Department of Neonatology, Children's Hospital affiliated to Zhengzhou University, Henan Children's Hospital, Zhengzhou Children's Hospital, 33 Longhuwaihuan Road, Zhengzhou, 450018, Henan, China.
Department of Neonatology, Children's Hospital of Fudan University, 399 Wanyuan Road, Minhang District, Shanghai, 201102, Shanghai, China.
Trials. 2020 Feb 11;21(1):170. doi: 10.1186/s13063-019-3981-4.
BACKGROUND: Necrotizing enterocolitis (NEC) is the leading cause of death among preterm infants born at < 30 weeks' gestation. The incidence of NEC is reduced when infants are fed human milk. However, in many neonatal intensive care units (NICUs), it is standard practice to freeze and/or pasteurize human milk, which deactivates bioactive components that may offer additional protective benefits. Indeed, our pilot study showed that one feed of fresh mother's own milk per day was safe, feasible, and can reduce morbidity in preterm infants. To further evaluate the benefits of fresh human milk in the NICU, a randomized controlled trial is needed. METHODS: Our prospective multicenter, double-blinded, randomized, controlled trial will include infants born at < 30 weeks' gestation and admitted to one of 29 tertiary NICUs in China. Infants in the intervention (fresh human milk) group (n = 1549) will receive at least two feeds of fresh human milk (i.e., within 4 h of expression) per day from the time of enrollment until 32 weeks' corrected age or discharge to home. Infants in the control group (n = 1549) will receive previously frozen human milk following the current standard protocols. Following informed consent, enrolled infants will be randomly allocated to the control or fresh human milk groups. The primary outcome is the composite outcome mortality or NEC ≥ stage 2 at 32 weeks' corrected age, and the secondary outcomes are mortality, NEC ≥ stage 2, NEC needing surgery, late-onset sepsis, retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), weight gain, change in weight, increase in length, increase in head circumference, time to full enteral feeds, and finally, the number and type of critical incident reports, including feeding errors. DISCUSSION: Our double-blinded, randomized, controlled trial aims to examine whether fresh human milk can improve infant outcomes. The results of this study will impact both Chinese and international medical practice and feeding policy for preterm infants. In addition, data from our study will inform changes in health policy in NICUs across China, such that mothers are encouraged to enter the NICU and express fresh milk for their infants. TRIAL REGISTRATION: Chinese Clinical Trial Registry; #ChiCTR1900020577; registered January 1, 2019; http://www.chictr.org.cn/showprojen.aspx?proj=34276.
背景：坏死性小肠结肠炎（NEC）是 <30 周早产儿死亡的主要原因。用母乳喂养可以降低 NEC 的发病率。然而，在许多新生儿重症监护病房（NICU），冷冻和/或巴氏消毒母乳是标准做法，这会使可能提供额外保护益处的生物活性成分失活。事实上，我们的初步研究表明，每天喂养一次新鲜的母亲自己的母乳是安全、可行的，可以降低早产儿的发病率。为了进一步评估新鲜母乳在 NICU 中的益处，需要进行一项随机对照试验。
方法：我们的前瞻性多中心、双盲、随机、对照试验将纳入在中国 29 家三级 NICU 住院的 <30 周早产儿。干预组（新鲜母乳）（n=1549）的婴儿将从入组时开始每天至少接受两次新鲜母乳（即，在挤出后 4 小时内），持续到校正年龄 32 周或出院回家。对照组（n=1549）的婴儿将按照目前的标准方案接受之前冷冻的母乳。在获得知情同意后，入组的婴儿将被随机分配到对照组或新鲜母乳组。主要结局是复合结局死亡率或校正 32 周龄时 NEC≥2 期，次要结局是死亡率、NEC≥2 期、NEC 需要手术、晚发性败血症、早产儿视网膜病变（ROP）、支气管肺发育不良（BPD）、体重增加、体重变化、身长增加、头围增加、完全肠内喂养时间，最后是危急事件报告的数量和类型，包括喂养错误。
讨论：我们的双盲、随机、对照试验旨在研究新鲜母乳是否能改善婴儿的结局。该研究的结果将影响中国和国际的医疗实践和早产儿喂养政策。此外，我们研究的数据将为中国各地 NICU 的卫生政策提供信息，鼓励母亲进入 NICU 为她们的婴儿表达新鲜母乳。
试验注册：中国临床试验注册中心；#ChiCTR1900020577；注册于 2019 年 1 月 1 日；http://www.chictr.org.cn/showprojen.aspx?proj=34276。
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