BACKGROUND Sepsis is a major cause of morbidity and mortality among neonates and infants. Antibiotics are a central part of the first line treatment for sepsis in neonatal intensive care units worldwide. However, the evidence on the clinical effects of the commonly used antibiotic regimens for sepsis in neonates remains scarce. This systematic review aims to assess the efficacy and harms of antibiotic regimens for neonatal sepsis. METHODS Electronic searches will be conducted in MEDLINE, Embase, The Cochrane Library, CINAHL, ZETOC and clinical trial registries (clinicaltrials.gov and ISRCTN). We will include randomised controlled trials of different antibiotic regimens for sepsis of neonates and infants. Eligible interventions will be any antibiotic regimen. Two reviewers will independently screen, select, and extract data. The methodological quality of individual studies will be appraised following Cochrane methodology. Primary outcomes will be 'all-cause mortality' and 'serious adverse events'. Secondary outcomes will be 'need for respiratory support', 'need for circulatory support', 'neurodevelopmental impairment', ototoxicity, nephrotoxicity and necrotizing enterocolitis. We plan to perform a meta-analysis with trial sequential analysis. DISCUSSION This is the study protocol for a systematic review on the effects of different antibiotic regimens for neonatal sepsis. The results of this systematic review intent to adequately inform stakeholders or health care professionals in the field of neonatal sepsis, and to aid appropriate development of treatment guidelines. SYSTEMATIC REVIEW REGISTRATION PROSPERO reference number: CRD42019134300.

中文翻译：

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新生儿败血症的抗生素治疗方案-一项通过荟萃分析进行系统回顾的方案。

背景技术败血症是新生儿和婴儿中发病和死亡的主要原因。抗生素是全球新生儿重症监护病房败血症一线治疗的核心部分。然而，关于新生儿败血症常用抗生素治疗方案临床效果的证据仍然很少。该系统评价旨在评估抗生素治疗新生儿败血症的功效和危害。方法电子检索将在MEDLINE，Embase，Cochrane图书馆，CINAHL，ZETOC和临床试验注册中心（clinicaltrials.gov和ISRCTN）中进行。我们将包括针对新生儿和婴儿败血症的不同抗生素治疗方案的随机对照试验。合格的干预措施可以是任何抗生素治疗方案。两名审阅者将独立筛选，选择和提取数据。个别研究的方法学质量将按照Cochrane方法论进行评估。主要结果将是“全因死亡率”和“严重不良事件”。次要结果是“需要呼吸支持”，“需要循环支持”，“神经发育障碍”，耳毒性，肾毒性和坏死性小肠结肠炎。我们计划通过试验顺序分析进行荟萃分析。讨论这是用于系统评估不同抗生素方案对新生儿败血症影响的研究方案。该系统评价的结果旨在为新生儿败血症领域的利益相关者或卫生保健专业人员提供充分的信息，并帮助适当制定治疗指南。系统审核注册PROSPERO参考编号：