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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Combined Protocol for Acute Malnutrition Study (ComPAS) in rural South Sudan and urban Kenya: Study protocol for a randomized controlled trial
Trials, Volume 19, No. 1, Article 251, Year 2018
Notification
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Description
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. © 2018 The Author(s).
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC5978994/bin/13063_2018_2643_MOESM1_ESM.docx
https://efashare.b-cdn.net/share/pmc/articles/PMC5978994/bin/13063_2018_2643_MOESM2_ESM.docx
Authors & Co-Authors
Bailey, Jeanette
United States, New York
International Rescue Committee, new York
United Kingdom, London
London School of Hygiene & Tropical Medicine
Lelijveld, Natasha
United Kingdom, London
London School of Hygiene & Tropical Medicine
United Kingdom, London
No Wasted Lives
Marron, Bethany
United States, New York
International Rescue Committee, new York
Ho, Lara Shiu Yi
United States, New York
International Rescue Committee, new York
Manary, Mark J.
United States, St. Louis
Washington University School of Medicine in St. Louis
Briend, André
Finland, Tampere
Tampere University
Denmark, Copenhagen
Københavns Universitet
Opondo, Charles
United Kingdom, London
London School of Hygiene & Tropical Medicine
Kerac, Marko
United Kingdom, London
London School of Hygiene & Tropical Medicine
Statistics
Citations: 25
Authors: 8
Affiliations: 7
Identifiers
Doi:
10.1186/s13063-018-2643-2
ISSN:
17456215
Research Areas
Food Security
Health System And Policy
Maternal And Child Health
Study Design
Randomised Control Trial
Study Approach
Quantitative
Study Locations
Kenya
South Sudan
Sudan