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一项关于益生元低聚糖对早产儿肠内耐受性影响的随机、双盲、对照试验(ISRCTN77444690)。

A randomized, double-blind, controlled trial of the effect of prebiotic oligosaccharides on enteral tolerance in preterm infants (ISRCTN77444690).

机构信息

Division of Medicine, Section of Neonatal Medicine, Chelsea and Westminster Hospital Campus, Imperial College London, London SW10 9NH, United Kingdom.

出版信息

Pediatr Res. 2010 Nov;68(5):440-5. doi: 10.1203/PDR.0b013e3181f1cd59.

DOI:10.1203/PDR.0b013e3181f1cd59
PMID:20639792
Abstract

Breast milk prebiotic oligosaccharides are believed to promote enteral tolerance. Many mothers delivering preterm are unable to provide sufficient milk. We conducted a multicenter, randomized, controlled trial comparing preterm formula containing 0.8 g/100 mL short-chain galacto-oligosaccharides/long-chain fructo-oligosaccharides in a 9:1 ratio and an otherwise identical formula, using formula only to augment insufficient maternal milk volume. Infants were randomized within 24 h of birth. The primary outcome (PO) was time to establish a total milk intake of 150 mL/kg/d PO and the principal secondary outcome (PSO) was proportion of time between birth and 28 d/discharge that a total milk intake of ≥ 150 mL/kg/d was tolerated. Other secondary outcomes included growth, fecal characteristics, gastrointestinal signs, necrotizing enterocolitis, and bloodstream infection. Outcomes were compared adjusted for prespecified covariates. We recruited 160 infants appropriately grown for GA <33 wk. There were no significant differences in PO or PSOs. After covariate adjustment, we showed significant benefit from trial formula in PSO with increasing infant immaturity (2.9% improved tolerance for a baby born at 28-wk gestation and 9.9% at 26-wk gestation; p < 0.001) but decreased or no benefit in babies >31-wk gestation. Prebiotic supplementation appears safe and may benefit enteral tolerance in the most immature infants.

摘要

母乳低聚糖被认为可促进肠道耐受。许多早产儿母亲无法提供足够的母乳。我们开展了一项多中心、随机、对照试验,比较了含有 0.8 g/100 mL 短链半乳糖-低聚糖/长链果糖-低聚糖(9:1 比例)的早产儿配方奶和其他相同配方的配方奶,仅用配方奶来补充不足的母乳量。婴儿在出生后 24 小时内随机分组。主要结局(PO)为达到 150 mL/kg/d 的总奶量的时间,主要次要结局(PSO)为出生至 28 天/出院期间达到 150 mL/kg/d 总奶量的时间比例。其他次要结局包括生长、粪便特征、胃肠道症状、坏死性小肠结肠炎和血流感染。结果根据预设协变量进行调整。我们招募了 160 名适合胎龄 <33 周的适当生长的婴儿。PO 或 PSO 无显著差异。在协变量调整后,我们发现试验配方在婴儿不成熟度增加时(胎龄 28 周时耐受性提高 2.9%,胎龄 26 周时提高 9.9%;p<0.001),PSO 中具有显著获益,但在胎龄>31 周的婴儿中获益减少或无获益。益生元补充似乎是安全的,可能有益于最不成熟婴儿的肠道耐受。

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