Combined Protocol for Acute Malnutrition Study (ComPAS) in rural South Sudan and urban Kenya: study protocol for a randomized controlled trial.

Jeanette Bailey, Natasha Lelijveld, Bethany Marron, Pamela Onyoo, Lara S Ho, Mark Manary, André Briend, Charles Opondo, Marko Kerac

Journal: Trials 2019;19(1):251

PMID: 29690916

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Abstract

BACKGROUND

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 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/DESIGN

This 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.

DISCUSSION

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 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 REGISTRATION

ISRCTN, ISRCTN30393230 . Registered on 16 March 2017.

Address: International Rescue Committee, New York, NY, USA. [email protected].; Department of Population Health, MARCH Centre, London School of Hygiene and Tropical Medicine, London, UK. [email protected].; Department of Population Health, MARCH Centre, London School of Hygiene and Tropical Medicine, London, UK.; No Wasted Lives, Action Against Hunger-UK, London, UK.; International Rescue Committee, New York, NY, USA.; Action Against Hunger-USA, New York, NY, USA.; Department of Pediatrics, Washington University School of Medicine in St. Louis, St. Louis, MO, USA.; Department of International Health, University of Tampere, Tampere, Finland.; Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.

DOI: 10.1186/s13063-018-2643-2

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MeSH Terms: Acute Disease, Age Factors, Child Development, Child Health Services, Child Nutrition Disorders, Child Nutritional Physiological Phenomena, Child, Preschool, Equivalence Trials as Topic, Female, Food, Formulated, Food, Fortified, Humans, Infant, Infant Nutrition Disorders, Kenya, Male, Malnutrition, Multicenter Studies as Topic, Nutrition Therapy, Nutritional Status, Rural Health Services, Sudan, Time Factors, Treatment Outcome, Urban Health Services, Weight Gain