Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension: A Single-Center, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in pulmonary artery systolic pressure
研究概览
简要总结
Neonates with persistent pulmonary hypertension (PPH) should be administered inhaled nitric oxide (iNO) and extracorporeal membrane oxygenation (ECMO), but these are not available in most resource-constrained settings like ours. This study was planned to compare the outcomes of Milrinone plus Sildenafil versus Sildenafil alone in the treatment of PPH in neonates.
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
- None
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either gender
- •Aged between 1-28 days
- •Birth weight above 2000 grams
- •Diagnosed with persistent pulmonary hypertension (as per echocardiography)
排除标准
- •Neonates having congenital heart defects (CHDs)
- •Congenital diaphragmatic hernia
- •Lung anomalies
- •History of any surgical intervention
研究组 & 干预措施
Sildenafil
Patients were given oral sildenafil at 2 mg per kg per day, 6-hourly, with an increment of 0.5 mg per kg per dose and a target maintenance dose of 2 mg per kg per dose every 6 hours by nasogastric tube.
干预措施: Sildenafil (Drug)
Sildenafil + Milrinone
In this group, Milrinone was initiated at 0.5 ug per kg per minute using intravenous infusion through a syringe pump, and sildenafil was given in the same protocol mentioned for the Sildenafil Group.
干预措施: Sildenafil (Drug)
Sildenafil + Milrinone
In this group, Milrinone was initiated at 0.5 ug per kg per minute using intravenous infusion through a syringe pump, and sildenafil was given in the same protocol mentioned for the Sildenafil Group.
干预措施: Milrinone (Drug)
结局指标
主要结局
Change in pulmonary artery systolic pressure
时间窗: 72 hours
Efficacy was labeled yes if there was adecrease in pulmonary artery systolic pressure (PASP)
次要结局
未报告次要终点
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research