IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn

• Status: Withdrawn
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Sildenafil Citrate

Criteria

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