Probiotic Administartion to Mothers of Preterm Infants to Prevent Necrotizing Enterocolitis and Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- all cause mortality at three months of age
研究概览
简要总结
We hypothesize that supplementing maternal diet with probiotics will decrease the incidence of feeding intolerance, necrotizing enterocolitis and sepsis in preterm infants fed breastmilk.
详细描述
Oral probiotics have previously been shown to prevent necrotizing enterocolitis in preterm infants. A few reports of sepsis by a probiotic bacteria have impeded implementation of oral probiotic supplementation in most NICUs. Considering the proven immunomodulatory effect of maternal probiotics on breastfed infants of atopic mothers, we would like to explore the indirect effects of maternal probiotics on preterm infants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mothers of preterm infants
- •Pumping breast milk
排除标准
- •Neonatal congenital anomalies
结局指标
主要结局
all cause mortality at three months of age
时间窗: 3 months
incidence and severity of necrotizing enterocolitis by Bell's staging at Three months
时间窗: 3 months
occurrence of bacterial or fungal infection per blood,csf or urine cultures at three months
时间窗: 3 months
次要结局
- maternal adverse effects during treatment(3 months)
- incidence of BPD, PVL, ROP(36 weeks)