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Am J Perinatol 2018; 35(13): 1319-1325
DOI: 10.1055/s-0038-1653946
Original Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Adding Paracetamol to Ibuprofen for the Treatment of Patent Ductus Arteriosus in Preterm Infants: A Double-Blind, Randomized, Placebo-Controlled Pilot Study

Authors

  • Ori Hochwald

    1   Neonatal Intensive Care Unit, Ruth Rappaport Children's Hospital, Rambam Health Campus, Rappoart Faculty of Medicine, Technion, Haifa, Israel

  • Gur Mainzer

    2   Department of Pediatric Cardiology and Congenital Heart Disease in Adults, Ruth Rappaport Children's Hospital, Rambam Health Campus, Rappoart Faculty of Medicine, Technion, Haifa, Israel
    3   Department of Pediatric Cardiology, Baruch Padeh Medical Center, Poriya, Israel

  • Liron Borenstein-Levin

    1   Neonatal Intensive Care Unit, Ruth Rappaport Children's Hospital, Rambam Health Campus, Rappoart Faculty of Medicine, Technion, Haifa, Israel

  • Huda Jubran

    1   Neonatal Intensive Care Unit, Ruth Rappaport Children's Hospital, Rambam Health Campus, Rappoart Faculty of Medicine, Technion, Haifa, Israel

  • Gil Dinur

    1   Neonatal Intensive Care Unit, Ruth Rappaport Children's Hospital, Rambam Health Campus, Rappoart Faculty of Medicine, Technion, Haifa, Israel

  • Meirav Zucker

    2   Department of Pediatric Cardiology and Congenital Heart Disease in Adults, Ruth Rappaport Children's Hospital, Rambam Health Campus, Rappoart Faculty of Medicine, Technion, Haifa, Israel

  • Malka Mor

    1   Neonatal Intensive Care Unit, Ruth Rappaport Children's Hospital, Rambam Health Campus, Rappoart Faculty of Medicine, Technion, Haifa, Israel

  • Asaad Khoury

    2   Department of Pediatric Cardiology and Congenital Heart Disease in Adults, Ruth Rappaport Children's Hospital, Rambam Health Campus, Rappoart Faculty of Medicine, Technion, Haifa, Israel

  • Amir Kugelman

    1   Neonatal Intensive Care Unit, Ruth Rappaport Children's Hospital, Rambam Health Campus, Rappoart Faculty of Medicine, Technion, Haifa, Israel

Funding None.
Further Information

Publication History

12 March 2018

06 April 2018

Publication Date:
21 May 2018 (online)

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Abstract

Objective The objective of this study was to compare the closure rate of hemodynamically significant patent ductus arteriosus (hsPDA) of intravenous ibuprofen + paracetamol (acetaminophen) versus ibuprofen + placebo, in preterm infants of 24 to 316/7 weeks postmenstrual age.

Study Design This is a single-center, double-blind, randomized controlled pilot study. Infants were assigned for treatment with either intravenous ibuprofen + paracetamol (n = 12) or ibuprofen + placebo (n = 12).

Results There was no statistical difference in baseline characteristics of the two groups. Echocardiography parameters were comparable before treatment in both groups. There was a trend toward higher hsPDA closure rate in the paracetamol group in comparison to the placebo group (83 vs. 42%, p = 0.08). No adverse effects, clinical or laboratory, were associated with adding paracetamol.

Conclusion Our pilot study was unable to detect a beneficial effect by adding intravenous paracetamol to ibuprofen for the treatment of hsPDA. Larger prospective studies are needed to explore the positive tendency suggested by our results and to assure safety.

Keywords

nonsteroidal anti-inflammatory drugs - premature - neonate - hemodynamically significant patent ductus arteriosus - paracetamol - ibuprofen - echocardiography