Compare of Continued Nitro Oxide Inhalation and Nitro Oxide Inhalation Continued With Oral Sildenafil on Treatment of Neonatal Persistent Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- persistent normal pulmonary artery pressure
研究概览
简要总结
Nitro Oxide (NO) inhalation was recognized as an effect treatment of Neonatal Persistent Pulmonary Hypertension (PPHN), while the safety of NO long term application was under investigation. Several research suggested too much NO2 was generated in the lung after long term (> 72h) use of NO inhalation, which cause bad effects on PS production.
Sildenafil was proved to be effective to PPHN as NO. This medication has a similar clinical effect but need monitoring of blood pressure. The possible hypotension effect restrict the dosage of sildenafil, which limit the usage of sildenafil in severe PPHN. But we recommend sildenafil to The purpose of the study was to establish if NO continued with sildenafil has the same effect as single NO inhalation.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as PPHN in the NICU,primary disease:neonate respiratory distress syndrome,meconium aspiration syndrome of newborn,severe neonatal infectious pneumonia.
- •Pulmonary artery pressure > 50mmHg
- •mechanical ventilation over 48h
- •primary OI(PO2/FiO2)<300
- •difference of SpO2 between up and low limbs > 10%
- •high FiO2 oxygen inhalation test: positive
排除标准
- •congenital heart disease
- •diaphragmatic hernia
研究组 & 干预措施
NOS
NO inhalation was performed in the first stage(<48h) of PPHN, NO inhalation was replaced by sildenafil in the second stage(>48h).
干预措施: NO inhalation continued with sildenafil (Drug)
NO
NO inhalation was performed during the whole treatment procedure of PPHN. There is no other methods given to treat PPHN during the therapy course.
干预措施: NO inhalation (Drug)
结局指标
主要结局
persistent normal pulmonary artery pressure
时间窗: 96 hours
The pulmonary artery pressure returned back to a normal level(\<30mmHg) and last over 48 hours.
次要结局
- Recover without complication(1 month after therapy)