Our aim was to assess the efficacy and safety of intravenous (i.v.)
paracetamol vs. i.v.
ibuprofen for the treatment of hemodynamically significant
patent ductus arteriosus (hsPDA) in preterm infants. This is a multicenter randomized controlled study. Infants with a gestational age of 25+0-31+6 weeks were randomized to receive i.v.
paracetamol (15 mg/kg/6 h for 3 days) or i.v.
ibuprofen (10-5-5 mg/kg/day). The primary outcome was the closure rate of hsPDA after the first treatment course with
paracetamol or
ibuprofen. Secondary outcomes included the constriction rate of hsPDA, the re-opening rate, and the need for surgical closure. Fifty-two and 49 infants received
paracetamol or
ibuprofen, respectively.
Paracetamol was less effective in closing hsPDA than
ibuprofen (52 vs. 78%; P = 0.026), but the constriction rate of the ductus was similar (81 vs. 90%; P = 0.202), as confirmed by logistic regression analysis. The re-opening rate, the need for surgical closure, and the occurrence of adverse effects were also similar.Conclusions: Intravenous
paracetamol was less effective in closing hsPDA than
ibuprofen, but due to a similar constriction effect, its use was associated with the same hsPDA outcome. These results can support the use of i.v.
paracetamol as a first-choice
drug for the treatment of hsPDA.Trial registration: Clinicaltrials.gov : NCT02422966, Date of registration: 04/09/2015; EudraCT no: 2013-003883-30. What is Known: • The successful closure of
patent ductus arteriosus with oral
paracetamol has been recently reported in several preterm infants, but only one randomized controlled study investigated the efficacy of intravenous
paracetamol. What is New: • Intravenous
paracetamol is less effective in closing hsPDA than
ibuprofen, but have a similar constriction effect. • These results can support the use of i.v.
paracetamol as a first-choice
drug for the treatment of hsPDA.