Effect of Bifidobacterium Bifidum Supplementation on Morbidity of Very Low Birth Weight Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 2
- 主要终点
- Postnatal day when enteral feeding exceeded at 100ml/kg/day
研究概览
简要总结
Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum early after birth. In order to evaluate these beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to preterm infants improve enteral feeding and growth in very low birth weight infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with birth weight less than 1500g
排除标准
- •Sever bacteremia
- •Congenital anomaly
- •Not suitable for the trial defined by an attending neonatologist
结局指标
主要结局
Postnatal day when enteral feeding exceeded at 100ml/kg/day
时间窗: From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth
Death or unsuccessful of establishing enteral feeding exceeded at 100ml/kg/day before day 28 of age is considered failure to reach primary endpoint.
次要结局
- standard deviation(SD) scores of bodyweight(BW) and head circumference(HC)(For the duration of NICU stay, an expected average of 3 months)
- Necrotizing enterocolitis or sepsis(For the duration of NICU stay, an expected average of 3 months)
- Intestinal flora(For the duration of NICU stay, an expected average of 3 months)
研究者
Satoshi Kusuda
Professor of Neonatology
Tokyo Women's Medical University