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首页> 外文期刊>BMC Public Health >Research protocol of two concurrent cluster-randomized trials: Real-life Effect of a CAMPaign with Measles Vaccination (RECAMP-MV) and Real-life Effect of a CAMPaign with Oral Polio Vaccination (RECAMP-OPV) on mortality and morbidity among children in rural Guinea-Bissau
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Research protocol of two concurrent cluster-randomized trials: Real-life Effect of a CAMPaign with Measles Vaccination (RECAMP-MV) and Real-life Effect of a CAMPaign with Oral Polio Vaccination (RECAMP-OPV) on mortality and morbidity among children in rural Guinea-Bissau

机译：两种并发群集随机试验的研究方案：具有麻疹疫苗接种的运动的现实效果（Regamp-MV）和具有口服脊髓灰质炎疫苗接种（Regamp-OPV）对农村儿童死亡率和发病率的运动的现实效果几内亚比绍

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BACKGROUND:Measles and oral polio vaccinations may reduce child mortality to an extent that cannot be explained by prevention of measles and polio infections; these vaccines seem to have beneficial non-specific effects. In the last decades, billions of children worldwide have received measles vaccine (MV) and oral polio vaccine (OPV) through campaigns. Meanwhile the under-five child mortality has declined. Past MV and OPV campaigns may have contributed to this decline, even in the absence of measles and polio infections. However, cessation of these campaigns, once their targeted infections are eradicated, may reverse the decline in the under-five child mortality. No randomized trial has assessed the real-life effect of either campaign on child mortality and morbidity. We present the research protocol of two concurrent trials: RECAMP-MV and RECAMP-OPV.METHODS:Both trials are cluster-randomized trials among children registered in Bandim Health Project's rural health and demographic surveillance system throughout Guinea-Bissau. RECAMP-MV is conducted among children aged 9-59?months and RECAMP-OPV is conducted among children aged 0-8?months. We randomized 222 geographical clusters to intervention or control clusters. In intervention clusters, children are offered MV or OPV (according to age at enrolment) and a health check-up. In control clusters, children are offered only a health check-up. Enrolments began in November 2016 (RECAMP-MV) and March 2017 (RECAMP-OPV). We plan 18,000 enrolments for RECAMP-MV with an average follow-up period of 18?months and 10,000 enrolments for RECAMP-OPV with an average follow-up period of 10?months. Data collection is ongoing. The primary outcome in both trials is non-accidental death or non-accidental first non-fatal hospitalization with overnight stay (composite outcome). Secondary outcomes are: non-accidental death, repeated non-fatal hospitalizations with overnight stay, cause-specific primary outcome, outpatient visit, and illness. We obtained ethical approval from Guinea-Bissau and consultative approval from Denmark.DISCUSSION:Cluster randomization and minimum risk of loss to follow-up are strengths, and no placebo a limitation. Our trials challenge the understanding that MV and OPV only prevent measles and polio, and that once both infections are eradicated, campaigns with MV and OPV can be phased out without negative implications on child health and survival.TRIAL REGISTRATION:NCT03460002.
机译：背景：麻疹和口腔脊髓灰质炎疫苗接种可能会降低儿童死亡率，以便无法通过预防麻疹和脊髓灰质炎感染来解释;这些疫苗似乎具有有益的非特异性效果。在过去的几十年中，全球数十亿名儿童通过竞选人员接受了麻疹疫苗（MV）和口服脊髓灰质炎疫苗（OPV）。与此同时，五年的儿童死亡率下降。即使在没有麻疹和脊髓灰质炎感染的情况下，过去的MV和OPV运动可能会导致这种下降。然而，一旦将目标感染消除，可以停止这些竞选活动，可能会扭转五个儿童死亡率的下降。没有随机审判评估了儿童死亡率和发病率的现实效果。我们提出了两项​​并发试验的研究方案：重组 - MV和Recamp-OPV.methods：两项试验是在曾经几内亚比绍的班车卫生项目农村健康和人口监测系统中登记的儿童的集群随机试验。 Recamp-MV是在9-59岁的儿童进行的，月份和Recamp-OPV在0-8岁的儿童中进行。我们随机化222个地理集群到干预或控制集群。在干预群中，儿童提供MV或OPV（根据入学年龄）和健康检查。在控制集群中，儿童仅提供健康检查。入学始于2016年11月（Regamp-MV）和2017年3月（Regamp-OPV）。我们计划18,000人入门，用于进入MV，平均随访时间为18个月，10,000个月入学opv，平均随访10个月为10个月。数据收集正在进行中。两种试验中的主要结果是非意外死亡或非偶然的第一个非致命住院，过夜住宿（复合结果）。二次结果是：非意外死亡，重复非致命住院，过夜住院，造成特异性的主要结果，门诊性访问和疾病。我们从几内亚比绍和丹麦协商批准获得了道德批准.Discssion：集群随机化和后续行动损失的最小风险是优势，没有安慰剂限制。我们的审判挑战了MV和OPV仅预防麻疹和脊髓灰质炎，而且一旦根除所有感染，就可以逐步逐步淘汰MV和OPV的竞选，而不会对儿童健康和生存产生负面影响.NCT03460002。

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