ComPAS Low-WAZ RCT Mali

Plain-language summary

Admissions criteria which treat children with only low mid-upper arm circumference (MUAC) or children with low weight-for-height z-score (WHZ) are not aligned with the evidence on which children are at risk of mortality. An analysis of community-based cohort data from Senegal found that a combination of weight-for-age z-score (WAZ) and MUAC criteria identified all children at risk of near-term death associated with severe anthropometric deficits. This finding has led to the suggestion that WAZ\<-3 could be added as an independent admissions criterion for therapeutic feeding programs currently admitting children with MUAC\<125 mm. However, there is little evidence to inform the debate about whether children with MUAC ≥125 mm and WAZ\<-3 would benefit from treatment and, if so, what treatment protocol should be used. This study will address whether children with WAZ \<-3 but MUAC ≥125 mm benefit from therapeutic feeding and whether a simplified protocol is at least as effective as the more complicated weight-based standard protocol for this population. The study will be a prospective, multi-center, individually randomized controlled trial (RCT). Children aged 6-59 months presenting with MUAC ≥125 mm and WAZ\<-3 will be randomized to one of three study arms. The primary objective of this study is to assess whether therapeutic feeding with a simplified protocol (1 sachet RUTF/day) results in superior nutritional outcomes compared to no therapeutic feeding AND non-inferior nutritional outcomes compared to the WHZ and weight based dosing regimen currently used in CMAM treatment 2 months after diagnosis among children aged 6-59 months with MUAC ≥125 mm and WAZ\<-3 . The primary outcome is the mean WAZ of children. Secondary outcomes include a) proportion of children with WAZ \<-3, b) mean MUAC of children, c) proportion of children with MUAC \< 125 mm, d) mean WHZ, mean HAZ, e) proportion of children with WHZ\<-3 or HAZ\<-3, f) change in WAZ, MUAC, WHZ, HAZ from enrolment to endpoint g) mean skinfold thickness measure.

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