JPRN-jRCT1080224818已完成1 期
Randomized, parallel-group comparative study of JR-031 in infants with neonatal hypoxic ischemic encephalopathy (hereinafter referred to as nHIE) for which hypothermia therapy is indicated
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
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
- •1) An infant diagnosed with nHIE and receiving hypothermia therapy
- •2) An infant whose parent (legal representative) provides written informed consent
排除标准
- •1) An infant with congenital anomaly (e.g., autosomal chromosome anomaly, congenital heart disease, congenital malformation syndrome)
- •2) An infant with severe intracranial hemorrhage as detected by cranial ultrasonography or CT
- •3) An infant with severe infection (e.g., sepsis)
- •4) An infant with hyperkalemia
- •5) An infant whose parent has a history of serious drug allergy or hypersensitivity
- •6) An infant whose mother was treated with another investigational drug or product within 10 months before delivery of the infant
- •7) An infant whose mother was found to be positive for HBs antigen, HCV antibody, or HIV antibody or be serologically positive for syphilis during pregnancy
- •8) An infant who, in the opinion of the investigator or subinvestigator, is not appropriate for the study
研究者
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