DRKS00000102进行中（未招募）未知
Induced systemic hypothermia in asphyxiated new-born infants: a randomised, controlled, multicentre study
Medizinische Universität InnsbruckUniversitätsklinik für Pädiatrie IV0 个研究点目标入组 129 人开始时间: 2009年5月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 129
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 0 Days 至 0 Days（—）
- 性别
- All
入选标准
- •A: Evidence of severe birth asphyxia in infants >= 36 weeks gestation admitted to NICI: one of the following:
- •- Apgar score of <= 5 at 10 minutes after birth
- •- continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth
- •- Acidosis defined as either umbilical cord pH or any arterial pH within 60 minutes of birth < 7.0
- •B: Evidence of encephalopathy (assessed by certified study personnel): moderate to severe encephalopathy
- •C: Evidence of moderate to severe neurophysiological dysfunction by EEG or aEEG
- •D: Consent of at least one parent.
排除标准
- •- Infants expected to be >5.5 hours of age at the time of randomization
- •- prophylactic administration of high dose anticonvulsants
- •- major congenital abnormalities
- •- imperforate anus
- •- evidence of head trauma or skull fracture causing major intracranial hemorrhage
- •- Infants < 1800g birth weight
- •- Head circumference < (mean - 2sd) for gestation
- •- Infants in extremis
- •- overt bleeding
研究者
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