CTRI/2016/01/006534招募中3 期
Hypothermia for Encephalopathy in Low and Middle Income Countries Trial - HELIX
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 408
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion Criteria (ALL THE THREE BELOW)
- •1.Age < 6 hours, Birth-weight >1.8 kg, Gestation >36 weeks
- •2.Need for continued resuscitation at 5 minutes after birth and/or 5 minute Apgar score <6 (in babies born at hospital) or lack of cry by 5 minutes of age (for babies born at home)
- •3.Evidence of moderate or severe encephalopathy on clinical examination within 6 hours of age.
排除标准
- •Exclusion Criteria
- •1.Absent heart rate at 10 minute of age despite adequate resuscitation.
- •2.Major life threatening congenital malformation.
- •3.Migrant family or parents unable/unlikely to come back for follow up at 18 months.
- •4.Lack of parental consent.
研究者
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