PDF(Pubmed)
Abstract：
BACKGROUND: Extremely preterm infants, defined as those born before 28 weeks\' gestational age, are a very vulnerable patient group at high risk for adverse outcomes, such as necrotizing enterocolitis and death. Necrotizing enterocolitis is an inflammatory gastrointestinal disease with high incidence in this cohort and has severe implications on morbidity and mortality. Previous randomized controlled trials have shown reduced incidence of necrotizing enterocolitis among older preterm infants following probiotic supplementation. However, these trials were underpowered for extremely preterm infants, rendering evidence for probiotic supplementation in this population insufficient to date.
METHODS: The Probiotics in Extreme Prematurity in Scandinavia (PEPS) trial is a multicenter, double-blinded, placebo-controlled and registry-based randomized controlled trial conducted among extremely preterm infants (n = 1620) born at six tertiary neonatal units in Sweden and four units in Denmark. Enrolled infants will be allocated to receive either probiotic supplementation with ProPrems® (Bifidobacterium infantis, Bifidobacterium lactis, and Streptococcus thermophilus) diluted in 3 mL breastmilk or placebo (0.5 g maltodextrin powder) diluted in 3 mL breastmilk per day until gestational week 34. The primary composite outcome is incidence of necrotizing enterocolitis and/or mortality. Secondary outcomes include incidence of late-onset sepsis, length of hospitalization, use of antibiotics, feeding tolerance, growth, and body composition at age of full-term and 3 months corrected age after hospital discharge.
CONCLUSIONS: Current recommendations for probiotic supplementation in Sweden and Denmark do not include extremely preterm infants due to lack of evidence in this population. However, this young subgroup is notably the most at risk for experiencing adverse outcomes. This trial aims to investigate the effects of probiotic supplementation on necrotizing enterocolitis, death, and other relevant outcomes to provide sufficiently powered, high-quality evidence to inform probiotic supplementation guidelines in this population. The results could have implications for clinical practice both in Sweden and Denmark and worldwide.
BACKGROUND: ( Clinicaltrials.gov ): NCT05604846.
METHODS: The Probiotics in Extreme Prematurity in Scandinavia (PEPS) trial is a multicenter, double-blinded, placebo-controlled and registry-based randomized controlled trial conducted among extremely preterm infants (n = 1620) born at six tertiary neonatal units in Sweden and four units in Denmark. Enrolled infants will be allocated to receive either probiotic supplementation with ProPrems® (Bifidobacterium infantis, Bifidobacterium lactis, and Streptococcus thermophilus) diluted in 3 mL breastmilk or placebo (0.5 g maltodextrin powder) diluted in 3 mL breastmilk per day until gestational week 34. The primary composite outcome is incidence of necrotizing enterocolitis and/or mortality. Secondary outcomes include incidence of late-onset sepsis, length of hospitalization, use of antibiotics, feeding tolerance, growth, and body composition at age of full-term and 3 months corrected age after hospital discharge.
CONCLUSIONS: Current recommendations for probiotic supplementation in Sweden and Denmark do not include extremely preterm infants due to lack of evidence in this population. However, this young subgroup is notably the most at risk for experiencing adverse outcomes. This trial aims to investigate the effects of probiotic supplementation on necrotizing enterocolitis, death, and other relevant outcomes to provide sufficiently powered, high-quality evidence to inform probiotic supplementation guidelines in this population. The results could have implications for clinical practice both in Sweden and Denmark and worldwide.
BACKGROUND: ( Clinicaltrials.gov ): NCT05604846.
摘要：
背景：极早产儿，定义为28周胎龄之前出生的人，是一个非常脆弱的患者群体，面临不良后果的高风险，如坏死性小肠结肠炎和死亡。坏死性小肠结肠炎是一种炎症性胃肠道疾病，在该队列中发病率很高，对发病率和死亡率有严重影响。先前的随机对照试验表明，补充益生菌后，年龄较大的早产儿坏死性小肠结肠炎的发生率降低。然而,这些试验对极度早产儿的作用不足，迄今为止，该人群补充益生菌的证据不足。
方法：斯堪的纳维亚极端早产益生菌（PEPS）试验是一个多中心，双盲,在瑞典6个三级新生儿病房和丹麦4个新生儿病房出生的极早产儿(n=1620)中进行了安慰剂对照和基于注册的随机对照试验.登记的婴儿将被分配接受ProPrems®(婴儿双歧杆菌，乳酸双歧杆菌，和嗜热链球菌）在3mL母乳中稀释，或每天在3mL母乳中稀释的安慰剂（0.5g麦芽糊精粉），直至妊娠第34周。主要复合结局是坏死性小肠结肠炎的发生率和/或死亡率。次要结果包括迟发性败血症的发生率，住院时间,使用抗生素，喂养耐受性，增长,足月年龄和出院后3个月校正年龄时的身体成分。
结论：由于缺乏证据，目前瑞典和丹麦对益生菌补充剂的建议并不包括极度早产儿。然而,这一年轻亚组尤其是出现不良结局的风险最大.该试验旨在研究补充益生菌对坏死性小肠结肠炎的影响，死亡,和其他相关结果，以提供足够的动力，高质量的证据为该人群的益生菌补充指南提供信息。结果可能对瑞典和丹麦以及全世界的临床实践产生影响。
背景：（Clinicaltrials.gov）：NCT05604846。
方法：斯堪的纳维亚极端早产益生菌（PEPS）试验是一个多中心，双盲,在瑞典6个三级新生儿病房和丹麦4个新生儿病房出生的极早产儿(n=1620)中进行了安慰剂对照和基于注册的随机对照试验.登记的婴儿将被分配接受ProPrems®(婴儿双歧杆菌，乳酸双歧杆菌，和嗜热链球菌）在3mL母乳中稀释，或每天在3mL母乳中稀释的安慰剂（0.5g麦芽糊精粉），直至妊娠第34周。主要复合结局是坏死性小肠结肠炎的发生率和/或死亡率。次要结果包括迟发性败血症的发生率，住院时间,使用抗生素，喂养耐受性，增长,足月年龄和出院后3个月校正年龄时的身体成分。
结论：由于缺乏证据，目前瑞典和丹麦对益生菌补充剂的建议并不包括极度早产儿。然而,这一年轻亚组尤其是出现不良结局的风险最大.该试验旨在研究补充益生菌对坏死性小肠结肠炎的影响，死亡,和其他相关结果，以提供足够的动力，高质量的证据为该人群的益生菌补充指南提供信息。结果可能对瑞典和丹麦以及全世界的临床实践产生影响。
背景：（Clinicaltrials.gov）：NCT05604846。
