The Efficacy of Symbiotic Preparation on Cytokines Which Act on Necrotising Enterocolitis Pathogenesis in Very Low Birth Weight Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Interleukin 5 Serum Cytokine Level on 0+2 Day
研究概览
简要总结
The aim of this prospective double blinded randomised study is to investigate the efficacy of symbiotic preparation which contains lactobacillus casei, L. rhamnosus, L. plantarum, Bifidobacterium lactis, fructo and galactooligosaccharide on cytokines as interferon-gama acting on Th1 pathway, interleukin -5 acting on Th2, interleukin -10 acting on T regulatory pathway, and interleukin -17 acting on Th-17 pathway that were related with necrotizing enterocolitis pathogenesis in very low birth weight neonates.
详细描述
Inclusion criteria:
- Neonates who born 26- 32 gestational week and 750-1500 gram birth weights
- Neonates who tolerated minimal enteral feeding within postnatal first week
Exclusion criteria:
- PROM> 24 hours and/or chorioamnionitis
- Mechanic ventilation supply more than 7 days
- Culture proven sepsis
- Major congenital anomaly
- Patients undergoing surgery
Intervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Hour 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Neonates born 26- 32 gestational weeks and 750-1500 gram birth weights
- •Neonates who tolerated minimal enteral feeding during first week of life
排除标准
- •PROM> 24 hour and/or chorioamnionitis
- •Mechanical ventilation supply more than 7 days
- •Culture proven sepsis
- •Major congenital anomaly
- •Neonates undergoing surgery
研究组 & 干预措施
symbiotic
symbiotic preparation 1/2 sachet twice daily during 30 days
干预措施: symbiotic (Drug)
distilled water
2 x 0.5 cc distilled water will be given during 30 days
干预措施: distilled water (Other)
结局指标
主要结局
Interleukin 5 Serum Cytokine Level on 0+2 Day
时间窗: 0+2 day
Interleukin 5 Levels on 14+/-2 Day
时间窗: 14+/-2 day
Interleukin 5 Levels at 28+/-2 Day
时间窗: 28+/-2 day
Interleukin 10 Levels at 14+/- 2 Days
时间窗: 14+/- 2 days
Interleukin 10 Levels at 28+/-2 Days
时间窗: 28+/-2 days
Interleukin 17A Levels at 0+2 Days
时间窗: 0+2 days
Interleukin 17A Levels at 14+/- 2 Days
时间窗: 14+/- 2 days
Interleukin 17A Levels at 28+/-2 Days
时间窗: 28+/-2 days
Interferon Levels at 0+2 Days
时间窗: 0+2 days
Interleukin 10 Levels at 0+2 Days
时间窗: 0+2 days
Interferon Levels at 14+/-2 Days
时间窗: 14+/-2 days
Interferon Levels at 28+/-2 Days
时间窗: 28+/-2 days
次要结局
未报告次要终点
研究者
Ozge Serce
specialist in neonatology
Zeynep Kamil Maternity and Pediatric Research and Training Hospital