Nitro Oxide Inhalation Continued With Sildenafil on Neonatal Persistent Pulmonary Hypertension

Not Applicable

• Conditions: Persistent Pulmonary Hypertension of Newborn
• Interventions: Drug: NO inhalation; Drug: NO inhalation continued with sildenafil

• Registration Number: NCT01373749
• Lead Sponsor: Third Military Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-01
• Study Start: 2011-03
• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-06-14
• Last Update Submitted: 2011-06-14
• Study First Posted: 2011-06-15
• Last Update Posted: 2011-06-15
• Primary Completion: 2011-12
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NO	NO inhalation	NO inhalation was performed during the whole treatment procedure of PPHN. There is no other methods given to treat PPHN during the therapy course.
NOS	NO inhalation continued with sildenafil	NO inhalation was performed in the first stage(\<48h) of PPHN, NO inhalation was replaced by sildenafil in the second stage(\>48h).

Primary Outcome Measures

Name	Time	Method
persistent normal pulmonary artery pressure	96 hours	The pulmonary artery pressure returned back to a normal level(\<30mmHg) and last over 48 hours.

Secondary Outcome Measures

Name	Time	Method
Recover without complication	1 month after therapy	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.; 1. incidence of pulmonary disease;(chronic lung disease); 2. incidence of brain injury. (Hypoxic-ischemic encephalopathy); 3. Heart structure change(right ventricle enlarge)

Trial Locations

Locations (1)

Department of Pediatrics,Daping hospital; 🇨🇳 Chongqing, Chongqing, China