Treatment of Patent Ductus Arteriosus with Paracetamol

A persistently patent ductus arteriosus in preterm infants can have negative clinical effects, as left-to-right shunting through the ductus may result in pulmonary overcirculation with increased respiratory distress and hypoperfusion of vital organs. Non Steroidal Anti-Inflammatory Drugs (NSAIDs) represent the conventional pharmacologic treatment for promoting closure of a patent ductus in preterm newborns, but their use has been associated with several adverse effects (reduction in renal, gastrointestinal and cerebral perfusion, renal failure, intestinal perforation, weakened platelet aggregation, hyperbilirubinemia). As an alternative to COX-inhibitors, paracetamol has been recently proposed and used for ductal closure with encouraging results. This drug is commonly used in infants and neonates to treat mild to moderate pain or fever and it seems to be quite free of the adverse effects generally associated with NSAIDs therapy in preterm neonates. In a randomized controlled trial, we would compare efficacy and safety of paracetamol given intravenously with oral route for the treatment of PDA in very preterm infants with contraindication to or failure of conventional medical treatment with COX-inhibitors. Paracetamol efficacy in inducing ductal closure is the primary outcome of the study. Mortality and morbidity of very preterm neonates trated with this drug for PDA and paracetamol safety in this population of neonates are secondary outcomes.