Treatment strategy of patent ductus arteriosus in preterm infants

Abstract

Objective – This study was to assess the efficacy and safety of oral ibuprofen and intravenous ibuprofen for the early pharmacological treatment of patent ductus arteriosus (PDA) in preterm infants. Methods – A randomized, single-blinded, controlled study was performed on premature neonates at the neonatal unit tertiary care hospital, from January 2010 to December 2012. The study enrolled 80 preterm infants with gestational age between 28-32 weeks, birth weight ≤ 2000 g, postnatal age 48-96 h, and with echocardiographically confirmed significant PDA (a duct size >1.5 mm). The preterm infants received either intravenous or oral ibuprofen randomly as an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h after the first dose (the first treatment course). Serum creatinine (sCr), blood urea nitrogen (BUN) and urine output (UO) were recorded prior to treatment, before each dose and after the first treatment course. Results – Forty patients were treated with oral ibuprofen and 40 with intravenous ibuprofen in this period. There was no difference between treatment groups in demographics or baseline renal function. After the first course of the treatment, the PDA closed in 28 (70%) of the patients assigned to the oral ibuprofen group, versus 23 (57.5%) of those enrolled in the intravenous ibuprofen group (p=0.35). In the evaluation of renal tolerance, none of the patients had oliguria. Moreover, in patients who underwent a second course of intravenous therapy, the urinary output significantly decreased, but the sCr levels after the first and after the second treatment course did not differ significantly from the baseline for each group. 7.5% of the intravenous group underwent surgery, versus 0% of the oral group. (p=0.23) Conclusions – Successful pharmacological closure of PDA can be achieved by the use of ibuprofen orally or intravenously, without statistically significant difference in efficacy and safety between the two treatments. Patients treated with ibuprofen intravenously probably have a much higher risk of undergoing surgery.