NCT01360671撤回2 期
An Open Label Single Arm, Single Centre Study to Investigate the Safety and Efficacy of IV Sildenafil in Neonates With Persistent Pulmonary Hypertension of the Newborn (PPHN)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.0 个研究点开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Efficacy - incidence of treatment failure
研究概览
简要总结
To determine the efficacy of iv sildenafil in term and near term infants with PPHN (persistent pulmonary hypertension of the newborn), by measuring the need for inhaled nitric oxide (iNO) or extracorporeal membrane oxygenation (ECMO) compared to a historical control group not treated with sildenafil.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Babies < 72 hours old and at least 34 gestational weeks with PPHN or hypoxic respiratory failure associated with idiopathic PPHN, meconium aspiration, sepsis or pneumonia
- •Oxygenation index >15 and < 60
排除标准
- •Congenital anomaly
- •Large left to right intracardiac or ductal shunt
- •Already on inhaled nitric oxide
研究组 & 干预措施
Sildenafil
Experimental
iv sildenafil
干预措施: Sildenafil (Drug)
结局指标
主要结局
Efficacy - incidence of treatment failure
时间窗: Day 1-14
Need for inhaled nitric oxide or Extracorporeal membrane oxygenation
时间窗: Day 1-14
次要结局
- Changes in oxygenation index(6 & 12 hours)
- Changes in differential saturation(6 & 12 hours)
- Duration of mechanical ventilation(Days 1-14)
- Time from initiation of sildenafil to inhaled nitric oxide or extracorporeal membrane oxygenation(Days 1-14)
研究者
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