EUCTR2014-004265-25-NL进行中（未招募）1 期
2-STEP: A single-centre, phase II study to evaluate the safety, tolerability and pharmacokinetics of 2-Iminobiotin (2-IB) in neonates with gestational age of =36 weeks with moderate to severe perinatal asphyxia treated with therapeutic hypothermia
niversity Medical Centre Utrecht0 个研究点开始时间: 2015年1月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Neonates with = 36 and <44 weeks gestation who are eligible to receive therapeutic hypothermia.
- •2.Ability to start treatment within 12 hours after birth.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Inability to insert an indwelling catheter (umbilical venous catheter or percutaneously inserted central catheter, preferably multiple lumen) for administration of the drug or an arterial line for recurrent blood sampling.
- •2.Major congenital malformations, specifically malformations that may affect the renal function.
研究者
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