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

A Single Arm Single Centre Study To Investigate Safety And Efficacy Of Sildenafil In Near Term And Term Newborns With Persistent Pulmonary Hypertension Of The Newborn (PPHN)

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

Letter to investigator dated 18 June 2012 that study was to be terminated. Study terminated due to evolved and widespread use of standard of care, relevance of study questioned. No safety reasons or issues.

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