Enteral Granulocyte Colony Stimulating Factor and Erythropoietin Early in Life Increases Feeding Tolerance in Preterm Infants: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 93
- 主要终点
- Duration of hospitalization
研究概览
简要总结
With preterm birth, the ingestion of amniotic fluid containing enterocyte trophic factors ceases abruptly. This likely predisposes them to villous atrophy feeding intolerance and necrotizing enterocolitis(NEC) once feedings are instituted.Granulocyte Colony-Stimulating Factor (G-CSF) and Erythropoietin (EPO) have important non-hematopoietic roles in human developmental biology. Among these roles, they have trophic actions on villous height and bowel length of the developing intestine.The aim of this study is to evaluate the efficacy of enteral recombinant human G-CSF and recombinant human EPO in prevention of feeding intolerance and /or NEC in preterm infants.
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 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •premature neonates < 33 weeks gestational age
排除标准
- •major congenital anomalies
- •prior use of cytokines
研究组 & 干预措施
EPO
干预措施: rh EPO (Drug)
G-CSF and EPO
干预措施: recombinant human G-CSF, and rhEPO (Drug)
G-CSF
干预措施: rh G-CSF (Drug)
G-CSF and EPO
干预措施: rh G-GSF and rh EPO together (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Duration of hospitalization
时间窗: 2 months
Time to stop parentral nutrition
时间窗: one month
Day of onset of weight gain
时间窗: one month
The times taken to establish quarter, half, three quarters, and full enteral feeding after the drug treatment (at least 150ml/kg/day).
时间窗: one month
次要结局
- Necrotizing enterocolitis (NEC)stage (if any)(2 months)
研究者
Rania Ali El-Farrash
Principal investigator
Ain Shams University