Simulated Amniotic Fluid Like Solution Enterally Administrated in Neonates Recovering From GIT Surgeries
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
- Signs of feeding intolerance
研究概览
简要总结
Amniotic fluid plays a significant role in fetal gut maturation and development. 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 neonates recovering from surgery for congenital bowel abnormalities, the investigators will study the role of enteral administration of simulated amniotic fluid solution in prevention of feeding intolerance and NEC in neonates recovering from GIT surgeries.
详细描述
Neonates with congenital GIT anomalies will participate after being operated.
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
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates with operable congenital bowel abnormalities
排除标准
- •Critically ill babies.
- •Presence of any contraindications to enteral feeding
研究组 & 干预措施
SAFE group
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: SAFE group (Drug)
Placebo
Placebo group: distilled water 2.5 ml/kg every 3 hours enterally given.
干预措施: placebo group (Drug)
结局指标
主要结局
Signs of feeding intolerance
时间窗: through study completion, an average of 1 year
Feeding intolerance defined as distended loops of bowel, bilious vomiting, large pre-feeding gastric residuals more than 20% of each feed, diarrhea, occult or gross blood in stools, abdominal wall erythema or ecchymosis
次要结局
- mortality(he outcome measure will be assessed within 2 months)
- hospital stay(through study completion, an average of 1 year)
- Necrotizing enterocolitis(The outcome measure will be assessed within 2 months)
研究者
Rania Ali El-Farrash
Clinical Professor
Ain Shams University