Prebiotics vs. Placebo in the Prevention of Necrotizing Enterocolitis in Premature Neonates
试验速览
- 阶段
- 2 期
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Incidence of Necrotizing Enterocolitis
研究概览
简要总结
Necrotizing enterocolitis (NEC) is the most common gastrointestinal catastrophe affecting 10-15% of premature neonates of <1500 gm. NEC is a disease of the immature intestine, characterized by impaired mucosal barrier function leading to increased gut permeability. We have previously demonstrated a protective effect of probiotic administration against the development of NEC. Others have shown that prebiotics can stimulate natural production of bifidobacteria and lactobacillus in the preterm gut. We have therefore hypothesized that prophylactic administration of prebiotics would also provide protection against necrotizing enterocolitis in the premature neonate, without the potential for sepsis which has been reported on rare occasions with probiotics administration.
详细描述
Specifically, we hope to demonstrate that fewer of the babies who are treated with galacto-oligosaccharides (GOS) will develop NEC as compared with controls.
Preterm neonates, <1750 gm birth weight will potentially be candidates for study. They will be randomly assigned to receive one of two milk additives from the time enteral feeds are begun until 35 weeks post-conceptual age: prebiotics (GOS) or placebo (water). All infants will be followed prospectively for signs of feeding intolerance and/or development of NEC. These will be compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates
- •< 1750 gm birth weight
排除标准
- •Infants who are deemed unlikely to survive
- •Infants with significant congenital malformations
- •Infants with other gastrointestinal problems
结局指标
主要结局
Incidence of Necrotizing Enterocolitis
时间窗: yearly
次要结局
- fecal calprotectin, urine IFABP(end of study)
- NEC related morbidity, ie. perforation, surgery [including peritoneal drain placement](yearly)
- Stool bifidobacteria(End of study)
研究者
Cathy Hammerman
Professor of Pediatrics
Shaare Zedek Medical Center