Ensayo clínico aleatorizado para evaluar dos pautas de administración del ibuprofeno en el tratamiento del ductus arterioso persistente eco-guiado.

Abstract

Patent ductus arteriosus (PDA) is a common condition of preterm infants and it is associated with significant morbidity and mortality. The best therapeutic option for PDA closure remains controversial. Necrotizing enterocolitis (NEC) and bowel spontaneous perforation have been observed in those infants who received pharmacologic treatment of PDA. Conventional treatment of PDA consists on 3 daily doses of intravenous (iv) ibuprofen in bolus 10-5-5 mg/kg/day. Recently, it has been shown that intravenous continuous infusion of ibuprofen (10-5-5 mg/kg/day) seems to be more effective for PDA closure than the conventional treatment with iv bolus. Our group demonstrated in a recent pilot study that the Echocardiographically guided treatment, EchoG, of PDA when it is compared with the conventional treatment, is feasible and reduces the number of ibuprofen doses. Thus, EchoG treatment potentially reduces the adverse events associated with ibuprofen (i.e lower rate of NEC in the experimental group). This multicenter study will evaluate whether the combination of both experimental therapies (EchoG and iv continuous infusions) reduces the incidence of bowel adverse events (NEC and bowel spontaneous perforation) as compared with EchoG and iv ibuprofen bolus.