Safety and Efficacy of Repetitive Erythropoietin Treatment for Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 主要终点
- Adverse events
研究概览
简要总结
This study is a retrospective review on the safety and efficacy of repetitive erythropoietin injection in children with cerebral palsy
详细描述
Cerebral palsy is mostly caused by hypoxic-ischemic encephalopathy from preterm birth, involving inflammatory and apoptotic cellular response. Erythropoietin (EPO) has shown neuroprotective effects via activation of anti-inflammatory, angiogenic, and anti-apoptotic pathways. The safety and feasibility of EPO in children were proven in previous clinical trials. In addition, the efficacy of EPO is actively being investigated and some reports have shown potential benefits in cerebral palsy. To confirm the safety and efficacy of multiple injections with expected effect, retrospective review on medical records was performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 接受健康志愿者
- 否
入选标准
- •confirmed clinical diagnosis of cerebral palsy based on neuromotor findings,
- •less than 18 years of age,
- •received recombinant human erythropoietin (rhEPO) more than once.
排除标准
- •not responding to phone interview or
- •no functional assessments available.
研究组 & 干预措施
recombinant human erythropoietin group
cerebral palsy patients who had received erythropoietin from January 2013 to November 2016
干预措施: recombinant human erythropoietin (Drug)
结局指标
主要结局
Adverse events
时间窗: interview was performed at an average of 1 year after the completion of rhEPO injections
telephone interview was conducted to collect information of adverse events from all patients.
次要结局
- Change of Gross Motor Function Measure(The results between the baseline evaluation before rhEPO injection and the last evaluation at an average of 1 year after rhEPO injections were compared)
研究者
MinYoung Kim, M.D.
Professor
Bundang CHA Hospital