ISRCTN05511098已完成不适用
The probiotic Bifidobacterium breve strain BBG-001 administered early to preterm infants to prevent infection, necrotising enterocolitis and death: a double-blind randomised placebo-controlled trial
Queen Mary, University of London (UK)0 个研究点目标入组 1,300 人开始时间: 2009年9月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Both males and females, born before 31 completed weeks of gestation, i.e. up to and including 30 weeks + 6 days by the best estimate of Expected Date of Delivery (usually by first trimester antenatal ultrasound, alternatively calculated from the first day of the last menstrual period [LMP])
- •2. Less than 48 hours old
- •3. With written informed parental consent
- •4. Babies already on antibiotics for suspected or proven infection are eligible for recruitment to the study
排除标准
- •1. A lethal congenital abnormality known at trial entry
- •2. Any known gastrointestinal malformation
- •3. No realistic prospect of survival
研究者
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