Neonatal Erythropoietin in Asphyxiated Term Newborns: a Phase I Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Serious adverse event
研究概览
简要总结
The purpose of this study is to determine the safety and pharmacokinetics of moderate to high doses of erythropoietin in newborn infants with birth asphyxia.
详细描述
Newborn infants with birth asphyxia are at high risk of death or long-term neurologic disability; yet therapies for birth asphyxia are currently limited. Erythropoietin (Epo) is a FDA-approved drug that is an effective neuroprotective agent in animal models of birth asphyxia. This is a phase I dose finding multi-center trial that will test the safety and pharmacokinetics of Epo in human infants with birth asphyxia. The long-term objectives of the proposed research are to reduce mortality and to decrease the risk of long-term disabilities in infants who survive beyond the newborn period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 36 weeks gestational age
- •Perinatal depression (low Apgar score, need for resuscitation)
- •Moderate to severe encephalopathy
排除标准
- •Specific aEEG findings
- •Intrauterine growth restriction
- •Severe congenital anomaly, genetic syndrome, metabolic disorder, arthrogryposis, TORCH infection
- •Microcephaly
- •Infant older than 23.5 hours of age at the time of consent
- •Infant judged by an attending physician to be likely to die due to the severity of illness
- •Polycythemia
- •Hypertension
- •No in-dwelling line
研究组 & 干预措施
A
All enrolled patients will be in this single arm, who will receive experimental drug treatment.
干预措施: erythropoietin (Drug)
结局指标
主要结局
Serious adverse event
时间窗: 14 days of life
次要结局
- Pharmacokinetic parameters(1 to 11 days of life)
研究者
Yvonne Wu
Professor of Neurology and Pediatrics
University of California, San Francisco