Abstract
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.
Highlights
Materials and methodsPatent ductus arteriosus (PDA) is a frequent complication in preterm infants with respiratory distress syndrome (RDS), and 60–70% of preterm infants of < 28-week gestation receive medical and/or surgical treatment for PDA [1]
Intravenous paracetamol was less effective in closing hemodynamically significant patent ductus arteriosus (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
Summary
Materials and methodsPatent ductus arteriosus (PDA) is a frequent complication in preterm infants with respiratory distress syndrome (RDS), and 60–70% of preterm infants of < 28-week gestation receive medical and/or surgical treatment for PDA [1]. A persistent left-to-right shunt through the ductus arteriosus (DA) complicating RDS has been associated with a worsening of respiratory failure, lowering of survival rate, increased risk of intraventricular hemorrhage (IVH), and bronchopulmonary dysplasia (BPD) [1, 3,4,5,6]. The current treatment of PDA encompasses two steps: the first is the pharmacological treatment with a NSAID; the second, in case of medical treatment failure, is the surgical ligation, which should be avoided, if possible, due to the associated severe complications [7]. Standard medical therapy for the PDA closure mainly involves either indomethacin or ibuprofen. Both are successful in promoting the ductal closure in 70–80% of cases [8, 9]. Ibuprofen appears to be at present the drug of choice for PDA pharmacological closure, due to its fewer side effects compared with indomethacin [9], it does not represent the ideal drug because of its sub-optimal safety profile [9] and because of its approximately 30% failure rate [10, 11]
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