Peng Rong, Li Hailong, Yang Lijun, Chen Xinwei, Zeng Linan, Bo Zhenyan, Zhang Lingli
Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, China.
Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, China.
BMJ Open. 2020 Sep 3;10(9):e037014. doi: 10.1136/bmjopen-2020-037014.
Traumatic brain injury (TBI) is the leading cause of paediatric trauma death and disability worldwide. The 'Guidelines for the Management of Severe Traumatic Brain Injury (Fourth Edition)' recommend that nutritional goals should be achieved within 5-7 days of injury. Immune-enhancing nutrition or immunonutrition, referring to the addition of specialised nutrients, including glutamine, alanine, omega-3 fatty acids and nucleotides, to standard nutrition formulas, may improve surgical outcomes in the perioperative period. However, the role of immune-enhancing nutritional supplements for patients with paediatric TBI remains unclear. We will conduct a systematic review to determine the efficacy and safety of immunonutrition for patients with paediatric TBI and provide evidence for clinical decision-making.
Studies reporting immune-enhancing nutrition treatments for patients with paediatric TBI will be included. Outcomes of interest include the length of hospital stay, wound infections, all-cause mortality, non-wound infection, including pneumonia, urinary tract infection and bacteraemia, and the reports adverse events. Duration of follow-up has no restriction. Primary studies consisting of randomised controlled trials (RCTs) and non-RCTs will be eligible for this review, and only studies published in English will be included. We will search the Medline, Embase and Cochrane Library databases from their inception dates to January 2020. We will also search clinicaltrials.gov and the WHO International Clinical Trials Registry Platform for additional information. Two reviewers will independently select studies and extract data. Risk-of-bias will be assessed with tools based on the Cochrane risk-of-bias criteria and Newcastle-Ottawa Quality Assessment Scale. A meta-analysis will be used to pool data when there are sufficient studies with homogeneity. Heterogeneity of the estimates across studies will be assessed; if necessary, a subgroup analysis will be performed to explore the source of heterogeneity. The Grades of Recommendation, Assessment, Development and Evaluation method will be applied to assess the level of evidence obtained from this systematic review.
The proposed systematic review and meta-analysis will be based on published data, and thus ethical approval is not required. The results of this review will be published.
CRD42020154814.
创伤性脑损伤（TBI）是全球儿童创伤死亡和残疾的主要原因。《严重创伤性脑损伤管理指南（第四版）》建议应在受伤后5 - 7天内实现营养目标。免疫增强营养或免疫营养是指在标准营养配方中添加包括谷氨酰胺、丙氨酸、ω-3脂肪酸和核苷酸在内的特殊营养素，可能会改善围手术期的手术效果。然而，免疫增强营养补充剂对小儿TBI患者的作用仍不明确。我们将进行一项系统评价，以确定免疫营养对小儿TBI患者的疗效和安全性，并为临床决策提供证据。
将纳入报告小儿TBI患者免疫增强营养治疗的研究。感兴趣的结局包括住院时间、伤口感染、全因死亡率、非伤口感染（包括肺炎、尿路感染和菌血症）以及不良事件报告。随访时间无限制。由随机对照试验（RCT）和非RCT组成的原始研究将符合本评价的条件，且仅纳入以英文发表的研究。我们将检索Medline、Embase和Cochrane图书馆数据库，从其创建日期至2020年1月。我们还将检索clinicaltrials.gov和世界卫生组织国际临床试验注册平台以获取更多信息。两名评价者将独立选择研究并提取数据。将使用基于Cochrane偏倚风险标准和纽卡斯尔-渥太华质量评估量表的工具评估偏倚风险。当有足够数量的同质性研究时，将使用荟萃分析来汇总数据。将评估各研究估计值的异质性；如有必要，将进行亚组分析以探索异质性来源。将应用推荐分级、评估、制定与评价方法来评估从该系统评价中获得的证据水平。
拟进行的系统评价和荟萃分析将基于已发表的数据，因此无需伦理批准。本评价的结果将予以发表。
PROSPERO注册号：CRD420201
