EUCTR2015-003063-12-Outside-EU/EEA进行中（未招募）1 期
TIBC study:A multiple-centre Phase 2 trial comparing the efficacy of 2-Iminobiotin (2-IB) treatment to standard care in neonates with gestational age of =36 weeks with moderate to severe perinatal asphyxia in DR Congo. - TIBC
europhyxia B.V.0 个研究点目标入组 94 人开始时间: 2016年9月14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
- 入组人数
- 94
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 weeks gestation with moderate to severe perinatal asphyxia with a Thompson score = 7 within 6h after birth
- •Ability to start treatment within 6 hours after birth
- •2.Ability to start treatment within 6 hours after birth
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 94
- •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 umbilical venous catheter for administration of the study drug.
- •2. Major congenital or chromosomal abnormalities, such as hernia diaphragmatica, omphalocele, trisomy 13 or trisomy 18
- •3. Birth weight < 1800 grams
- •4. Clear signs of infection
- •5. Moribund patients
研究者
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