Persistent Pulmonary Hypertension of the Newborn
Conditions
Keywords
PPHN, persistent pulmonary hypertension of the newborn, sildenafil, iv
Brief summary
To determine the efficacy of iv sildenafil in term and near term infants with PPHN (persistent pulmonary hypertension of the newborn), by measuring the need for inhaled nitric oxide (iNO) or extracorporeal membrane oxygenation (ECMO) compared to a historical control group not treated with sildenafil.
Interventions
DRUGSildenafil
Loading dose of 0.1 mg/kg for 30 minutes followed by maintenance treatment of 0.03 mg/kg.h for up to 14 days
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 72 Hours
Healthy volunteers
No
Inclusion criteria
* Babies \< 72 hours old and at least 34 gestational weeks with PPHN or hypoxic respiratory failure associated with idiopathic PPHN, meconium aspiration, sepsis or pneumonia * Oxygenation index \>15 and \< 60
Exclusion criteria
* Congenital anomaly * Large left to right intracardiac or ductal shunt * Already on inhaled nitric oxide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy - incidence of treatment failure | Day 1-14 |
| Need for inhaled nitric oxide or Extracorporeal membrane oxygenation | Day 1-14 |
Secondary
| Measure | Time frame |
|---|---|
| Changes in oxygenation index | 6 & 12 hours |
| Changes in differential saturation | 6 & 12 hours |
| Duration of mechanical ventilation | Days 1-14 |
| Time from initiation of sildenafil to inhaled nitric oxide or extracorporeal membrane oxygenation | Days 1-14 |
Outcome results
None listed