Nitro Oxide Inhalation Continued With Sildenafil on Neonatal Persistent Pulmonary Hypertension

Persistent Pulmonary Hypertension of Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01373749
• Other study ID #: 1991660
• Status: Recruiting
• Phase: N/A
• First received: May 31, 2011
• Last updated: June 14, 2011
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: January 2011
• Source: Third Military Medical University
• Contact: Zhangxue Hu, MM
• Phone: 00862368757730
• Email: huzx1[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Persistent Fetal Circulation Syndrome
• Persistent Pulmonary Hypertension of Newborn
• Respiratory Aspiration

Intervention

Drug:
• NO inhalation
NO inhalation was performed as the only treatment for PPHN during the whole course.
• NO inhalation continued with sildenafil
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.

Locations

Country	Name	City	State
China	Department of Pediatrics,Daping hospital	Chongqing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Third Military Medical University	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	persistent normal pulmonary artery pressure	The pulmonary artery pressure returned back to a normal level(<30mmHg) and last over 48 hours.	96 hours	Yes
Secondary	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	Yes