Randomised controlled clinical trial of standard versus echocardiographically guided ibuprofen treatment for patent ductus arteriosus in preterm infants: a pilot study.

OBJECTIVE The aim of this study was to explore the efficacy of echocardiographically guided (EchoG) pharmacological closure of the ductus arteriosus in reducing the number of required ibuprofen doses without increasing the reopening rate. METHODS We performed a randomised controlled trial that included 49 infants with a duct ≥1.5 mm who were randomised to either EchoG or standard ibuprofen treatment. Echocardiography was serially performed on days 1, 2, 3, 4, 7, 10 and 17 after inclusion. The primary outcome was the ductus reopening rate, and an intention-to-treat analysis was performed. RESULTS Twenty-eight (EchoG treatment) and 21(standard treatment) infants were enrolled (27.2 versus 27.3 weeks, p = 0.3). The patients received 2 (1-5.7) and 3 (3-4) doses of ibuprofen in the EchoG and standard treatment groups, respectively (p = 0.04) and experienced a similar ductus reopening rate (11% versus 5%, p = 0.6). CONCLUSION Echocardiographically guided ibuprofen treatment of patent ductus arteriosus is feasible and reduces unnecessary doses of medication.