Enteral Administration of a Simulated Amniotic Fluid In Preventing Feeding Intolerance And Necrotizing Enterocolitis In Very Low Birth Weight Neonates
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Necrotizing enterocolitis by modified Bell criteria, mortality in percentage, hospital stay in days. The outcome measure will be assessed within 2 months
研究概览
简要总结
The human fetus swallows over 200 ml of amniotic fluid per kilogram of weight each day and such swallowing is essential for normal small bowel development.Growth factors found in the amniotic fluid have been shown to promote proliferation of fetal intestinal cells. As feeding intolerance is a common problem among premature neonates, the investigators will study the role of enteral administration of simulated amniotic fluid solution in prevention of feeding intolerance and NEC in premature neonates.
详细描述
Very Low Birth Weight (VLBW) neonates.
Participants will be followed for the duration of hospital stay until discharge or death.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 28 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infants with birth weight 1.5 Kg
排除标准
- •Congenital or acquired anomaly of the gastrointestinal tract (i.e., omphalocele, tracheoesophageal fistula, intestinal perforation).
- •Other major congenital anomalies (congenital heart disease, neural tube defect, congenital diaphragmatic hernia, trisomy, etc.).
研究组 & 干预措施
SAFE group
simulated amniotic fluid 20cc/kg/day enterally divided according to number of feds (syringe for every fed). This amount provides enteral 4.5μg rhG-CSF / kg/day and enteral 88IU rhEPO / kg/day.
干预措施: simulated amniotic fluid 20cc/kg/day enterally (Drug)
placebo
distilled water 2.5 ml/kg every 3 hours enterally
干预措施: distilled water (Drug)
结局指标
主要结局
Necrotizing enterocolitis by modified Bell criteria, mortality in percentage, hospital stay in days. The outcome measure will be assessed within 2 months
时间窗: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
次要结局
未报告次要终点
研究者
Rania Ali El-Farrash
Enteral Administration of a Simulated Amniotic Fluid In Preventing Feeding Intolerance And Necrotizing Enterocolitis In Very Low Birth Weight Neonates
Ain Shams University