Nitro Oxide Inhalation Continued With Sildenafil on Neonatal Persistent Pulmonary Hypertension
Compare of Continued Nitro Oxide Inhalation and Nitro Oxide Inhalation Continued With Oral Sildenafil on Treatment of Neonatal Persistent Pulmonary Hypertension
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.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Chongqing
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Chongqing、Chongqing、中国、400042
- 招聘中
- Department of Pediatrics,Daping Hospital
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接触：
- Zhangxue Hu, MM
- 电话号码：00862368757730
- 邮箱：huzx1@163.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria: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
Exclusion Criteria:
- congenital heart disease
- diaphragmatic hernia
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：NOS
NO inhalation was performed in the first stage(<48h) of PPHN, NO inhalation was replaced by sildenafil in the second stage(>48h).
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NO inhalation was performed as the primary treatment for PPHN in the first 48 hours, NO inhalation will be replaced by sildenafil after 48 hours of therapy.
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安慰剂比较：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.
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NO inhalation was performed as the only treatment for PPHN during the whole course.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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persistent normal pulmonary artery pressure
大体时间：96 hours
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The pulmonary artery pressure returned back to a normal level(<30mmHg) and last over 48 hours.
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96 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Recover without complication
大体时间：1 month after therapy
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To ensure the safety of the therapies, brain and lung complications of the baby after PPHN is going to be observed 1 month after birth.
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1 month after therapy
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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