Clinical Trial: IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: An Open Label Single Arm, Single Centre Study to Investigate the Safety and Efficacy of IV Sildenafil in Neonates With Persistent Pulmonary Hypertension of the Newborn (PP

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.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • Efficacy - incidence of treatment failure [ Time Frame: Day 1-14 ]
  • Need for inhaled nitric oxide or Extracorporeal membrane oxygenation [ Time Frame: Day 1-14 ]


Original Primary Outcome: Measure of Efficacy by the incidence of treatment failure in patients. [ Time Frame: Follow daily days 1-14 ]

The incidence of treatment failure is measure by the patietns need for inhaled nitric oxide (iNO) or ECMO.


Current Secondary Outcome:

  • Changes in oxygenation index [ Time Frame: 6 & 12 hours ]
  • Changes in differential saturation [ Time Frame: 6 & 12 hours ]
  • Duration of mechanical ventilation [ Time Frame: Days 1-14 ]
  • Time from initiation of sildenafil to inhaled nitric oxide or extracorporeal membrane oxygenation [ Time Frame: Days 1-14 ]


Original Secondary Outcome:

  • Changes in oxygenation index (OI) from baseline. [ Time Frame: 6 & 12 hours from baseline ]
  • Changes in differential saturation from baseline. [ Time Frame: 6 & 12 hours from baseline ]
    pre- and post-ductal
  • Duration (in days) of mechanical ventilation [ Time Frame: Follow daily days 1-14 ]
  • Time from initiation of sildenafil to receipt of additional standard therapy (inhaled nitric oxide or extracorporeal membrane oxygenation) [ Time Frame: Follow daily days 1-14 ]


Information By: Pfizer

Dates:
Date Received: May 10, 2011
Date Started: March 2012
Date Completion: April 2013
Last Updated: May 24, 2012
Last Verified: May 2012