The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Necrotizing enterocolitis
研究概览
简要总结
Study, the inclusion of very low birth weight premature infants followed in Dr.Sami Ulus Maternity and Children Training and Research Hospital, Department of Neonatology; be randomized to very low birth weight premature infants began eating until you are discharged from the hospital once a day to feed a group+ 900 mg of 5 billion active Bifidobacterium lactis, the addition of chicory inulin, in the other group given placebo; Patients taking weekly blood cultures, the presence of residues in both groups during feeding, to evaluate the incidence of NEC and sepsis are planned. Randomization and the number of patients planned to separate into groups.
详细描述
Patients separated into four groups using the sealed envelope method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •VLBW infants admitted to NICU at the first 7 days of life
排除标准
- •expected life lower than 7 days,
- •babies who could not be fed (any metabolic disorders, gastrointestinal system surgical disorders etc.),
- •severe asphyxia,
- •severe congenital anomaly
结局指标
主要结局
Necrotizing enterocolitis
时间窗: 8 weeks
Developing of \>= grade 2 necrotizing enterocolitis suggested by radiological investigation
次要结局
- length of hospital stay(16 weeks)
研究者
Dilek Dilli
Assoc Prof
Dr. Sami Ulus Children's Hospital