Efficacy of zinc supplementation for young infants with clinical severe infection in Tanzania: study protocol for a randomised controlled trial.

IF 2.3 4区 医学 Q2 PEDIATRICS
Karim P Manji, Sarah Somji, Mohamed Bakari, Wafaie W Fawzi, Upendo Kibwana, Rodrick Kisenge, Abuu S Kisumuni, Enju Liu, Neema Mafie, Fredrick A Maleko, Nahya Salim, Christopher P Duggan, Christopher R Sudfeld
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Abstract

Introduction: Innovative interventions will be essential for countries in sub-Saharan Africa to achieve the 2030 Sustainable Development Goal for child mortality. Infections among young infants, including sepsis, meningitis and pneumonia, continue to cause a large burden of morbidity and mortality in low-income and middle-income countries. Zinc is an essential micronutrient with a well-established role in human health and immune system function, and supplementation may improve survival and treatment outcomes for infants with bacterial infections.

Methods and analysis: We will conduct an individually randomised, quadruple-blind trial of zinc supplementation among 3250 infants 0-59 days old with clinical severe infection (CSI) in Dar es Salaam, Tanzania. Infants with CSI will be randomised to receive either (1) zinc citrate supplementation consisting of 5 mg elemental zinc taken two times per day for 14 days or (2) a matching placebo supplementation taken two times per day for 14 days. Infants will be followed for 90 days postrandomisation. The coprimary outcomes are (1) infant death (all-cause mortality to 90 days) and (2) treatment failure (composite outcome of death during initial hospitalisation, need for additional respiratory support, use of vasoactive medicines or change of antibiotics). Secondary outcomes include important infant health and nutritional outcomes.

Ethics and dissemination: The trial protocol was approved by Harvard T. H. Chan School of Public Health Institutional Review Board, the Muhimbili University of Health and Allied Sciences Institutional Review Board, the National Health Research Ethics Sub-Committee and the Tanzania Medicine and Medical Device Authority. Findings will be disseminated locally, regionally and internationally at scientific conference presentations and as peer-reviewed publications.

Trial registration number: NCT06102044; ClinicalTrials.gov identifier.

Abstract Image

补充锌对坦桑尼亚临床严重感染婴儿的疗效:一项随机对照试验的研究方案。
导言:创新干预措施对于撒哈拉以南非洲国家实现关于儿童死亡率的2030年可持续发展目标至关重要。在低收入和中等收入国家,包括败血症、脑膜炎和肺炎在内的幼儿感染继续造成很大的发病率和死亡率负担。锌是一种必需的微量营养素,在人体健康和免疫系统功能中发挥着重要作用,补充锌可以提高细菌感染婴儿的存活率和治疗效果。方法和分析:我们将在坦桑尼亚达累斯萨拉姆的3250名0-59天大的临床严重感染(CSI)婴儿中进行一项单独随机、四盲的锌补充试验。患有CSI的婴儿将被随机分配接受(1)柠檬酸锌补充剂,包括5毫克元素锌,每天服用两次,持续14天;或(2)安慰剂补充剂,每天服用两次,持续14天。这些婴儿将在随机化后随访90天。主要结局是(1)婴儿死亡(90天内的全因死亡率)和(2)治疗失败(最初住院期间死亡、需要额外呼吸支持、使用血管活性药物或更换抗生素的综合结局)。次要结局包括重要的婴儿健康和营养结局。伦理和传播:试验方案得到了哈佛大学陈曾熙公共卫生学院机构审查委员会、Muhimbili卫生和联合科学大学机构审查委员会、国家卫生研究伦理小组委员会和坦桑尼亚医药和医疗器械管理局的批准。研究结果将在当地、区域和国际上以科学会议发言和同行评议出版物的形式传播。试验注册号:NCT06102044;ClinicalTrials.gov标识符。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BMJ Paediatrics Open
BMJ Paediatrics Open Medicine-Pediatrics, Perinatology and Child Health
CiteScore
4.10
自引率
3.80%
发文量
124
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