Efficacy of intravenous paracetamol compared to placebo in the prevention of patent ductus arteriosus in very preterm newborns

Abstract

PDA. OBJECTIVE : The purpose of the present study is to determine the efficacy of paracetamol in the prevention of PDA in comparison to placebo in very preterm newborns. Safety of paracetamol will also be assessed. DESIGN AND SETTING : A triple-blinded randomized trial will be performed among the Neonatal Intensive Care Units (NICUs) of Hospital universitari Dr. Josep Trueta in Girona and Hospital universitari Vall d’Hebron in Barcelona. PARTICIPANTS, INTERVENTION AND METHOD: A total of 336 prematures under 32 weeks of gestation will be randomized into one of the two treatment groups. One group will be receiving paracetamol (loading dose of 20 mg/kg followed by a maintenance dose of 7.5 mg/kg/6h) while the other group will receive placebo. Follow-up echocardiographies will be held on day three and seven after beginning of treatment, as well as on month one and three, to asses the presence or not of PDA, which will be the main outcome. Physical exploration, blood analysis and transfontanellar echographies will be held regularly to evaluate drug adverse effects and comorbidities, to assess secondary outcomes