Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN)

• Status: Terminated
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Sildenafil is efficacious in newborns with persistent pulmonary hypertension and its use will reduce the need for inhaled nitric oxide.

• 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:

• 72 hours of age; and > or = to 34 weeks gestational age.

• Persistent Pulmonary Hypertension of the Newborn or Hypoxic respiratory failure associated with:

1. Idiopathic PPHN or

2. Meconium aspiration syndrome or

3. Sepsis or

4. Pneumonia

• Oxygenation Index (OI) >15 and <60 calculated

Exclusion Criteria:

• Patients already receiving inhaled nitric oxide (iNO) on referral.

• Prior or immediate need for full Cardio Pulmonary Resuscitation or Extracorporeal Membrane Oxygenation (ECMO).

• Life threatening or lethal congenital anomaly.

• Large left to right intracardiac or ductal shunting (diagnosed from echocardiogram on admission to GOSH).

• Clinically significant active seizures as per clinical judgment.

• Bleeding diathesis as per clinical judgment