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

被引：0
作者：
Carlo Dani
Gianluca Lista
Silvia Bianchi
Fabio Mosca
Federico Schena
Luca Ramenghi
Enrico Zecca
Giovanni Vento
Chiara Poggi
Valentina Leonardi
Diego Minghetti
Maria Teresa Rosignoli
Fabrizio Calisti
Alessandro Comandini
Agnese Cattaneo
Paola Lipone
机构：
[1] Careggi University Hospital of Florence,Department of Neuroscience, Psychology, Drug Research and Child Health
[2] Careggi University Hospital of Florence,Division of Neonatology
[3] “V. Buzzi” Children Hospital of Milan,Division of Neonatology
[4] Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico Milan – NICU,Department of Clinical Sciences and Community Health
[5] University of Milan,Department of Neonatology Obstetrics and Neuroscience
[6] G. Gaslini Children’s University Hospital of Genova,Division of Neonatology
[7] Catholic University of Rome,undefined
[8] Angelini Pharma S.p.A,undefined
来源：
European Journal of Pediatrics | 2021年 / 180卷
关键词：
Paracetamol; Patent ductus arteriosus; Preterm infant;
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摘要：
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.
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页码：807 / 816
页数：9
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