ACTRN12614000174684已完成1 期
A pilot study evaluating the safety of intravenously administered human amnion epithelial cells for treatment of bronchopulmonary dysplasia (BPD) in premature babies
Monash Health Research Directorate0 个研究点目标入组 6 人开始时间: 2014年2月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
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
- 36 Weeks 至 o limit(—)
- 性别
- All
入选标准
- •1.Extreme prematurity (less than or equals to 28 weeks gestation at birth)
- •2.At least 36 weeks postmenstrual age
- •3.Ongoing requirement for respiratory support, inclusive of either intubated neonates and non-invasive respiratory support (NIMV/ CPAP) with mean/ end pressure >7 cm H2O
- •4.Stable, yet dependent on respiratory support in terms of oxygen requirement i.e. FiO2 between 0.3 and 0.5.
排除标准
- •Infants who are mechanically ventilated with FiO2 requirement less than 0.3 or more than 0.5.
- •Infants with active infection (who are on intravenous antibiotics)
- •Infants with intercurrent viral illness
- •Infants with severe preterm brain injury (Grade III-IV IVH, cystic PVL)
- •Infants with active necrotizing enterocolitis (NEC)
- •Infants receiving medical or surgical therapy for patent ductus arteriosus (PDA) at the time of enrolment
研究者
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