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Intravenous paracetamol in comparison with ibuprofen for the treatment of patent ductus arteriosus in preterm infants: a randomized controlled trial.

Authors
  • Dani, Carlo1, 2
  • Lista, Gianluca3
  • Bianchi, Silvia3
  • Mosca, Fabio4, 5
  • Schena, Federico4
  • Ramenghi, Luca6
  • Zecca, Enrico7
  • Vento, Giovanni7
  • Poggi, Chiara8
  • Leonardi, Valentina8
  • Minghetti, Diego6
  • Rosignoli, Maria Teresa9
  • Calisti, Fabrizio9
  • Comandini, Alessandro9
  • Cattaneo, Agnese9
  • Lipone, Paola9
  • 1 Department of Neuroscience, Psychology, Drug Research and Child Health, Careggi University Hospital of Florence, Largo Brambilla 3, 50134, Florence, Italy. [email protected] , (Italy)
  • 2 Division of Neonatology, Careggi University Hospital of Florence, Largo Brambilla 3, 50134, Florence, Italy. [email protected] , (Italy)
  • 3 Division of Neonatology, "V. Buzzi" Children Hospital of Milan, Via Castelvetro 22, 20154, Milan, Italy. , (Italy)
  • 4 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan - NICU, Via Della Commenda 12, 20122, Milan, Italy. , (Italy)
  • 5 Department of Clinical Sciences and Community Health, University of Milan, Via Della Commenda 12, 20122, Milan, Italy. , (Italy)
  • 6 Department of Neonatology Obstetrics and Neuroscience, G. Gaslini Children's University Hospital of Genova, Via Gerolamo Gaslini 5, 16147, Genoa, Italy. , (Italy)
  • 7 Division of Neonatology, Catholic University of Rome, Largo Agostino Gemelli 8, 00168, Rome, Italy. , (Italy)
  • 8 Division of Neonatology, Careggi University Hospital of Florence, Largo Brambilla 3, 50134, Florence, Italy. , (Italy)
  • 9 Angelini Pharma S.p.A, Viale Amelia 70, 00181, Rome, Italy. , (Italy)
Type
Published Article
Journal
European Journal of Pediatrics
Publisher
Springer-Verlag
Publication Date
Mar 01, 2021
Volume
180
Issue
3
Pages
807–816
Identifiers
DOI: 10.1007/s00431-020-03780-8
PMID: 32888085
Source
Medline
Keywords
Language
English
License
Unknown

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.

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