Compare of Continued Nitro Oxide Inhalation and Nitro Oxide Inhalation Continued With Oral Sildenafil on Treatment of Neonatal Persistent Pulmonary Hypertension
Overview
- Phase
- Not Applicable
- Intervention
- NO inhalation continued with sildenafil
- Conditions
- Persistent Pulmonary Hypertension of Newborn
- Sponsor
- Third Military Medical University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- persistent normal pulmonary artery pressure
- Last Updated
- 14 years ago
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.
Investigators
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
Arms & Interventions
NOS
NO inhalation was performed in the first stage(\<48h) of PPHN, NO inhalation was replaced by sildenafil in the second stage(\>48h).
Intervention: NO inhalation continued with sildenafil
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.
Intervention: NO inhalation
Outcomes
Primary Outcomes
persistent normal pulmonary artery pressure
Time Frame: 96 hours
The pulmonary artery pressure returned back to a normal level(\<30mmHg) and last over 48 hours.
Secondary Outcomes
- Recover without complication(1 month after therapy)