Effect of Erythropoietin on Neurodevelopmental Outcomes in Very Preterm Infants With Intraventricular Hemorrhage
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Erythropoietin (EPO) has been shown to be neurotrophic and neuroprotective in several animal models and some clinical studies. Our hypothesis is that EPO could improve long-term neurological outcomes in very preterm infants with intraventricular hemorrhage (IVH). The aim of this study is to evaluate the long-term neuroprotective effect of repeated low-dose EPO (500 U/kg) in very preterm infants with IVH.
详细描述
IVH is one of the most common complications in preterm infants. Nearly 60% of preterm infants with grade III-IV IVH develop severe neurodevelopmental outcomes. There are currently no effective treatments to prevent preterm infants with IVH from developing ventricular dilation or serious neurological disabilities. Recent studies have shown that EPO could improve neurodevelopmental outcomes in preterm infants with grade III-IV IVH. However, the dose and course of EPO in preterm infants is still uncertain. The purpose of the study was whether repeated low-dose EPO (500 U/kg, every other day, for 2 weeks) given to very preterm right after the diagnosis of IVH could improve long-term neurological outcomes. Very preterm infants with gestational age of ≤ 32 weeks who are diagnosed with IVH within 72 hours after birth in NICU are eligible for enrolment. After informed consent is obtained, infants will be randomly assigned to EPO group or vehicle group. The primary outcome is whether EPO improves mortality and neurological disabilities in very preterm infants with IVH at 18 months of corrected age, and the secondary outcome was whether EPO decrease the incidence of cerebral palsy, MDI<70, blindness, and deafness.
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 admitted to NICU ≤ 32 weeks gestation at birth
- •Birth weight less than 1500 g
- •Less than 72 hours of life at time of enrolment
- •Diagnosed as IVH by head ultrasound
- •Written informed consent of parent or guardian
排除标准
- •Genetic metabolic diseases
- •Congenital abnormalities
- •Polycythaemia (Hct > 65%) within first 24 hours of life
- •Thrombocytopenia (platelets < 50K cells/microL) within first 24 hours of life
- •Unstable vital signs (such as respiration and circulation failure)
研究组 & 干预措施
Erythropoietin
EPO is administered 500IU/kg, intravenously after diagnosis of IVH within 72h after birth, and every other day for 2 weeks. Recombinant human erythropoietin was configured by the hospital pharmacy intravenous Centre Configuration, melted configured with saline to 1ml/kg solution.
干预措施: Erythropoietin (Drug)
Normal saline
Normal saline is administered the same volume with EPO, intravenously after diagnosis of IVH within 72h after birth, and every other day for 2 weeks.
干预措施: Normal saline (Drug)
结局指标
主要结局
Mortality
时间窗: At corrected age of 18 months
To compare the death rate in EPO treatment and control groups at 18 months of corrected age.
Incidence of neurological disability
时间窗: At corrected age of 18 months
To evaluate neurodevelopmental function via Bayley Infant Development scale (2nd Edition), visual acuity and auditory brainstem response measurements at 18 months of corrected age.
次要结局
- Incidence of MDI<70(At corrected age of 18 months)
- Incidence of cerebral palsy(At corrected age of 18 months)
- Incidence of blindness(At corrected age of 18 months)
- Incidence of deafness(At corrected age of 18 months)
- The effect of EPO treatment on blood mRNA expression(At 3 weeks after birth)
研究者
Changlian Zhu
Director, Clinical research center
Third Affiliated Hospital of Zhengzhou University