JPRN-jRCTb050200084招募中2 期
Autologous cord blood stem cell therapy for neonatal hypoxic ischemic encephalopathy - Autologous CBSC therapy for neonatal HIE
SHINTAKU HARUO0 个研究点目标入组 15 人开始时间: 2020年11月12日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
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
- 年龄范围
- >= 至 < 1weeks old（—）
- 性别
- All
入选标准
- •At the time of enrollment, subjects who meet all the following selection criteria but do not fall under any of the exclusion criteria are eligible.
- •1. Born over 36 weeks of gestational age.
- •Match one of the following:
- •1) Apgar score of 10 minutes after birth is 5 or less.
- •2) Continuous neonatal resuscitation of 10 minutes or more is necessary.
- •3) Severe acidosis (pH less than 7.0 , or base deficit more than 16 mmol/L in blood gas) at birth (within 1 hour of birth).
- •3. Moderate or severe encephalopathy (Sarnat classification II to III degree) or seizure are recognized.
- •4. Autologous cord blood is collected and stored, and cord blood can be administered within 12~24 hours after birth.
- •5. Written consent has been obtained from the parent of the patient.
排除标准
- •1. Head echo or CT shows severe intracranial hemorrhage.
- •2. Birth weight is less than 1800g.
- •3. Serious infections are occurring.
- •4. After being born outside this research related hospitals, they are ambulanced to the research related hospitals.
- •5 cord blood collection volume is less than 40 ml.
- •6 I am dying and I can not expect the benefit of the child by intensive care including hypothermia. Or, at the discretion of the attending physician, entry into this study may be considered inappropriate.
研究者
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