Kaban Risma K, Hegar Badriul, Rohsiswatmo Rinawati, Handryastuti Setyo, Amelia Novie, Muktiarti Dina, Indrio Flavia, Vandenplas Yvan
Department of Pediatric Health, Faculty of Medicine, Universitas Indonesia-Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.
Department of Paediatrics, University of Bari, Bari, Italy.
Pediatr Gastroenterol Hepatol Nutr. 2019 Nov;22(6):545-553. doi: 10.5223/pghn.2019.22.6.545. Epub 2019 Nov 7.
Feeding tolerance is extremely important in preterm infants. This study aimed to evaluate whether preterm infants receiving DSM 17938 would develop fewer symptoms of feeding intolerance. Secondary outcomes were duration of parenteral nutrition, time to reach full feeding, length of hospital stay, sepsis, necrotizing enterocolitis (NEC), diarrhea, and mortality.
This double-blind randomized controlled trial of DSM 17938 versus placebo included 94 neonates with a gestational age of 28-34 weeks and birth weight of 1,000-1,800 g.
Feeding intolerance (vomiting and/or distension) was less common in the probiotic group than in the placebo group (8.5% vs. 25.5%; relative risk, 0.33; 95% confidence interval, 0.12-0.96; =0.03). No significant intergroup differences were found in proven sepsis, time to reach full feeding, length of hospital stay, or diarrhea. The prevalence of NEC (stages 2 and 3) was 6.4% in the placebo group vs. 0% in the probiotic group (relative risk, 1.07; 95% confidence interval, 0.99-1.15; =0.24). Mortality rates were 2.1% in the probiotic group and 8.5% in the placebo group, =0.36).
The administration of DSM 17938 to preterm infants was safe and significantly reduced feeding intolerance. No significant differences were found in any other secondary outcomes.
喂养耐受性对早产儿极为重要。本研究旨在评估接受DSM 17938的早产儿是否会出现较少的喂养不耐受症状。次要结局包括肠外营养持续时间、达到完全喂养的时间、住院时间、败血症、坏死性小肠结肠炎（NEC）、腹泻和死亡率。
这项将DSM 17938与安慰剂进行对比的双盲随机对照试验纳入了94例胎龄为28 - 34周、出生体重为1000 - 1800克的新生儿。
益生菌组的喂养不耐受（呕吐和/或腹胀）情况比安慰剂组少见（8.5%对25.5%；相对风险，0.33；95%置信区间，0.12 - 0.96；P = 0.03）。在确诊的败血症、达到完全喂养的时间、住院时间或腹泻方面，未发现显著的组间差异。安慰剂组NEC（2期和3期）的患病率为6.4%，益生菌组为0%（相对风险，1.07；95%置信区间，0.99 - 1.15；P = 0.24）。益生菌组的死亡率为2.1%，安慰剂组为8.5%，（P = 0.36）。
给早产儿施用DSM 17938是安全的，且能显著降低喂养不耐受。在任何其他次要结局方面均未发现显著差异。
