Klotz Daniel, Bzikowska-Jura Agnieszka, Giribaldi Marzia, Cassidy Tanya, Cavallarin Laura, Gandino Serena, Karcz Karolina, Peila Chiara, Smith Carolyn, Walczak Bartłomiej, Wesolowska Aleksandra
Bethel Center for Pediatrics, Department of Neonatology and Pediatric Intensive Care, University Hospital OWL, University of Bielefeld, Bielefeld, Germany.
Laboratory of Human Milk and Lactation Research, Department of Medical Biology, Medical University of Warsaw, Warsaw, Poland.
BMJ Open. 2024 Dec 27;14(12):e087653. doi: 10.1136/bmjopen-2024-087653.
Donor human milk (DHM) is the first alternative if mother's own milk is unavailable or contraindicated. Much DHM research has focused on its nutritional, immunological and biochemical composition in response to various maternal variables, standard human milk banking procedures and storage protocols. The current systematic review protocol, however, aims to systematically gather and analyse existing data pertaining to the impact of these aforementioned factors on the clinical, health-related and developmental outcomes observed in infants fed with DHM.
We will apply a predefined search strategy including Cochrane Central Register of Controlled Trials, Global Index Medicus, CINAHL on Ebscohost, Medline, Embase, Emcare, Pubmed, Global Health on OVID, Google Scholar, clinicaltrials.gov, the WHO International Trials Registry and Platform and the European Union/European Economic Area Clinical Trials Register. No setting, patient population, date or language restrictions will be applied. The search strategy will consist of search words on the key concepts of 'donated human milk' and 'effect on infants'. Published or unpublished primary research studies are eligible for inclusion if there is an abstract available in English. Conference proceedings, animal studies and publications with no original data will be excluded.Authors of unpublished or partially published studies will be contacted and eligible data added if provided. Risk of bias will be evaluated according to CASP using appropriate tools depending on study type (RoB 2, ROBINS-I, Newcastle Ottawa Scale). Data will be synthesised in a quantitative format describing significant results as well as presenting the results of the quality assessment of studies.
This systematic review does not require ethical approval, as we will not collect primary data. The review will be published in a peer-reviewed journal and disseminated electronically and in print.
CRD42024522015.
如果无法获得或不宜使用母亲自己的母乳，捐赠人乳（DHM）是首选替代品。许多关于DHM的研究都集中在其营养、免疫和生化成分上，以应对各种母亲变量、标准人乳库程序和储存方案。然而，本系统评价方案旨在系统收集和分析现有数据，这些数据涉及上述因素对食用DHM的婴儿的临床、健康相关和发育结局的影响。
我们将应用预定义的检索策略，包括Cochrane对照试验中心注册库、全球医学索引、Ebscohost上的护理学与健康领域数据库、医学索引、荷兰医学文摘数据库、循证医学数据库、PubMed、OVID上的全球健康数据库、谷歌学术、临床研究数据库、世界卫生组织国际临床试验注册平台以及欧盟/欧洲经济区临床试验注册库。不设研究背景、患者群体、日期或语言限制。检索策略将包括关于“捐赠人乳”和“对婴儿的影响”等关键概念的检索词。如果有英文摘要，已发表或未发表的原始研究均符合纳入标准。会议论文集、动物研究和无原始数据的出版物将被排除。将联系未发表或部分发表研究的作者，若能提供符合条件的数据则予以补充。将根据CASP，使用适用于研究类型的适当工具（RoB 2、ROBINS-I、纽卡斯尔-渥太华量表）评估偏倚风险。数据将以定量形式进行综合，描述显著结果并呈现研究质量评估结果。
本系统评价无需伦理批准，因为我们不会收集原始数据。该评价将发表在同行评审期刊上，并以电子和印刷形式传播。
PROSPERO注册号：CRD42024522015。
