Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,285
- 试验地点
- 1
- 主要终点
- Incidence of NEC
研究概览
简要总结
This study evaluates the effect of repeated low-dose erythropoietin (EPO) treatment on necrotizing enterocolitis (NEC) in very preterm infants. Half of participants will receive EPO, while the other half will receive a placebo.
详细描述
NEC is one of the most severe complications in preterm neonates and is associated with high morbility and mortality. Studies have reported that EPO treatment decreases the incidence and severity of experimental NEC in animal models. Evidence from previous clinical studies about the effect of EPO treatment against NEC have all been hampered by small numbers of patients. The study is to investigate whether repeated low-dose EPO protects against NEC. Preterm infants with gestational age ≤32 weeks who are admitted to neonatal intensive care units within 72 hours after birth are randomized to EPO (500IU/kg, intravenously every other day for 2 weeks) or control group (the same volume of saline). Primary outcome is the incidence of NEC at 36 weeks of corrected age. Secondary outcome is growth and neurodevelopment at 18 months of corrected age in infants with NEC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with gestation age ≤ 32weeks
- •Within 72 hours after birth
- •Written informed consent obtained from parents
排除标准
- •Genetic or metabolic diseases
- •Congenital abnormalities
- •Polycythemia
- •Intracranial hemorrhage grade III/IV
- •Unstable vital signs (such as respiration and circulation failure)
研究组 & 干预措施
Erythropoietin
Infants in the EPO group are given EPO 500IU/kg dissolved in 2 ml saline intravenously every other day for 2 weeks starting within 72 hours after birth.
干预措施: EPO (Drug)
Normal saline
Infants in the control group are given normal saline intravenously with the same volume as EPO every other day for 2 weeks.
干预措施: Normal saline (Drug)
结局指标
主要结局
Incidence of NEC
时间窗: At 36 weeks of corrected age
To compare the incidence of NEC between EPO group and control group at 36 weeks of corrected age
次要结局
- Incidence of low height in patients with NEC(At corrected age of 18 months)
- Incidence of low weight in patients with NEC(At corrected age of 18 months)
- Incidence of low head circumference in patients with NEC(At corrected age of 18 months)
- Incidence of MDI<70 in patients with NEC(At corrected age of 18 months)
- Incidence of cerebral palsy in patients with NEC(At corrected age of 18 months)
- Incidence of blindness in patients with NEC(At corrected age of 18 months)
- Incidence of deafness in patients with NEC(At corrected age of 18 months)
- The effect of EPO treatment on blood messenger RNA (mRNA) expression(At 3 weeks after birth)
研究者
Changlian Zhu
Director, Clinical research center of Third Affiliated Hospitial
Zhengzhou University