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Abstract：
BACKGROUND: Childhood pneumonia is a leading cause of morbidity and mortality among children aged 2-59 months, particularly in low-income and middle-income countries (LMICs), where healthcare providers face significant challenges in diagnosing and treating childhood pneumonia. Many LMICs have taken steps to address this issue by revising their national policies and aligning them with WHO\'s revised guidelines for pneumonia management. These revised guidelines aim to facilitate the outpatient management of children aged 2-59 months chest indrawing pneumonia. Despite these efforts, there is limited empirical evidence regarding the management and outcomes of these children in primary-level healthcare settings. This study aims to assess the survival status of children aged 2-59 months with chest indrawing pneumonia presenting at primary healthcare facilities.
METHODS: A prospective, observational cohort study will be conducted in Ethiopia, Nigeria, Uganda, Zambia, India and Pakistan on children aged 2-59 months presenting at selected primary-level healthcare facilities with chest indrawing pneumonia. Eligible participants will be enrolled and managed by facility healthcare providers who are trained in Integrated Management of Childhood Illness and will be followed up on day 15 to record the treatment-related information and vital status, including conducting verbal autopsies in case of child death. The sample size for each site will be 310. The analysis will involve exploring site-specific trends before conducting a pooled analysis of de-identified data from all sites. The first data collection started at the Ethiopian site in September 2022, followed by other sites. The data collection will continue until June 2025.
BACKGROUND: The study protocol, enrolment forms and consent forms will undergo ethical review by the Institutional Review Boards of the University of Gondar, Gondar, Ethiopia; the INCLEN Trust International Independent Ethics Committee, New Delhi, India; Ethical Review Committee of the University of Ibadan, Ethical Review Committees of Lagos State and Ethical Review Committee of University College London, UK; Institutional Review Board, International Research Force, Islamabad, Pakistan; Institutional Review Board, People\'s Primary Healthcare Initiative-Sindh, Karachi and National Bioethics Committee, Islamabad, Pakistan; Makerere University School of Biomedical Sciences Research Ethical Committee, Kampala, Uganda; University of Zambia Biomedical Research Ethics committee, Lusaka, Zambia and Ethical Review Committee of WHO, Geneva, Switzerland. Ethical procedures include WHO and local review board evaluations, parental consent in the local/national language, permits enrolment, follow-up, and, if required, clinical video recording for children with chest indrawing pneumonia, ensuring their eligibility. Adherence to local regulations encompasses precollection ethical approvals, risk management strategies and secure, de-identified data storage. Findings will be disseminated through seminars, publications and meetings, engaging diverse stakeholders to foster collaborations.
BACKGROUND: ISRCTN12687253.
METHODS: A prospective, observational cohort study will be conducted in Ethiopia, Nigeria, Uganda, Zambia, India and Pakistan on children aged 2-59 months presenting at selected primary-level healthcare facilities with chest indrawing pneumonia. Eligible participants will be enrolled and managed by facility healthcare providers who are trained in Integrated Management of Childhood Illness and will be followed up on day 15 to record the treatment-related information and vital status, including conducting verbal autopsies in case of child death. The sample size for each site will be 310. The analysis will involve exploring site-specific trends before conducting a pooled analysis of de-identified data from all sites. The first data collection started at the Ethiopian site in September 2022, followed by other sites. The data collection will continue until June 2025.
BACKGROUND: The study protocol, enrolment forms and consent forms will undergo ethical review by the Institutional Review Boards of the University of Gondar, Gondar, Ethiopia; the INCLEN Trust International Independent Ethics Committee, New Delhi, India; Ethical Review Committee of the University of Ibadan, Ethical Review Committees of Lagos State and Ethical Review Committee of University College London, UK; Institutional Review Board, International Research Force, Islamabad, Pakistan; Institutional Review Board, People\'s Primary Healthcare Initiative-Sindh, Karachi and National Bioethics Committee, Islamabad, Pakistan; Makerere University School of Biomedical Sciences Research Ethical Committee, Kampala, Uganda; University of Zambia Biomedical Research Ethics committee, Lusaka, Zambia and Ethical Review Committee of WHO, Geneva, Switzerland. Ethical procedures include WHO and local review board evaluations, parental consent in the local/national language, permits enrolment, follow-up, and, if required, clinical video recording for children with chest indrawing pneumonia, ensuring their eligibility. Adherence to local regulations encompasses precollection ethical approvals, risk management strategies and secure, de-identified data storage. Findings will be disseminated through seminars, publications and meetings, engaging diverse stakeholders to foster collaborations.
BACKGROUND: ISRCTN12687253.
