Paracetamol for the treatment of patent ductus arteriosus in preterm neonates: a systematic review and meta-analysis

Gianluca Terrin; Francesca Conte; Mehmet Yekta Oncel; Antonella Scipione; Patrick J McNamara; Sinno Simons; Rahul Sinha; Omer Erdeve; Kadir S Tekgunduz; Mustafa Dogan; Irena Kessel; Cathy Hammerman; E Nadir; Sadik Yurttutan; Bonny Jasani; Serdar Alan; Francesco Manguso; Mario De Curtis

doi:10.1136/archdischild-2014-307312

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Paracetamol for the treatment of patent ductus arteriosus in preterm neonates: a systematic review and meta-analysis

Journal article

Peer reviewed

Paracetamol for the treatment of patent ductus arteriosus in preterm neonates: a systematic review and meta-analysis

Gianluca Terrin, Francesca Conte, Mehmet Yekta Oncel, Antonella Scipione, Patrick J McNamara, Sinno Simons, Rahul Sinha, Omer Erdeve, Kadir S Tekgunduz, Mustafa Dogan, …

Archives of disease in childhood. Fetal and neonatal edition, Vol.101(2), pp.F127-F136

03/2016

DOI: 10.1136/archdischild-2014-307312

PMID: 26283668

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https://hdl.handle.net/11491/1503View

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Abstract

We performed a systematic review and meta-analysis of all the available evidence to assess the efficacy and safety of paracetamol for the treatment of patent ductus arteriosus (PDA) in neonates, and to explore the effects of clinical variables on the risk of closure. MEDLINE, Scopus and ISI Web of Knowledge databases, using the following medical subject headings and terms: paracetamol, acetaminophen and patent ductus arteriosus. Electronic and manual screening of conference abstracts from international meetings of relevant organisations. Manual search of the reference lists of all eligible articles. Studies comparing paracetamol versus ibuprofen, indomethacin, placebo or no intervention for the treatment of PDA. Data regarding efficacy and safety were collected and analysed. Sixteen studies were included: 2 randomised controlled trials (RCTs) and 14 uncontrolled studies. Quality of selected studies is poor. A meta-analysis of RCTs does not demonstrate any difference in the risk of ductal closure (Mantel-Haenszel model, RR 1.07, 95% CI 0.87 to 1.33 and RR 1.03, 95% CI 0.92 to 1.16, after 3 and 6 days of treatment, respectively). Proportion meta-analysis of uncontrolled studies demonstrates a pooled ductal closure rate of 49% (95% CI 29% to 69%) and 76% (95% CI 61% to 88%) after 3 and 6 days of treatment with paracetamol, respectively. Safety profiles of paracetamol and ibuprofen are similar. Efficacy and safety of paracetamol appear to be comparable with those of ibuprofen. These results should be interpreted with caution, taking into account the non-optimal quality of the studies analysed and the limited number of neonates treated with paracetamol so far.

Ibuprofen - therapeutic use

Ductus Arteriosus, Patent - drug therapy

Humans

Infant, Premature

Acetaminophen - therapeutic use

Cyclooxygenase Inhibitors - therapeutic use

Infant, Newborn

Details

Title: Subtitle: Paracetamol for the treatment of patent ductus arteriosus in preterm neonates: a systematic review and meta-analysis
Creators: Gianluca Terrin - Department of Gynecology-Obstetrics and Perinatal Medicine, Sapienza University of Rome, Rome, Italy
Francesca Conte - Department of Pediatrics and Pediatric Neuropsychiatry, Sapienza University of Rome, Rome, Italy
Mehmet Yekta Oncel - Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey
Antonella Scipione - Department of Pediatrics and Pediatric Neuropsychiatry, Sapienza University of Rome, Rome, Italy
Patrick J McNamara - Department of Neonatology, The Hospital for Sick Children, Toronto, Canada
Sinno Simons - Division of Neonatology, Department of Pediatrics, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands
Rahul Sinha - Department of Pediatrics and Neonatology, 167 Military Hospital, Pathankot, Punjab, India
Omer Erdeve - Division of Neonatology, Department of Pediatrics, Ankara University School of Medicine Children's Hospital, Ankara, Turkey
Kadir S Tekgunduz - Department of Neonatology, Ataturk University Medical Faculty, Erzurum, Turkey
Mustafa Dogan - Division of Cardiology, Department of Pediatrics, Pamukkale University, Denizli, Turkey
Irena Kessel - Department of Neonatology, Carmel Medical Center, Haifa, Israel
Cathy Hammerman - Department of Neonatology, Shaare Zedek Medical Center, Hebrew University, Jerusalem, Israel
E Nadir - Department of Neonatology, Hillel Yaffe Medical Center, Hadera, Israel
Sadik Yurttutan - Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey
Bonny Jasani - Department of Neonatology, KEM Hospital, Mumbai, India
Serdar Alan - Division of Neonatology, Hitit University, Corum, Turkey
Francesco Manguso - Division of Gastroenterology, Cardarelli Hospital, Naples, Italy
Mario De Curtis - Department of Pediatrics and Pediatric Neuropsychiatry, Sapienza University of Rome, Rome, Italy
Resource Type: Journal article
Publication Details: Archives of disease in childhood. Fetal and neonatal edition, Vol.101(2), pp.F127-F136
DOI: 10.1136/archdischild-2014-307312
PMID: 26283668
NLM abbreviation: Arch Dis Child Fetal Neonatal Ed
ISSN: 1359-2998
eISSN: 1468-2052
Language: English
Date published: 03/2016
Academic Unit: Stead Family Department of Pediatrics; Neonatology; Internal Medicine
Record Identifier: 9984093605702771

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