Effect of Donor Milk on Severe Infections and Mortality in Very Low-Birth-Weight Infants The Early Nutrition Study Randomized Clinical Trial
Effect of Donor Milk on Severe Infections and Mortality in Very Low-Birth-Weight Infants The Early Nutrition Study Randomized Clinical Trial
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DOI：
10.1001/jamapediatrics.2016.0183
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发表时间：
2016-07-01
期刊：
影响因子：
26.1
通讯作者：
van Zoeren-Grobben, Diny
中科院分区：
文献类型：
--
作者：
Corpeleijn, Willemijn E.;de Waard, Marita;van Zoeren-Grobben, Diny
感染和坏死性小肠结肠炎是早产儿死亡和发病的主要原因，与配方奶粉相比，母乳喂养的婴儿感染和坏死性小肠结肠炎的发生率降低。当自己的母乳无法获得时，人类捐赠的母乳被认为是一个很好的替代品，尽管价格昂贵。然而，现代新生儿重症监护病房的大多数婴儿主要用自己的母乳喂养。添加母乳的益处尚不清楚。目的：确定在出生后10天内，当母乳不足时，提供母乳替代配方奶粉作为补充喂养是否能降低严重感染、坏死性小肠结肠炎和死亡率的发生率。在2012年3月30日至2014年8月17日期间在荷兰6个新生儿重症监护病房之一住院的极低出生体重儿（出生体重< 1500 g）中进行的双盲随机临床试验。干预婴儿在出生后的前10天接受巴氏消毒的捐赠者牛奶或早产儿配方奶粉，如果自己母亲的牛奶没有主要结果和指标主要终点是严重感染的累积发生率（败血症或脑膜炎），坏死性小肠结肠炎，或死亡率在前60天的生活。排除了557名婴儿，得到了373名婴儿（183名接受捐赠母乳，190名接受配方奶粉），他们通过意向治疗分析进行了评估（中位出生体重，1066 g;平均胎龄，28.4周）。在干预期间，母乳和配方奶粉组的母乳分别占总平均摄入量的89.1%和84.5%。合并结局的发生率无差异（85 [44.7%] [配方奶] vs 77 [42.1%] [供体奶];平均差异，2.6%; 95% CI，-12.7%至7.4%）。调整后的风险比为0.87（95%CI，0.63-1.19; P = 0.37）。结论和相关性在当前研究中，巴氏灭菌的捐赠牛奶和早产儿配方奶粉作为生命最初10天的补充喂养，在极低出生体重婴儿中产生了类似的短期结果。当自己的母乳供应不足时，婴儿的安全性和有效性。未来的研究调查更长时间的使用人类供体母乳的短期和长期结果是必要的。
IMPORTANCE Infections and necrotizing enterocolitis, major causes of mortality and morbidity in preterm infants, are reduced in infants fed their own mother's milk when compared with formula. When own mother's milk is not available, human donor milk is considered a good alternative, albeit an expensive one. However, most infants at modern neonatal intensive care units are predominantly fed with own mother's milk. The benefits of add-on donor milk over formula are not clear.OBJECTIVE To determine whether providing donor milk instead of formula as supplemental feeding whenever own mother's milk is insufficiently available during the first 10 days of life reduces the incidence of serious infection, necrotizing enterocolitis, and mortality.DESIGN, SETTINGS, AND PARTICIPANTS The Early Nutrition Studywas a multicenter, double-blind randomized clinical trial in very low-birth-weight infants (birth weight < 1500 g) admitted to 1 of 6 neonatal intensive care units in the Netherlands from March 30, 2012, through August 17, 2014. Intent-to-treat analysis was performed.INTERVENTIONS Infants received pasteurized donor milk or preterm formula during the first 10 days of life if own mother's milk was not (sufficiently) available.MAIN OUTCOMES AND MEASURES The primary end point was cumulative occurrence of serious infection (sepsis or meningitis), necrotizing enterocolitis, or mortality during the first 60 days of life.RESULTS A total of 930 infants were screened for inclusion; 557 were excluded, resulting in 373 infants (183 receiving donor milk and 190 receiving formula) who were evaluated by intent-to-treat analysis (median birth weight, 1066 g; mean gestational age, 28.4 weeks). Own mother's milk comprised 89.1% and 84.5% of total mean intake during the intervention period for the donor milk and formula groups, respectively. The incidence of the combined outcome was not different (85 [44.7%] [formula] vs 77 [42.1%] [donor milk]; mean difference, 2.6%; 95% CI, -12.7% to 7.4%). The adjusted hazard ratio was 0.87 (95% CI, 0.63-1.19; P =.37).CONCLUSIONS AND RELEVANCE In the current study, pasteurized donor milk and preterm formula as supplemental feeding during the first 10 days of life yielded similar short-term outcomes in very low-birth-weight infants regarding safety and efficacy when own mother's milk availability was insufficient. Future studies investigating longer duration of use of human donor milk on short-term and long-term outcomes are necessary.