摘要：
背景：儿童肺炎是2-59个月儿童发病和死亡的主要原因，特别是在低收入和中等收入国家(LMICs)，医疗保健提供者在诊断和治疗儿童肺炎方面面临重大挑战。许多低收入国家已采取措施，通过修订其国家政策并使其与世卫组织修订的肺炎管理指南保持一致来解决这一问题。这些修订后的指南旨在促进2-59个月大的胸痛肺炎儿童的门诊管理。尽管做出了这些努力,关于这些儿童在初级卫生保健环境中的管理和结果的经验证据有限.这项研究旨在评估2-59个月大的儿童的生存状况，这些儿童在初级医疗机构出现胸部拉伤肺炎。
方法：前瞻性，观察性队列研究将在埃塞俄比亚进行，尼日利亚,乌干达，赞比亚，印度和巴基斯坦在2-59个月的儿童中，在选定的初级医疗机构中出现胸部拉伤肺炎。符合条件的参与者将由接受过儿童疾病综合管理培训的机构医疗保健提供者注册和管理，并将在第15天进行随访，以记录与治疗相关的信息和生命状况。包括在儿童死亡的情况下进行口头尸检。每个站点的样本大小将是310。分析将涉及在对所有站点的去识别数据进行汇总分析之前，探索特定站点的趋势。首次数据收集于2022年9月在埃塞俄比亚站点开始，随后是其他站点。数据收集将持续到2025年6月。
背景：研究方案，入学表格和同意书将由冈达尔大学的机构审查委员会进行道德审查，Gondar,埃塞俄比亚；INCLEN信托国际独立道德委员会，新德里,印度；伊巴丹大学伦理审查委员会，拉各斯州伦理审查委员会和伦敦大学学院伦理审查委员会，英国；机构审查委员会，国际研究力量,伊斯兰堡,巴基斯坦；机构审查委员会，人民初级保健倡议-信德省，卡拉奇和国家生物伦理委员会，伊斯兰堡,巴基斯坦；马凯雷雷大学生物医学科学院研究伦理委员会，坎帕拉,乌干达；赞比亚大学生物医学研究伦理委员会，卢萨卡,赞比亚和世卫组织伦理审查委员会，日内瓦瑞士。伦理程序包括世卫组织和地方审查委员会的评估，使用当地/国家语言的父母同意，许可证登记，后续行动,and,如果需要,临床视频记录儿童拉胸肺炎，确保他们的资格。遵守当地法规包括预先收集道德批准，风险管理策略和安全，去识别的数据存储。调查结果将通过研讨会传播，出版物和会议，让不同的利益相关者参与促进合作。
背景：ISRCTN12687253。
方法：前瞻性，观察性队列研究将在埃塞俄比亚进行，尼日利亚,乌干达，赞比亚，印度和巴基斯坦在2-59个月的儿童中，在选定的初级医疗机构中出现胸部拉伤肺炎。符合条件的参与者将由接受过儿童疾病综合管理培训的机构医疗保健提供者注册和管理，并将在第15天进行随访，以记录与治疗相关的信息和生命状况。包括在儿童死亡的情况下进行口头尸检。每个站点的样本大小将是310。分析将涉及在对所有站点的去识别数据进行汇总分析之前，探索特定站点的趋势。首次数据收集于2022年9月在埃塞俄比亚站点开始，随后是其他站点。数据收集将持续到2025年6月。
背景：研究方案，入学表格和同意书将由冈达尔大学的机构审查委员会进行道德审查，Gondar,埃塞俄比亚；INCLEN信托国际独立道德委员会，新德里,印度；伊巴丹大学伦理审查委员会，拉各斯州伦理审查委员会和伦敦大学学院伦理审查委员会，英国；机构审查委员会，国际研究力量,伊斯兰堡,巴基斯坦；机构审查委员会，人民初级保健倡议-信德省，卡拉奇和国家生物伦理委员会，伊斯兰堡,巴基斯坦；马凯雷雷大学生物医学科学院研究伦理委员会，坎帕拉,乌干达；赞比亚大学生物医学研究伦理委员会，卢萨卡,赞比亚和世卫组织伦理审查委员会，日内瓦瑞士。伦理程序包括世卫组织和地方审查委员会的评估，使用当地/国家语言的父母同意，许可证登记，后续行动,and,如果需要,临床视频记录儿童拉胸肺炎，确保他们的资格。遵守当地法规包括预先收集道德批准，风险管理策略和安全，去识别的数据存储。调查结果将通过研讨会传播，出版物和会议，让不同的利益相关者参与促进合作。
背景：ISRCTN12687253。
