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.)

中文翻译：

---

早产儿两种递增奶喂养率的对照试验

背景

观察数据表明，早产儿肠内喂养量的缓慢增加与坏死性小肠结肠炎的风险降低有关，但与迟发性败血症的风险增加有关。但是，来自随机试验的数据有限。

方法

我们随机分配极早产或极低出生体重的婴儿，以每公斤体重30毫升（较快的增量）或18公斤每千克（较慢的增量）的每日牛奶增量，直到达到全喂食量。主要结局是在24个月时无中度或严重神经发育障碍的生存。次要结局包括主要结局，确诊或怀疑的迟发性败血症，坏死性小肠结肠炎和脑瘫的组成部分。

结果

在接受随机分组的2804例婴儿中，主要结局可以评估为1224（87.4％）的较快增长者和1246（88.7％）的较慢的增长者。在12个月内没有发生中度或重度神经发育障碍的幸存者发生在1224例婴儿中，其中802例（65.5％）被分配为较快的增量，而1246例婴儿中的848（68.1％）被分配为较慢的增量（校正后的风险比，0.96； 95％的置信区间[ CI]，0.92至1.01； P = 0.16）。较快增加组的1389例婴儿中有414例（29.8％）发生了迟发性败血症，较慢度增加组的434例中有1397例婴儿（31.1％）中发生了败血症（调整后的风险比为0.96； 95％CI为0.86-1.07）。快增组的1394例婴儿中有70例坏死性小肠结肠炎（5.0％），慢增组的1399例婴儿中有78例（399％（5.6％）（调整后的风险比为0.88; 95％CI为0）。

结论

对于极早产或极低出生体重的婴儿，在24个月内没有中度或重度神经发育障碍的生存率方面，无显着差异，其策略是每天每公斤增加30 ml牛奶的喂养策略，而每公斤每天增加18 ml公斤。（由美国国立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。）