Clinical Trial: Oral Sildenafil in Persistent Pulmonary Hypertension Secondary to Meconium Aspiration Syndrome in Newborns

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Oral Sildenafil in Persistent Pulmonary Hypertension Secondary to Meconium Aspiration Syndrome in Newborns: A Randomized Placebo Controlled Trial

Brief Summary: The purpose of this study is to to study the role of oral Sildenafil in Persistent Pulmonary Hypertension of Newborn (PPHN) secondary to Meconium Aspiration Syndrome (MAS) in newborns and to study risk factors of MAS developing into PPHN.

Detailed Summary:
Sponsor: Sir Takhtasinhji General Hospital

Current Primary Outcome: Improvement in oxygen saturation (SpO2) [ Time Frame: 26 hours, 50 hours ]

Preductal and postductal oxygen saturation (SpO2) 2 hours after dose of oral sildenafil (24 hours and 48 hours)


Original Primary Outcome: Same as current

Current Secondary Outcome: Oxygenation index [ Time Frame: 26 hours, 50 hours ]

Oxygenation index of neonates kept on ventilator 2 hours after dose of oral sildenafil (24 hours and 48 hours) [Oxygenation index (OI) = Mean airway pressure (cm H2O) × FiO2 × 100/ PaO2 [fraction of inspired oxygen- FiO2] [Arterial partial pressure of oxygen- PaO2]


Original Secondary Outcome: Same as current

Information By: Sir Takhtasinhji General Hospital

Dates:
Date Received: December 18, 2012
Date Started: December 2011
Date Completion:
Last Updated: June 24, 2014
Last Verified: June 2014