Oral ibuprofen is superior to oral paracetamol for patent ductus arteriosus in very low and extremely low birth weight infants

Paracetamol (acetaminophen) has been proposed as an alternative medication for closing hemodynamically significant patent ductus arteriosus (PDA). However, the clinical outcomes remain inconclusive in very low birth weight (VLBW) and extremely low birth weight (ELBW) infants. The aim of this study was to compare the efficacy and safety of oral paracetamol and ibuprofen for pharmacological closure of PDA in premature infants from a real-world study. This retrospective study enrolled 255 preterm infants with birthweights of <= 1.5 kg, and echocardiographically confirmed significant PDA. Subjects were classified into 3 groups: Group I (standard-dose ibuprofen group) received 10mg/kg oral ibuprofen followed by 5mg/kg/day for 2 days. Group II (high-dose ibuprofen group) received 10mg/kg/day oral ibuprofen for 3 days. Group III (paracetamol group) received 15mg/kg/6h oral paracetamol for 3 days. On day 9 after medication start, PDA closure was achieved in 61 (71.7%) patients assigned to the high-dose ibuprofen group, (63.8%) in the standard-dose ibuprofen group, and 33 (37.9%) of those in the oral paracetamol group (P < .001). Oral standard-dose ibuprofen was more effective than oral paracetamol (P = .001). The ductus closed faster in the high-dose ibuprofen group than in the standard-dose group (median closure time 3.9 +/- 1.0 versus 4.4 +/- 1.0 days, P = .009). Total bilirubin significantly increased in the high-dose ibuprofen group (P = .02). No gastrointestinal, renal, or hematological adverse effects were reported. Subgroup analyses indicated paracetamol was minimally effective in ELBW infants (PDA closure 13%). This study demonstrated that paracetamol may be a poor medical alternative for PDA management in VLBW and ELBW infants. High dosage ibuprofen was associated with a faster clinical improvement and higher rate of PDA closure.