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Paracetamol for the treatment of patent ductus arteriosus in preterm neonates: a systematic review and meta-analysis
  1. Gianluca Terrin1,
  2. Francesca Conte2,
  3. Mehmet Yekta Oncel3,
  4. Antonella Scipione2,
  5. Patrick J McNamara4,
  6. Sinno Simons5,
  7. Rahul Sinha6,
  8. Omer Erdeve7,
  9. Kadir S Tekgunduz8,
  10. Mustafa Dogan9,
  11. Irena Kessel10,
  12. Cathy Hammerman11,
  13. E Nadir12,
  14. Sadik Yurttutan3,
  15. Bonny Jasani13,
  16. Serdar Alan14,
  17. Francesco Manguso15,
  18. Mario De Curtis2
  1. 1Department of Gynecology-Obstetrics and Perinatal Medicine, Sapienza University of Rome, Rome, Italy
  2. 2Department of Pediatrics and Pediatric Neuropsychiatry, Sapienza University of Rome, Rome, Italy
  3. 3Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey
  4. 4Department of Neonatology, The Hospital for Sick Children, Toronto, Canada
  5. 5Division of Neonatology, Department of Pediatrics, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands
  6. 6Department of Pediatrics and Neonatology, 167 Military Hospital, Pathankot, Punjab, India
  7. 7Division of Neonatology, Department of Pediatrics, Ankara University School of Medicine Children's Hospital, Ankara, Turkey
  8. 8Department of Neonatology, Ataturk University Medical Faculty, Erzurum, Turkey
  9. 9Division of Cardiology, Department of Pediatrics, Pamukkale University, Denizli, Turkey
  10. 10Department of Neonatology, Carmel Medical Center, Haifa, Israel
  11. 11Department of Neonatology, Shaare Zedek Medical Center, Hebrew University, Jerusalem, Israel
  12. 12Department of Neonatology, Hillel Yaffe Medical Center, Hadera, Israel
  13. 13Department of Neonatology, KEM Hospital, Mumbai, India
  14. 14Division of Neonatology, Hitit University, Corum, Turkey
  15. 15Division of Gastroenterology, Cardarelli Hospital, Naples, Italy
  1. Correspondence to Dr Gianluca Terrin, Department of Gynecology-Obstetrics and Perinatal Medicine, Sapienza University of Rome, Viale del Policlinico 155, Rome 00161, Italy; gianluca.terrin{at}uniroma1.it

Abstract

Objectives 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.

Data source 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.

Study selection Studies comparing paracetamol versus ibuprofen, indomethacin, placebo or no intervention for the treatment of PDA.

Data extraction Data regarding efficacy and safety were collected and analysed.

Results 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.

Conclusions 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.

  • Neonatology
  • Cardiology
  • Intensive Care
  • Therapeutics

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