Norepinephrine versus Vasopressin in Persistent Pulmonary Hypertension of the Newborn : Randomized controlled trial

Persistent pulmonary hypertension of the newborn is a life threatening condition in term and late preterm babies where high pulmonary pressure causes poor oxygenation and low blood pressure. Norepinephrine and vasopressin are two commonly used vasopressors in neonatal intensive care units but there is limited evidence comparing their effectiveness and safety in this condition. The NOVA PPHN trial is a single center randomized controlled open label study with blinded outcome assessment conducted at Rainbow Childrens Hospital Vijayawada. Term and late preterm neonates of 34 weeks or more gestation with confirmed PPHN and systemic hypotension requiring vasopressor support will be enrolled. Eligible babies will be randomly assigned to receive norepinephrine or vasopressin infusion along with standard supportive care including ventilation and nitric oxide as needed. The primary outcome is change in oxygenation index from baseline to 12 hours after starting study drug. Secondary outcomes include mean arterial pressure, need for rescue drugs, duration of ventilation, nitric oxide requirement, echocardiographic findings, biochemical safety parameters and mortality before discharge. The study duration is 36 months. This investigator initiated phase four clinical trial aims to identify the safer and more effective first line vasopressor for managing PPHN in newborns.