BACKGROUND In 2019, Nigeria reported the highest mortality rate in children younger than 5 years globally. We aimed to assess a whole-systems approach to improving child mortality in northern Nigeria. METHODS We conducted a community-based, parallel-arm, pragmatic, cluster randomised controlled trial in Kiyawa local government area, Jigawa state, Nigeria, and a concurrent mixed-methods process evaluation using ethnography and quantitative implementation monitoring. Trial clusters were population catchment areas of 32 government primary health-care facilities. Compounds were randomly sampled, proportional to cluster size, and all women aged 16-49 years and children younger than 5 years who were permanent residents were eligible for inclusion and recruited as the evaluation population. Children younger than 7 days were recruited but excluded from analysis. Evaluation clusters were allocated to intervention or control via simple randomisation with a 1:1 ratio. Cluster names were written on paper, folded, and placed in a container by community representatives. Different community representatives took out names one by one, with the first half assigned to receive the intervention. The intervention consisted of three components: participatory learning and action (PLA) groups for men and women (including compound heads [ie, the member of the compound that residents deemed most senior]), partnership defined quality scorecard (PDQS), and health-care worker capacity building; it was delivered from March 1, 2021, to Dec 31, 2022. We could not mask participants, field staff, or intervention-delivery staff to cluster allocation but baseline, endline, and follow-up data excluded information on cluster allocation. PLA groups involved separate groups of up to 25 men or women from all villages in the intervention clusters. The primary outcome was all-cause mortality in children aged 7 days to 59 months between Oct 1, 2021, and Sept 20, 2022, referred to as the evaluation period. The trial was prospectively registered (ISRCTN 39213655) and the protocol has been published. FINDINGS We recruited 3800 compounds at baseline, with 12 893 children contributing to analysis of the primary outcome (7316 [56·8%] of 12 893 in the intervention group and 5577 [43·3%] in the control group). 6617 (51·3%) of 12 893 children were male, 6275 (48·7%) were female, and one (<0·1%) child had missing sex data. Sampled compounds randomly came from 388 (91·3%) of 425 villages in the 32 clusters. We conducted verbal autopsies for 1182 deaths, of which 369 (31·2%) were children aged 7 days to 59 months during the evaluation period. Of these 369, 91 (24·7%) were classified as pneumonia deaths. Children contributed a median 361 days (IQR 236-365) to the analysis, with 369 (2·9%) of 12 893 children censored on their date of death, 1545 (12·0%) on their 5th birthday, and 3392 (26·3%) on the date of the most recent follow-up in which their residence or survival status was known. We found no significant decrease in all-cause mortality (hazard ratio 0·95, 95% CI 0·68-1·33; p=0·79) or suspected pneumonia mortality (0·79, 0·43-1·46; p=0·46) in the intervention group. The process evaluation showed low coverage and issues in reach of the intervention, but qualitative data highlighted mechanisms for positive effects on health and relationships. INTERPRETATION Our intervention did not affect mortality. However, due to the high child mortality in this region, further efforts should be made to adapt our participatory whole-systems approach to use communities of action within compounds. FUNDING GSK and Save the Children UK. TRANSLATION For the Hausa translation of the abstract see Supplementary Materials section.

中文翻译：

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尼日利亚吉加瓦州参与式全系统方法对 5 岁以下儿童死亡率的影响（INSPIRING 试验）：一项基于社区、平行臂、务实、整群随机对照试验和同步混合方法过程评估。


背景 2019 年，尼日利亚报告的 5 岁以下儿童死亡率全球最高。我们旨在评估改善尼日利亚北部儿童死亡率的全系统方法。方法 我们在尼日利亚吉加瓦州 Kiyawa 地方政府区域进行了一项基于社区的、平行臂的、务实的、整群随机对照试验，并使用民族志和定量实施监测进行同步混合方法过程评估。试验集群是 32 个政府初级卫生保健机构的人口集水区。根据簇大小对化合物进行随机采样，所有 16-49 岁的女性和 5 岁以下的永久居民儿童都有资格纳入并被招募为评估人群。招募了 7 天以下的儿童，但被排除在分析之外。通过简单的随机化以 1：1 的比例将评估集群分配给干预或对照。社区代表将集群名称写在纸上、折叠并放入容器中。不同的社区代表一个接一个地抽出名字，上半部分被分配接受干预。干预包括三个部分：男性和女性参与式学习和行动 （PLA） 小组（包括复合负责人 [即，居民认为最资深的复合体成员]）、伙伴关系定义质量评分卡 （PDQS） 和医护人员能力建设;它于 2021 年 3 月 1 日至 2022 年 12 月 31 日交付。我们无法对受试者、现场工作人员或干预实施人员进行分组分配，但基线、终点和随访数据排除了有关分组分配的信息。 PLA 小组涉及来自不同村庄的最多 25 名男性或女性的干预集群。主要结局是 2021 年 10 月 1 日至 2022 年 9 月 20 日期间 7 天至 59 个月儿童的全因死亡率，称为评估期。该试验进行了前瞻性注册 （ISRCTN 39213655），并且方案已经发布。结果： 我们在基线时招募了 3800 种化合物，其中 12 893 名儿童为主要结局的分析做出了贡献 （干预组 12 893 名中的 7316 名 [56·8%]，对照组 5577 名 [43·3%]）。12 893 名儿童中有 6617 名 （51·3%） 为男性，6275 名 （48·7%） 为女性，1 名 （<0·1%） 儿童的性别数据缺失。采样化合物随机来自 32 个集群中 425 个村庄中的 388 个 （91·3%）。我们对 1182 例死亡进行了口头尸检，其中 369 例 （31·2%） 是评估期间 7 天至 59 个月的儿童。在这 369 例中，91 例 （24·7%） 被归类为肺炎死亡。儿童在分析中贡献了 361 天 （IQR 236-365），其中 12 893 名儿童中有 369 名 （2·9%） 在死亡日期被审查，1545 名 （12·0%） 在他们 5 岁生日时被审查，3392 名 （26·3%） 在最近一次已知其居住或生存状况的随访日期被审查。我们发现干预组的全因死亡率 （风险比 0·95， 95% CI 0·68-1·33;p=0·79） 或疑似肺炎死亡率 （0·79， 0·43-1·46;p=0·46） 没有显著降低。过程评估显示干预覆盖率低且存在问题，但定性数据强调了对健康和人际关系产生积极影响的机制。解释 我们的干预对死亡率没有影响。 然而，由于该地区的儿童死亡率很高，应该进一步努力调整我们的参与式全系统方法，以在化合物中使用行动社区。资助 GSK 和英国救助儿童会。翻译 有关摘要的豪萨语翻译，请参见补充材料部分。