Bailey Jeanette, Lelijveld Natasha, Marron Bethany, Onyoo Pamela, Ho Lara S, Manary Mark, Briend André, Opondo Charles, Kerac Marko
International Rescue Committee, New York, NY, USA.
Department of Population Health, MARCH Centre, London School of Hygiene and Tropical Medicine, London, UK.
Trials. 2018 Apr 24;19(1):251. doi: 10.1186/s13063-018-2643-2.
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.
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.
ISRCTN, ISRCTN30393230 . Registered on 16 March 2017.
急性营养不良是一种连续状态，但重度和中度形式需分别治疗，采用不同方案和治疗产品，由不同联合国机构管理。急性营养不良联合方案研究（ComPAS）旨在将6至59个月儿童单纯性重度和中度急性营养不良（SAM和MAM）的治疗简化并统一为一个方案，以提高资源受限环境下急性营养不良治疗的全球覆盖率、质量、护理连续性和成本效益。
方法/设计：本研究是一项多中心、整群随机非劣效性试验，在肯尼亚有12个群组，在南苏丹有12个群组。参与者为3600名6至59个月患有单纯性急性营养不良的儿童。本研究将评估与标准方案（即每个国家的国家治疗方案）相比，简化联合方案治疗SAM和MAM的效果。我们将评估恢复率作为主要结局，覆盖率、失访率、死亡率、住院时间、平均每周体重增加和平均每周上臂中部周长（MUAC）增加作为次要结局。两个治疗组的恢复率定义为MUAC≥125毫米且连续两次就诊无水肿。将进行符合方案分析和意向性分析。
如果联合方案被证明不劣于标准方案，更新指南以使用联合方案将消除对MAM治疗使用单独产品、资源和程序的需求。这可能更具成本效益，增加服务可及性，使能在MAM恶化为SAM之前更早地发现和治疗病例，促进更好的护理连续性，并改善社区对该方案的认知。
ISRCTN，ISRCTN30393230。于2017年3月16日注册。
