Controlled Trial of Two Incremental Milk-Feeding Rates in Preterm Infants
Controlled Trial of Two Incremental Milk-Feeding Rates in Preterm Infants
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DOI：
10.1056/nejmoa1816654
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发表时间：
2019-10-10
影响因子：
158.5
通讯作者：
Townend, John
中科院分区：
文献类型：
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作者：
Dorling, Jon;Abbott, Jane;Townend, John
背景：观察数据显示，早产儿肠内喂养量的缓慢推进与坏死性小肠结肠炎的风险降低有关，但却增加了迟发性败血症的风险。然而，随机试验的数据是有限的。方法：我们随机分配极早产儿或极低出生体重婴儿，每天以每公斤体重30毫升（较快增量）或每公斤18毫升（较慢增量）的方式增加母乳量，直到达到完全喂养量。主要终点是24个月时无中度或重度神经发育障碍的生存。次要结局包括主要结局的组成部分，确诊或疑似迟发性败血症、坏死性小肠结肠炎和脑瘫。在接受随机分组的2804名婴儿中，1224名（87.4%）被分配到较快增量组，1246名（88.7%）被分配到较慢增量组，主要结局可以评估。1224名婴儿中802名（65.5%）在24个月时无中度或重度神经发育障碍，1246名婴儿中848名（68.1%）在24个月时无中度或重度神经发育障碍（校正风险比为0.96；95%可信区间[CI]， 0.92至1.01；P=0.16）。1389名婴儿中，快速增长组有414名（29.8%）发生迟发性脓毒症，而缓慢增长组有434名（31.1%）发生迟发性脓毒症（校正风险比为0.96；95% CI为0.86 ~ 1.07）。1394例婴儿中，快速增长组有70例（5.0%）发生坏死性小肠结肠炎，而缓慢增长组有78例（5.6%）发生坏死性小肠结肠炎（校正风险比0.88;95% CI, 0.68 ~ 1.16）。结论：极早产儿或极低出生体重婴儿在24月龄无中度或重度神经发育障碍的生存率方面，采用每日增加30毫升/千克母乳喂养的策略与每日增加18毫升/千克母乳喂养的策略没有显著差异。（由国家卫生研究院卫生技术评估计划资助；SIFT当前对照试验编号，ISRCTN76463425。）在这项涉及极早产或极低出生体重婴儿的随机试验中，24个月时无中度或重度神经发育障碍的生存率与每公斤体重每天增加30毫升母乳喂养量的策略没有显著差异，而每公斤体重增加18毫升。
Background Observational data have shown that slow advancement of enteral feeding volumes in preterm infants is associated with a reduced risk of necrotizing enterocolitis but an increased risk of late-onset sepsis. However, data from randomized trials are limited. Methods We randomly assigned very preterm or very-low-birth-weight infants to daily milk increments of 30 ml per kilogram of body weight (faster increment) or 18 ml per kilogram (slower increment) until reaching full feeding volumes. The primary outcome was survival without moderate or severe neurodevelopmental disability at 24 months. Secondary outcomes included components of the primary outcome, confirmed or suspected late-onset sepsis, necrotizing enterocolitis, and cerebral palsy. Results Among 2804 infants who underwent randomization, the primary outcome could be assessed in 1224 (87.4%) assigned to the faster increment and 1246 (88.7%) assigned to the slower increment. Survival without moderate or severe neurodevelopmental disability at 24 months occurred in 802 of 1224 infants (65.5%) assigned to the faster increment and 848 of 1246 (68.1%) assigned to the slower increment (adjusted risk ratio, 0.96; 95% confidence interval [CI], 0.92 to 1.01; P=0.16). Late-onset sepsis occurred in 414 of 1389 infants (29.8%) in the faster-increment group and 434 of 1397 (31.1%) in the slower-increment group (adjusted risk ratio, 0.96; 95% CI, 0.86 to 1.07). Necrotizing enterocolitis occurred in 70 of 1394 infants (5.0%) in the faster-increment group and 78 of 1399 (5.6%) in the slower-increment group (adjusted risk ratio, 0.88; 95% CI, 0.68 to 1.16). Conclusions There was no significant difference in survival without moderate or severe neurodevelopmental disability at 24 months in very preterm or very-low-birth-weight infants with a strategy of advancing milk feeding volumes in daily increments of 30 ml per kilogram as compared with 18 ml per kilogram. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; SIFT Current Controlled Trials number, ISRCTN76463425.)In this randomized trial involving very preterm or very-low-birth-weight infants, there was no significant difference in survival without moderate or severe neurodevelopmental disability at 24 months with a strategy of advancing milk feeding volumes in daily increments of 30 ml per kilogram of body weight as compared with 18 ml per kilogram.