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临床试验/NCT02036073
NCT02036073已完成4 期

Effect of Erythropoietin on Preterm Brain Injury

Zhengzhou Children's Hospital, China1 个研究点 分布在 1 个国家目标入组 490 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
490
试验地点
1
主要终点
Incidence of MDI<70

研究概览

简要总结

EPO has been safely used for prevent preterm anemia and recent studies have shown the neuroprotective effect. Our hypothesis is that EPO could prevent preterm brain injury. The aims of this study include: to investigate the safety and efficacy of EPO by using 500u/kg higher than the dose of anemia treatment (250u/kg); to evaluate the effect of EPO on neurodevelopment in preterm infants; to detect biological indicators and explore the neuroprotective mechanism of EPO.

详细描述

Periventricular leukomalacia (PVL) is one of the most common brain injuries that occur in preterm infants, which is related with the development of cerebral palsy. The current therapy is only supportive to maintain the live sign stable. There is no effective therapeutic strategy for preterm brain injury. Erythropoietin (EPO) has been shown to be protective against hypoxic-ischemic and inflammatory injuries in animal models of brain injury, and clinical trials of neonatal hypoxic ischemic brain injury. Furthermore, recombinant human Epo (rhEpo) has been widely used in preterm infants to prevent or treat the anemia of prematurity during the past decade. It has been considered to be safe and well tolerated in preterm infants. However, there is no conclusion yet if the EPO has the effect to prevent preterm brain injury. The purpose of the study was whether the rhEpo (500 U/kg) given to very preterm infants (gestation age < 32 weeks) within 24h after birth and subsequently each other day for2 week possesses neuroprotective properties. Very preterm infants with gestational age of < 32 weeks and admit to our NICU are eligible for enrollment. After informed consent is obtained, infants will be randomly assigned to either EPO group or vehicle group. The primary short-term outcome measures are brain injury (intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL)) and ROP. The long term outcomes are whether rhEpo in very preterm infants finally improves neurodevelopmental outcome at 18 months corrected age.

研究设计

研究类型
Interventional
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
1 Day 至 72 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants admitted to the NICU with gestational age <32 weeks
  • birth weight <1500g and less than 72hours of age

排除标准

  • Infants with genetic metabolic diseases
  • Congenital abnormalities
  • Pneumothorax
  • Grade III-IV intracranial hemorrhage

研究组 & 干预措施

EPO

Experimental

In EPO group, the EPO was given by 500IU/kg every other day intravenously for 2 weeks. Recombinant human erythropoietin was configured by the hospital pharmacy intravenous Center Configuration, melted configured with saline to 1ml/kg solution. For severe patients, they were started to treat with EPO when their vital signs, blood pressure were stable.

干预措施: recombinant human erythropoietin (Drug)

结局指标

主要结局

Incidence of MDI<70

时间窗: At corrected age of 18 months

次要结局

  • Incidence of ROP(At the corrected age 42 weeks)

研究者

发起方
Zhengzhou Children's Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Huiqing Sun

Associate Professor

Zhengzhou Children's Hospital, China

研究点 (1)

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