Early and late outcome of treatment with oral ibuprofen in preterm infants suffering from patent ductus arteriosus: A randomized clinical trial

Background and Objective: Nonsteroidal anti-inflammatory agents are the treatment of choice for ductal closure in premature newborn. This study evaluates early and late outcome, as well as the effectiveness of oral ibuprofen in the treatment of patent ductus arteriosus (PDA) in premature infants. Methods: In this clinical trial, all preterm infants below 37 weeks, with documentation of PDA were enrolled Infants were divided into two groups. The case group (19 patients) was treated with three doses of oral ibuprofen. Control group (19 patients) were under restriction of fluids (serum level of ⅔ maintenance). The rate of ductal closure, presence of pulmonary hypertension were determined at the age of one week, one month, 3 months and 6 months and intraventricular hemorrhage and periventricular leukomalacia (PVL) were detected at the age of one week and one month. The presence of retinopathy was checked at the time of hospital discharge and at the age of one month. Results: Ductal closure was achieved in all newborn of the ibuprofen group whereas in control group ductal closure rate was 16.19 (84.2%) (p=0.23). No case of pulmonary hypertension, PVL or retinopathy was observed in oral ibuprofen group. Regarding to other criteria such as hospital stay, intraventricular hemorrhage, sepsis, ventilator time dependence, pulmonary hemorrhage and mortality rate, no significant difference between the two groups was observed. Conclusions: Oral ibuprofen suspension may be an effective and safe alternative for PDA closure in premature infants. However larger studies are warranted.