PLoS Medicine (Jul 2020)

A simplified, combined protocol versus standard treatment for acute malnutrition in children 6-59 months (ComPAS trial): A cluster-randomized controlled non-inferiority trial in Kenya and South Sudan.

  • Jeanette Bailey,
  • Charles Opondo,
  • Natasha Lelijveld,
  • Bethany Marron,
  • Pamela Onyo,
  • Eunice N Musyoki,
  • Susan W Adongo,
  • Mark Manary,
  • André Briend,
  • Marko Kerac

DOI
https://doi.org/10.1371/journal.pmed.1003192
Journal volume & issue
Vol. 17, no. 7
p. e1003192

Abstract

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BackgroundMalnutrition underlies 3 million child deaths worldwide. Current treatments differentiate severe acute malnutrition (SAM) from moderate acute malnutrition (MAM) with different products and programs. This differentiation is complex and costly. The Combined Protocol for Acute Malnutrition Study (ComPAS) assessed the effectiveness of a simplified, unified SAM/MAM protocol for children aged 6-59 months. Eliminating the need for separate products and protocols could improve the impact of programs by treating children more easily and cost-effectively, reaching more children globally.Methods and findingsA cluster-randomized non-inferiority trial compared a combined protocol against standard care in Kenya and South Sudan. Randomization was stratified by country. Combined protocol clinics treated children using 2 sachets of ready-to-use therapeutic food (RUTF) per day for those with mid-upper arm circumference (MUAC) ConclusionsCombined treatment for SAM and MAM is non-inferior to standard care. Further research should focus on operational implications, cost-effectiveness, and context (Asia versus Africa; emergency versus food-secure settings). This trial is complete and registered at ISRCTN (ISRCTN30393230).Trial registrationThe trial is registered at ISRCTN, trial number ISRCTN30393230.