NCT00977912终止不适用
Prevention of NEC in Preterm Infants With B. Lactis
Société des Produits Nestlé (SPN)6 个研究点 分布在 1 个国家目标入组 318 人开始时间: 2009年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 318
- 试验地点
- 6
- 主要终点
- NEC onset
研究概览
简要总结
The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in 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
- 年龄范围
- 12 Hours 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Weight between 800 - 1500g
- •Tolerating enteral feeding within 48 hours
- •Having obtained his/her parents or legal representative informed consent
排除标准
- •Chromosomal abnormality
- •Hydrops featalis
- •Congenital malformation of the gastrointestinal tract
- •Congenital heart defects or other major congenital abnormalities likely to affect feeding and/or feeding tolerance
- •Currently participating in another clinical trial
结局指标
主要结局
NEC onset
时间窗: 6 weeks
次要结局
- Antibiotic administration and stool microbiology(6 weeks)
研究者
研究点 (6)
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