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中重度早产儿的营养支持 - 一项随机试验。

Nutritional Support for Moderate-to-Late-Preterm Infants - A Randomized Trial.

机构信息

From Liggins Institute (T.A., S.A., J.E.H., M. Muelbert, F.H.B.), the Department of Statistics, Faculty of Science (Y.J.), and the Department of Paediatrics, Child and Youth Health (J.M.A.), University of Auckland, and the Neonatal Unit, Kidz First, Middlemore Hospital, Te Whatu Ora Counties Manukau (T.A., M. Meyer), Auckland, and Newborn Services, Starship Child Health, Te Toka Tumai Auckland, Te Whatu Ora (J.M.A.) - all in New Zealand.

出版信息

N Engl J Med. 2024 Apr 25;390(16):1493-1504. doi: 10.1056/NEJMoa2313942.

Abstract

BACKGROUND

Most moderate-to-late-preterm infants need nutritional support until they are feeding exclusively on their mother's breast milk. Evidence to guide nutrition strategies for these infants is lacking.

METHODS

We conducted a multicenter, factorial, randomized trial involving infants born at 32 weeks 0 days' to 35 weeks 6 days' gestation who had intravenous access and whose mothers intended to breast-feed. Each infant was assigned to three interventions or their comparators: intravenous amino acid solution (parenteral nutrition) or dextrose solution until full feeding with milk was established; milk supplement given when maternal milk was insufficient or mother's breast milk exclusively with no supplementation; and taste and smell exposure before gastric-tube feeding or no taste and smell exposure. The primary outcome for the parenteral nutrition and the milk supplement interventions was the body-fat percentage at 4 months of corrected gestational age, and the primary outcome for the taste and smell intervention was the time to full enteral feeding (150 ml per kilogram of body weight per day or exclusive breast-feeding).

RESULTS

A total of 532 infants (291 boys [55%]) were included in the trial. The mean (±SD) body-fat percentage at 4 months was similar among the infants who received parenteral nutrition and those who received dextrose solution (26.0±5.4% vs. 26.2±5.2%; adjusted mean difference, -0.20; 95% confidence interval [CI], -1.32 to 0.92; P = 0.72) and among the infants who received milk supplement and those who received mother's breast milk exclusively (26.3±5.3% vs. 25.8±5.4%; adjusted mean difference, 0.65; 95% CI, -0.45 to 1.74; P = 0.25). The time to full enteral feeding was similar among the infants who were exposed to taste and smell and those who were not (5.8±1.5 vs. 5.7±1.9 days; P = 0.59). Secondary outcomes were similar across interventions. Serious adverse events occurred in one infant.

CONCLUSIONS

This trial of routine nutrition interventions to support moderate-to-late-preterm infants until full nutrition with mother's breast milk was possible did not show any effects on the time to full enteral feeding or on body composition at 4 months of corrected gestational age. (Funded by the Health Research Council of New Zealand and others; DIAMOND Australian New Zealand Clinical Trials Registry number, ACTRN12616001199404.).

摘要

背景

大多数中晚期早产儿需要营养支持,直到他们完全以母亲的母乳为食。缺乏指导这些婴儿营养策略的证据。

方法

我们进行了一项多中心、双因素、随机试验,涉及出生于 32 周零 0 天至 35 周零 6 天、有静脉通路且母亲打算母乳喂养的婴儿。每个婴儿被分配到三个干预措施或其对照措施:静脉内氨基酸溶液(肠外营养)或葡萄糖溶液,直到完全用牛奶喂养;当母乳不足或仅用母乳且不补充时给予牛奶补充;以及在胃管喂养前进行味觉和嗅觉暴露或不进行味觉和嗅觉暴露。肠外营养和牛奶补充干预的主要结局是校正胎龄 4 个月时的体脂肪百分比,味觉和嗅觉干预的主要结局是完全肠内喂养的时间(每天每公斤体重 150 毫升或纯母乳喂养)。

结果

共有 532 名婴儿(男婴 291 名[55%])参加了试验。接受肠外营养和接受葡萄糖溶液的婴儿 4 个月时的体脂肪百分比相似(26.0±5.4% vs. 26.2±5.2%;调整后的平均差异,-0.20;95%置信区间[CI],-1.32 至 0.92;P=0.72),接受牛奶补充和仅接受母亲母乳的婴儿相似(26.3±5.3% vs. 25.8±5.4%;调整后的平均差异,0.65;95%CI,-0.45 至 1.74;P=0.25)。接受味觉和嗅觉暴露的婴儿和未接受味觉和嗅觉暴露的婴儿完全肠内喂养的时间相似(5.8±1.5 天 vs. 5.7±1.9 天;P=0.59)。次要结局在各干预组中相似。一名婴儿发生严重不良事件。

结论

这项针对中晚期早产儿的常规营养干预试验,旨在支持他们完全以母亲的母乳为食,直到完全营养,结果显示,该试验在完全肠内喂养的时间或校正胎龄 4 个月时的身体成分方面均无任何效果。(由新西兰健康研究委员会和其他机构资助;DIAMOND 澳大利亚新西兰临床试验注册编号,ACTRN12616001199404。)

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