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临床试验/ACTRN12614000174684
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

发起方
Monash Health Research Directorate

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