NCT01720524.

Trial name or title	A study to evaluate the safety and efficacy of IV sildenafil in the treatment of neonates with persistent pulmonary hypertension of the newborn
Methods	Multi‐centre randomised placebo‐controlled double‐blind 2‐armed parallel‐group study
Participants	Inclusion criteria: Neonates with persistent pulmonary hypertension of the newborn Age ≤ 96 hours and ≥ 34 weeks' gestational age Oxygenation index > 15 and < 60 Concurrent treatment with inhaled nitric oxide and ≥ 50% oxygen Exclusion criteria: Prior or immediate need for extracorporeal membrane oxygenation or cardiopulmonary resuscitation Expected duration of mechanical ventilation < 48 hours Profound hypoxaemia Life‐threatening or lethal congenital anomaly
Interventions	Treatment: intravenous (IV) sildenafil · Loading dose of 0.1 mg/kg over 30 minutes followed by maintenance dose of 0.03 mg/kg/h. To infuse minimum of 48 hours and maximum of 14 days Control: placebo IV placebo or 0.9% sodium chloride or 10% dextrose. Infusion rate based on weight
Outcomes	Primary outcome measures (at day 14 or until discharge): · Time on inhaled nitric oxide treatment after initiation of IV study drug · Treatment failure rate, defined as need for additional treatment targeting persistent pulmonary hypertension of the newborn Secondary outcome measures: · Time to final weaning off mechanical ventilation for persistent pulmonary hypertension of the newborn · Time from initiation of study drug to treatment failure · Change in oxygenation parameters at 6, 12, and 24 hours from baseline · Sildenafil plasma concentrations and corresponding pharmacokinetic (PK) parameters · Safety parameters: incidence and severity of adverse events and abnormal laboratory parameters Long‐term outcomes (12 and 24 months): · Developmental progress of participants as assessed by Bayley Scales of Infant Development and Behavior Questionnaire · Safety as assessed by adverse events and survival · Neurological progress of participants as assessed by the Neurology Optimality Score, also known as the Hammersmith Infant Neurological Examination · Visual status of participants as assessed by eye examination of anterior and posterior segments · Audiological status of participants as assessed by physiological and behavioural tests
Starting date	17 September 2012
Contact information	Pfizer CT.gov call centre: 1‐800‐718‐1021
Notes	Includes a long‐term follow‐up investigation of developmental progress at 12 and 24 months