Persistent Pulmonary Hypertension of Newborn
Conditions
Keywords
PPHN, NO inhalation, Sildenafil, Treatment, Safety
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.
Interventions
DRUGNO inhalation
NO inhalation was performed as the only treatment for PPHN during the whole course.
DRUGNO 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.
Sponsors
National Natural Science Foundation of China
Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| persistent normal pulmonary artery pressure | 96 hours | The pulmonary artery pressure returned back to a normal level(\<30mmHg) and last over 48 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Contacts
Primary ContactZhangxue Hu, MM
Outcome results
None listed