Department of Pediatrics, Saint Louis University School of Medicine, St Louis, MO, USA.
J Perinatol. 2012 Apr;32(4):253-9. doi: 10.1038/jp.2011.51. Epub 2011 May 5.
The objective of this trial was to test whether probiotic-supplemented feeding to extremely low-birth-weight (ELBW) infants will improve growth as determined by decreasing the percentage of infants with weight below the 10th percentile at 34 weeks postmenstrual age (PMA). Other important outcome measures, such as improving feeding tolerance determined by tolerating larger volume of feeding per day and reducing antimicrobial treatment days during the first 28 days from the initiation of feeding supplementation were also evaluated.
We conducted a multicenter randomized controlled double-blinded clinical study. The probiotics-supplementation (PS) group received Lactobacillus rhamnosus GG and Bifidobacterium infantis added to the first enteral feeding and continued once daily with feedings thereafter until discharge or until 34 weeks (PMA). The control (C) group received unsupplemented feedings. Infant weight and feeding volumes were recorded daily during the first 28 days of study period. Weights were also recorded at 34 weeks PMA.
A total of 101 infants were enrolled (PS 50 versus C 51). There was no difference between the two groups in the percentage of infants with weight below the 10th percentile at 34 weeks PMA (PS group 58% versus C group 60%, (P value 0.83)) or in the average volume of feeding during 28 days after study entry (PS group 59 ml kg(-1) versus C group 71 ml kg(-1), (P value 0.11)). Calculated growth velocity was higher in the PS group compared with the C group (14.9 versus 12.6 g per day, (P value 0.05)). Incidences of necrotizing enterocolitis (NEC), as well as mortality were similar between the two groups.
Although probiotic-supplemented feedings improve growth velocity in ELBW infants, there was no improvement in the percentage of infants with growth delay at 34 weeks PMA. There were no probiotic-related adverse events reported.
本试验旨在测试在极低出生体重儿(ELBW)中添加益生菌喂养是否能通过降低出生后 34 周(PMA)时体重低于第 10 百分位数的婴儿比例来改善生长。其他重要的结局指标,如通过耐受更大的每日喂养量来改善喂养耐受性,并减少从开始喂养补充后的前 28 天内的抗生素治疗天数也进行了评估。
我们进行了一项多中心、随机、对照、双盲临床研究。益生菌补充(PS)组在开始肠内喂养时添加鼠李糖乳杆菌 GG 和婴儿双歧杆菌,此后每天喂食一次,直至出院或直至 34 周(PMA)。对照组(C)组接受未补充喂养。在研究期间的前 28 天,每天记录婴儿的体重和喂养量。在 34 周 PMA 时也记录体重。
共有 101 名婴儿入组(PS 组 50 例,C 组 51 例)。两组在 34 周 PMA 时体重低于第 10 百分位数的婴儿比例(PS 组 58%,C 组 60%,(P 值 0.83))或研究入组后 28 天的平均喂养量(PS 组 59 ml·kg-1,C 组 71 ml·kg-1,(P 值 0.11))方面均无差异。与 C 组相比,PS 组的生长速度更高(14.9 比 12.6 g·天-1,(P 值 0.05))。两组坏死性小肠结肠炎(NEC)的发生率以及死亡率相似。
虽然益生菌喂养能改善 ELBW 婴儿的生长速度,但在 34 周 PMA 时,体重增长延迟的婴儿比例没有改善。没有报告与益生菌相关的不良事件。