Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
Department of Paediatrics, Linköping University, Linköping, Östergötland, Sweden.
BMJ Open. 2021 Nov 23;11(11):e053400. doi: 10.1136/bmjopen-2021-053400.
The mortality rate of extremely low gestational age (ELGA) (born <gestational week 28+0) infants remains high, and severe infections and necrotising enterocolitis (NEC) are common causes of death. Preterm infants receiving human milk have lower incidence of sepsis and NEC than those fed a bovine milk-based preterm formula. Despite this, fully human milk fed ELGA infants most often have a significant intake of cow's milk protein from bovine-based protein fortifier. The aim of this study is to evaluate whether the supplementation of human milk-based, as compared with bovine-based, nutrient fortifier reduces the prevalence of NEC, sepsis and mortality in ELGA infants exclusively fed with human milk.
A randomised-controlled multicentre trial comparing the effect of a human breast milk-based fortifier with a standard bovine protein-based fortifier in 222-322 ELGA infants fed human breast milk (mother's own milk and/or donor milk). The infants will be randomised to either fortifier before reaching 100 mL/kg/day in oral feeds. The intervention, stratified by centre, will continue until the target postmenstrual week 34+0. The primary outcome is a composite of NEC, sepsis or death. Infants are characterised with comprehensive clinical and nutritional data collected prospectively from birth until hospital discharge. Stool, urine, blood and breast milk samples are collected for analyses in order to study underlying mechanisms. A follow-up focusing on neurological development and growth will be performed at 2 and 5.5 years of age. Health economic analyses will be made.
The study is conducted according to ICH/GCP guidelines and is approved by the regional ethical review board in Linköping Sweden (Dnr 2018/193-31, Dnr 2018/384-32). Results will be presented at scientific meetings and published in peer-reviewed publications.
The study was registered with ClinicalTrials.gov NCT03797157, 9 January 2019.
极低胎龄（ELGA）（出生<28+0 周）婴儿的死亡率仍然很高，严重感染和坏死性小肠结肠炎（NEC）是常见的死亡原因。接受人乳喂养的早产儿比接受牛乳制品早产儿配方奶粉喂养的早产儿发生败血症和 NEC 的发生率更低。尽管如此，大多数接受全人乳喂养的 ELGA 婴儿通常会从基于牛的蛋白质强化剂中摄入大量牛乳蛋白。本研究旨在评估与基于牛的营养素强化剂相比，人乳基强化剂是否可降低完全接受人乳喂养的 ELGA 婴儿 NEC、败血症和死亡率的发生率。
这是一项比较 222-322 名接受人乳（母亲自身的乳汁和/或捐赠的乳汁）喂养的 ELGA 婴儿使用人乳基强化剂与标准牛蛋白基强化剂效果的随机对照多中心试验。婴儿将在达到 100 毫升/千克/天口服喂养量之前随机分配到强化剂组。干预措施按中心分层，将持续到目标孕龄 34+0 周。主要结局是 NEC、败血症或死亡的复合结局。婴儿的临床和营养数据从出生到出院将进行前瞻性收集和描述。收集粪便、尿液、血液和母乳样本进行分析，以研究潜在机制。在 2 岁和 5.5 岁时将进行关注神经发育和生长的随访。将进行健康经济学分析。
该研究按照 ICH/GCP 指南进行，并获得了瑞典林雪平地区伦理审查委员会的批准（编号 2018/193-31，编号 2018/384-32）。研究结果将在科学会议上进行报告，并发表在同行评议的出版物中。
该研究于 2019 年 1 月 9 日在 ClinicalTrials.gov 上注册，编号为 NCT03797157。
