ACTRN12623001352695尚未招募Unknown
Safety and Feasibility of Allogeneic Cord Blood-Derived Cell Therapy in Preterm Infants with Severe Brain Injury (ALLO Trial)
Monash Children's Hospital0 个研究点目标入组 20 人开始时间: 2023年12月21日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 22 Weeks 至 36 Weeks（—）
- 性别
- All
入选标准
- •1. Preterm infants born before 28 completed weeks of gestation (up to 27+6 weeks, ALLO-1 trial) OR born between 28 and 36+6 weeks of gestation (ALLO-2 trial) AND
- •2. Severe brain injury detected on neonatal neuroimaging any time after birth. A severe brain injury will be considered as grade 3 (intraventricular haemorrhage with ventricular distension) or 4 (parenchymal haemorrhagic infarct) IVH and diffuse cystic (grade 3) periventricular leucomalacia.
排除标准
- •1. Infants with known major congenital anomalies
- •2. Infants whose care is being redirected to comfort care.
- •Cell therapy will only be administered when preterm infants are clinically stable, which is deemed by the treating physician. Also, infants should not be receiving antimicrobial therapy for confirmed or presumed late-onset neonatal sepsis at the time of cell infusion as their course may be unpredictable and may confound adverse events falsely attributing to the cell therapy.
研究者
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