A Clinical Study on the Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Efficacy of Docosahexaenoic Acid in reducing the incidence of Necrotizing Enterocolitis in premature infants.
研究概览
简要总结
The study will assess the efficacy of Docosahexaenoic Acid in reducing the incidence of necrotizing enterocolitis in premature infants.
详细描述
The efficacy of Docosahexaenoic Acid in reducing the incidence of necrotizing enterocolitis in preterm neonates will be evalutaed through measuring its immune-modulatory effect on proinflammatory cytokines.
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
- None
入排标准
- 年龄范围
- 1 Day 至 3 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates having a gestational age equal or less than 34 weeks at birth.
- •Weight (less than or equal 1.500 KG)
- •Clinically stable to begin enteral feeding
排除标准
- •Persistent bleeding at any level.
- •Receiving medication to avoid coagulation.
- •Persistent vomiting.
- •Gastrointestinal malformations.
- •Mother taking Omega-3 supplements and planning to breastfeed.
研究组 & 干预措施
Control Group
participants will recieve placebo
干预措施: placebo (Other)
Docosahexaenoic Acid Group
participants will recieve 100 milligrams of Docosahexaenoic Acid per day for 14 days
干预措施: Docosahexaenoic Acid (Dietary Supplement)
结局指标
主要结局
Efficacy of Docosahexaenoic Acid in reducing the incidence of Necrotizing Enterocolitis in premature infants.
时间窗: 10 days
Monitoring the change in the serum levels of Interleukin-1 beta
次要结局
未报告次要终点
研究者
Dina Khaled Mohamed Abou El Fadl
Assistant Lecturer
Future University in Egypt