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

Authors: BAILEY, JEANETTE - London School Of Hygiene & Tropical Medicine; LELIJVELD, NATASHA - London School Of Hygiene & Tropical Medicine; MARRON, BETHANY - International Rescue Committee; ONYOO, PAMELA - Action Against Hunger; HO, LARA - International Rescue Committee; MANARY, MARK - Children'S Nutrition Research Center (CNRC); BRIEND, ANDRE - University Of Tampere; OPONDO, CHARLES - London School Of Hygiene & Tropical Medicine; KERAC, MARKO - London School Of Hygiene & Tropical Medicine

Submitted to: Trials
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 4/11/2018
Publication Date: 4/24/2018
Citation: Bailey, J., Lelijveld, N., Marron, B., Onyoo, P., Ho, L.S., Manary, M., Briend, A., Opondo, C., Kerac, M. 2018. Combined Protocol for Acute Malnutrition Study (ComPAS) in rural South Sudan and urban Kenya: A study protocol for a randomized controlled trial. Trials. 19(1):251. https://doi.org/10.1186/s13063-018-2643-2.
DOI: https://doi.org/10.1186/s13063-018-2643-2

Interpretive Summary: Severe and moderate forms of malnutrition are treated with different products by different agencies. These combined instructions aim to simplify the treatment of malnutrition in order to improve global coverage, quality, continuity of care and cost-effectiveness of malnutrition treatment; children following this combined treatment method are expected to recover the same as children following the traditional methods. By bundling these nutritional and anti-infective interventions, this study aims to reduce growth restriction of babies in utero and low birth weights of children from malnourished pregnant women in Sierra Leone.

Technical Abstract: 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. 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. 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.