The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial: Protocol for school-age follow-up.
The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) Trial: Protocol for school-age follow-up.
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DOI：
10.12688/wellcomeopenres.19463.1
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发表时间：
2023
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背景：有必要对儿童早期发育迟缓干预试验进行跟踪，以确定其长期影响。对健康、成长、身体和认知功能的全面学龄评估将有助于全面描述早期生活干预的持续影响。方法：在津巴布韦农村地区进行的环境卫生婴儿营养功效试验(SIRE)评估了改善婴幼儿喂养(IYCF)和/或改善水、卫生和个人卫生(WASH)对18个月时发育迟缓和贫血的影响。在登记参加SIRE的儿童中，1,275名儿童在7-8岁时接受了跟踪(1,000名未接触艾滋病毒的儿童，268名产前暴露于艾滋病毒的儿童，他们仍为艾滋病毒阴性，7名艾滋病毒阳性儿童)。使用学龄健康、活动、韧性、人体测量和神经认知(撒哈拉)工具箱对儿童进行评估，以衡量他们的生长、身体成分、认知和身体功能。与此同时，一份照顾者问卷评估了家庭人口统计、社会经济状况、逆境、养育、照顾者支持、食物和水的不安全。社区卫生工作者目前正在进行每月发病率问卷调查，以评估学龄期感染率和就医情况。将评估SIRE IYCF和WASH干预措施、早期生命‘暴露’、母亲艾滋病毒和当代暴露对每个学龄结局的影响。我们还将进行探索性因素分析，以产生新的、更简单的评估认知(COG-撒哈拉)、成长(成长-撒哈拉)和综合成长、认知和身体功能(撒哈拉以南)的指标。撒哈拉以南地区的工具箱将用于在8-12岁的SISH队列中进行年度评估。伦理和传播：获得津巴布韦医学研究理事会的批准(08/02/21)，并在泛非临床试验注册中心注册(PACTR202201828512110，24/01/22)。主要照顾者提供书面知情同意，儿童提供书面同意。调查结果将通过社区宣传、同行评议的期刊和包括津巴布韦卫生和儿童保育部在内的利益攸关方传播。
Background: There is a need for follow-up of early-life stunting intervention trials into childhood to determine their long-term impact. A holistic school-age assessment of health, growth, physical and cognitive function will help to comprehensively characterise the sustained effects of early-life interventions. Methods: The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial in rural Zimbabwe assessed the effects of improved infant and young child feeding (IYCF) and/or improved water, sanitation and hygiene (WASH) on stunting and anaemia at 18 months. Among children enrolled to SHINE, 1,275 have been followed up at 7-8 years of age (1,000 children who have not been exposed to HIV, 268 exposed to HIV antenatally who remain HIV negative and 7 HIV positive children). Children were assessed using the School-Age Health, Activity, Resilience, Anthropometry and Neurocognitive (SAHARAN) toolbox, to measure their growth, body composition, cognitive and physical function. In parallel, a caregiver questionnaire assessed household demographics, socioeconomic status, adversity, nurturing, caregiver support, food and water insecurity. A monthly morbidity questionnaire is currently being administered by community health workers to evaluate school-age rates of infection and healthcare-seeking. The impact of the SHINE IYCF and WASH interventions, the early-life ‘exposome’, maternal HIV, and contemporary exposures on each school-age outcome will be assessed. We will also undertake an exploratory factor analysis to generate new, simpler metrics for assessment of cognition (COG-SAHARAN), growth (GROW-SAHARAN) and combined growth, cognitive and physical function (SUB-SAHARAN). The SUB-SAHARAN toolbox will be used to conduct annual assessments within the SHINE cohort from ages 8–12 years. Ethics and dissemination: Approval was obtained from Medical Research Council of Zimbabwe (08/02/21) and registered with Pan-African Clinical Trials Registry (PACTR202201828512110, 24/01/22). Primary caregivers provided written informed consent and children written assent. Findings will be disseminated through community sensitisation, peer-reviewed journals and stakeholders including the Zimbabwean Ministry of Health and Child Care.