best balance of cost, effectiveness, and resource use, especially under limited budgets. Importantly, reduced RUTF dosages did not appear to slow growth among the most severely malnourished. The evidence on simplified approaches is now being used to inform scale-up in sub-Saharan Africa, and policy guidelines for humanitarian response.

• Both new treatments (ComPAS and OptiMA) worked as well as the standard treatment when looking at all 1732 children for the primary outcome (the "intention to treat" group). However, when looking only at children treated exactly as planned (the "per protocol" group), only ComPAS matched the standard treatment's success.
• On the secondary outcome (1440 most severely malnourished children) neither ComPAS nor OptiMA matched the standard treatment in ensuring recovery. However, children who nearly recovered (but only met recovery criteria for one week) were similar across all treatments.
• Children's growth over six months was similar for ComPAS but slower for OptiMA.
• ComPAS used 37% less food (RUTF) compared to the standard treatment. OptiMA used 15% less for the primary outcome and 32% less for the secondary outcome. Overall, OptiMA was more expensive and less effective than ComPAS; while using the standard treatment instead of ComPAS would cost an extra $760 per additional recovery.

What does this mean for policymakers and practitioners?

ComPAS appears to be the best balance of cost, effectiveness, and resource use, especially under limited budgets.
Based on this evidence, in collaboration with the Directorate of Nutrition in the Niger Ministry of Health ALIMA is working to scale-up simplified approaches in Niger, and this could be considered in similar settings.

Policymakers addressing malnutrition in conflict-affected and humanitarian settings particularly in sub-Saharan Africa are now considering the evidence on both OptiMA and ComPAS to inform policies guiding humanitarian response, including recently revised WHO guidelines.

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