Oral Probiotics (Infloran®) for Prevention of Necrotizing Enterocolitis in Very Low Birth Weight Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 463
- 试验地点
- 2
- 主要终点
- Incidence of NEC
研究概览
简要总结
Necrotizing enterocolitis (NEC) is one of the most devastating gastrointestinal emergencies in preterm neonates and a leading cause of death and morbidity.
The pathogenesis of NEC remains largely unclear, but it is widely considered as a multifactorial disease. Prematurity, enteral feeding, bacterial colonisation of the gut and intestinal ischemia have been proposed as major risk factors.
Probiotics may prevent NEC by improving the maturity and function of the gut mucosal barrier, modulating the immune system, promoting colonization of the gut with beneficial organisms and preventing colonization by pathogens.
A variety of clinical trials have evaluated the effect of different probiotic preparations on the occurrence of NEC in preterm infants. The results of recent metaanalyses suggest a benefit of probiotic bacteria in reducing the incidence of NEC and propose a change of practice.
The aim of the study is to evaluate the efficacy of the probiotic preparation Infloran® in reducing the incidence of NEC after implementation in clinical routine in preterm (< 34 weeks gestational age) very low birth weight infants compared to a historical cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates admitted to the neonatal intensive care unit on day 1 of life
- •Very low birth weight (<1500 gram)
- •Prematurity < 34/0 weeks gestational age
- •For group receiving probiotics: 230 infants born after the 20/Sep/2010 (i.e. date of introduction of Infloran in clinical routine)
- •For control group (historical): 230 infants born before 2010
排除标准
- •Malformation of the gut (omphalocele, gastroschisis, intestinal atresia)
- •Death before seven days of life, except due to NEC
- •Transfer to another hospital before 37 weeks of corrected gestational age, except those who were transferred to a partner clinic using the same protocol for probiotic supplementation
- •For group receiving probiotics: Infants who did not receive Infloran® starting in the first week of life or stopped before 34 weeks gestational age, except infants who developed NEC (reason for discontinuation of Infloran)
结局指标
主要结局
Incidence of NEC
时间窗: From birth to 37 weeks of gestational age (usually around 12 weeks)
NEC stages 2 or 3 according to Bell´s modified staging of NEC
次要结局
- Severity of NEC(From birth to 37 weeks of gestational age (usually around 12 weeks))
- Influence of enteral feeding with human milk or formula on the incidence of NEC after the implementation of Infloran®(From birth to 37 weeks of gestational age (usually around 12 weeks))
研究者
Andreas Repa
MD
Medical University of Vienna