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首页> 外文期刊>BMC Infectious Diseases >The Safe Start trial to assess the effect of an infant hygiene intervention on enteric infections and diarrhoea in low-income informal neighbourhoods of Kisumu, Kenya: a study protocol for a cluster randomized controlled trial
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The Safe Start trial to assess the effect of an infant hygiene intervention on enteric infections and diarrhoea in low-income informal neighbourhoods of Kisumu, Kenya: a study protocol for a cluster randomized controlled trial

机译：安全开始试验，以评估婴儿卫生干预对肯尼亚的低收入非正式社区肠道感染和腹泻的影响：肯尼亚的低收入非正式社区的腹泻：集群随机对照试验的研究议定书

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BACKGROUND:Symptomatic and asymptomatic enteric infections in early childhood are associated with negative effects on childhood growth and development, especially in low and middle-income countries, and food may be an important transmission route. Although basic food hygiene practices might reduce exposure to faecal pathogens and resulting infections, there have been few rigorous interventions studies to assess this, and no studies in low income urban settings where risks are plausibly very high. The aim of this study is to evaluate the impact of a novel infant food hygiene intervention on infant enteric infections and diarrhoea in peri-urban settlements of Kisumu, Kenya.METHODS:This is a cluster randomized control trial with 50 clusters, representing the catchment areas of Community Health Volunteers (CHVs), randomly assigned to intervention or control, and a total of 750 infants recruited on a rolling basis at 22?weeks of age and then followed for 15?weeks. The intervention targeted four key caregiver behaviours related to food hygiene: 1) hand washing with soap before infant food preparation and feeding; 2) bringing all infant food to the boil before feeding, including when reheating or reserving; 3) storing all infant food in sealed containers; and, 4) using only specific utensils for infant feeding which are kept separate and clean.RESULTS:The primary outcome of interest is the prevalence of one or more of 23 pre-specified enteric infections, determined using quantitative real-time polymerase chain reaction for enteric pathogen gene targets. In addition, infant food samples were collected at 33?weeks, and faecal indicator bacteria (Enterococcus) isolated and enumerated to assess the impact of the intervention on infant food contamination.CONCLUSION:To our knowledge this is the first randomized controlled trial to assess the effect of an infant food hygiene intervention on enteric infections in a high burden, low income urban setting. Our trial responds to growing evidence that food may be a key pathway for early childhood enteric infection and disease and that basic food hygiene behaviours may be able to mitigate these risks. The Safe Start trial seeks to provide new evidence as to whether a locally appropriate infant food hygiene intervention delivered through the local health extension system can improve the health of young children.TRIAL REGISTRATION:The trial was registered at clinicaltrial.gov on March 16th 2018 before enrolment of any participants (https://clinicaltrials.gov/ct2/show/NCT03468114).
机译：背景：幼儿早期的症状性和无症状肠溶感染与儿童增长和发展的负面影响有关，特别是在低中和中等收入国家，食物可能是一个重要的传输路线。虽然基本食品卫生实践可能会降低粪便病原体和导致感染的暴露，但是很少有严格的干预措施研究来评估这一点，并且在低收入城市环境中没有研究，其中风险很高。本研究的目的是评估新的婴儿食品卫生干预对Kenya，Kenya的围住肠道肠道感染和腹泻的影响。这是一个群集随机控制试验，其中50个集群，代表了集水区社区健康志愿者（CHVS），随机分配到干预或控制，共有750名婴儿在22个月的22周内招募，然后持续15？周。干预针对与食品卫生有关的四项关键护理行为：1）用肥皂在婴儿食品准备和喂养之前洗手; 2）在喂食之前将所有婴儿食品带到沸腾，包括在再加热或保留时; 3）将所有婴儿食品存放在密封容器中;并且，4）仅使用特定的器具进行婴儿饲养，其保持分离和清洁。结果：利益的主要结果是使用定量实时聚合酶链反应测定的23例预定肠溶感染中的一个或多个或多种的患病率肠道病原体基因靶标。此外，婴儿食物样品在33℃，粪便指标细菌（肠球菌）被隔离并列举，以评估干预对婴儿食品污染的影响。结论：对于我们的知识，这是评估的第一个随机对照试验婴幼儿食品卫生干预对高负荷，低收入城市环境中肠溶感染的影响。我们的审判响应了日益增长的证据表明食物可能是儿童肠道感染和疾病的关键途径，并且基本的食物卫生行为可能能够减轻这些风险。安全开始试验旨在提供通过当地健康延伸系统提供的当地适当的婴儿食品卫生干预，可以改善年轻儿童的健康.Trial注册：审判在2018年3月16日之前在Clinicaltrial.gov注册注册任何参与者（https://clinicaltrials.gov/ct2/show/nct03468114）。

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