Nitro Oxide Inhalation Continued With Sildenafil on Neonatal Persistent Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Compare of Continued Nitro Oxide Inhalation and Nitro Oxide Inhalation Continued With Oral Sildenafil on Treatment of Neonatal Persistent Pulmonary Hypertension

Conditions
-----------------
Persistent Pulmonary Hypertension of Newborn

Intervention / Treatment
-----------------
* Drug: NO inhalation
* Drug: NO inhalation continued with sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Maximum Age: 28 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NOS<br>NO inhalation was performed in the first stage(<48h) of PPHN, NO inhalation was replaced by sildenafil in the second stage(>48h). | Drug: NO inhalation continued with sildenafil<br>* 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.<br>|
| Placebo Comparator: NO<br>NO inhalation was performed during the whole treatment procedure of PPHN. There is no other methods given to treat PPHN during the therapy course. | Drug: NO inhalation<br>* NO inhalation was performed as the only treatment for PPHN during the whole course.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| persistent normal pulmonary artery pressure | The pulmonary artery pressure returned back to a normal level(<30mmHg) and last over 48 hours. | 96 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recover without complication | 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. incidence of pulmonary disease;(chronic lung disease) incidence of brain injury. (Hypoxic-ischemic encephalopathy) Heart structure change(right ventricle enlarge) | 1 month after therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PPHN, NO inhalation, Sildenafil, Treatment, Safety