Milrinone Versus Sildenafil in Treatment of PPHN in Neonates
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- efficacy of milrinone versus sildenafil in treatment of PPHN
研究概览
简要总结
Compare the effect of milrinone versus sildenafil in treatment of neonates with persistent pulmonary hypertension.
详细描述
40 neonates with PPHN, met inclusion criteria, randomly assigned to 2 groups, each includes 20, first group received intravenous milrinone and second group received nasogastric sildenafil. both groups receive other supportive care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 1 Hour 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age >34 weeks
- •postnatal age <10 days
排除标准
- •neonates with congenital heart disease
- •neonates with congenital diaphragmatic hernia
研究组 & 干预措施
milrinone
Milrinone is a phosphodiesterase inhibitor typ3 used in treatment of PPHN. used in dose (0.25 to 0.75 mg/kg/min) intravenous infusion compared with nasogastric sildenafil.
干预措施: Milrinone (Drug)
sildenafil
Sildenafil is a phosphodiesterase inhibitor typ 5 used in treatment of PPHN. used in dose (0.2 to 0.5 mg/kg/6h) by nasogastric tube compared with intravenous milrinone infusion.
干预措施: Sildenafil (Drug)
结局指标
主要结局
efficacy of milrinone versus sildenafil in treatment of PPHN
时间窗: 6 - 12 months
effect on oxygenation index
次要结局
- Ventilatory settings(6-12 months)
- final outcome(6 - 12 months)
- Bleeding(6-12 months)
- Ventilation(6-12 months)
研究者
Rania Ali El-Farrash
assistant professor
Ain Shams University