Abstract
BackgroundAcute malnutrition is a continuum condition, but severe and moderate forms are treated separately, with different protocols and therapeutic products, managed by separate United Nations agencies. The Combined Protocol for Acute Malnutrition Study (ComPAS) aims to simplify and unify the treatment of uncomplicated severe and moderate acute malnutrition (SAM and MAM) for children 6–59 months into one protocol in order to improve the global coverage, quality, continuity of care and cost-effectiveness of acute malnutrition treatment in resource-constrained settings.Methods/designThis study is a multi-site, cluster randomized non-inferiority trial with 12 clusters in Kenya and 12 clusters in South Sudan. Participants are 3600 children aged 6–59 months with uncomplicated acute malnutrition. This study will evaluate the impact of a simplified and combined protocol for the treatment of SAM and MAM compared to the standard protocol, which is the national treatment protocol in each country. We will assess recovery rate as a primary outcome and coverage, defaulting, death, length of stay, average weekly weight gain and average weekly mid-upper arm circumference (MUAC) gain as secondary outcomes. Recovery rate is defined across both treatment arms as MUAC ≥125 mm and no oedema for two consecutive visits. Per-protocol and intention-to-treat analyses will be conducted.DiscussionIf the combined protocol is shown to be non-inferior to the standard protocol, updating guidelines to use the combined protocol would eliminate the need for separate products, resources and procedures for MAM treatment. This would likely be more cost-effective, increase availability of services, enable earlier case finding and treatment before deterioration of MAM into SAM, promote better continuity of care and improve community perceptions of the programme.Trial registrationISRCTN, ISRCTN30393230. Registered on 16 March 2017.
Highlights
Acute malnutrition is a continuum condition, but severe and moderate forms are treated separately, with different protocols and therapeutic products, managed by separate United Nations agencies
If the combined protocol is shown to be non-inferior to the standard protocol, updating guidelines to use the combined protocol would eliminate the need for separate products, resources and procedures for moderate acute malnutrition (MAM) treatment
This study explored the efficacy of an integrated severe acute malnutrition (SAM)/MAM treatment protocol using one product (RUTF) but at different doses for children
Summary
Acute malnutrition is a continuum condition, but severe and moderate forms are treated separately, with different protocols and therapeutic products, managed by separate United Nations agencies. The true burden of disease is likely much higher This is because most current estimates are based on cross-sectional survey data giving prevalence figures, whereas SAM and MAM, being short-lasting conditions, should ideally be assessed in terms of incidence [2, 3]. Figures for MAM programme coverage are unknown—but are likely to be lower since it is often perceived to be less of a priority compared to SAM. This is despite wasting, the major manifestation of both SAM and MAM, being on a continuum, with the cut-off between the two defined statistically (based on weight-forheight/length standard deviations from the median) rather than by any distinguishable clinical changes
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