Probiotics to Prevent NEC Stage II+ in Very Preterm Infants - a Historical Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 714
- 试验地点
- 1
- 主要终点
- NEC
研究概览
简要总结
Probiotics is given routinely to infants admitted to the department of neonatology during the first 3 days of life with gestational age less than 30 weeks since March 2010. The incidence of necrotizing enterocolitis Bell stage II and III will be assessed blindly from clinical records. It is hypothesised that the incidence of NEC will decrease. Infants admitted from 1 March 2010 to 28 February 2013 will be compared to infants admitted 1 Dec 2007 to 30 Nov 2009 will be compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
入排标准
- 年龄范围
- — 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age less than 30 weeks
- •Admission during the first 3 days of life
排除标准
- 未提供
结局指标
主要结局
NEC
时间窗: From birth until discharge home
The clinical records of infants who had a discharge diagnosis of necrotizing enterocolitis are selected. Records of infants who had a prescription of metronidazole for a non-preventive purpose is added. The clinical records are abstracted. The abstracts and X-rays are presented to a review board that are blinded to the period of birth. The board classifies the cases as NEC-I, NEC-II, NEC-III, focal intestinal perforation, and OTHER. NEC-II/III is the primary outcome.
次要结局
- Death with NEC(Birth to discharge home)
- Death(Birth to discharge home)
研究者
Gorm Greisen
professor, consultant neonatologist
Rigshospitalet, Denmark