Effect of Oral N-Acetyl Cysteine in Prevention of Necrotizing Enterocolitis in Preterm Neonates With Feeding Intolerance
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- incidence of necrotizing enterocolitis
研究概览
简要总结
necrotizing enterocolitis is a dangerous disease that may be fatal especially in preterm neonates, the early features of the disease are symptoms of feeding intolerance and interruption of the baby's feeding plan , so prophylactic measures at this stage may help to prevent its progression and its complications.
N-acetyl cysteine is an FDA- approved drug and has many uses in different diseases and in different age groups including neonates, it has a mucolytic and anti-inflammatory and anti-oxidant effects that are believed to break the bacterial biofilm which enables it to stick to the intestinal wall and also decrease the intestinal wall inflammation, therefore enhance the intestinal barrier and decrease the chance of bacterial invasion.
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm neonates (less than or = 36 weeks gestational age )
- •feeding intolerance
排除标准
- •active gastro-intestinal tract bleeding
- •Gastro- intestinal tract surgical problem
- •Congenital gastro-intestinal tract anomalies
- •evidence of allergy to NAC
- •use of prebiotics or probiotics
研究组 & 干预措施
intervention group
preterm neonates with feeding intolerance, pre-Nec., receive the drug
干预措施: oral n-acetyl cysteine (Drug)
control group
preterm neonates
干预措施: placebo (Other)
结局指标
主要结局
incidence of necrotizing enterocolitis
时间窗: 10 days
assess the development of necrotizing enterocolitis
次要结局
未报告次要终点