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

Ori Hochwald; Gur Mainzer; Liron Borenstein-Levin; Huda Jubran; Gil Dinur; Meirav Zucker; Malka Mor; Asaad Khoury; Amir Kugelman

doi:10.1055/s-0038-1653946

American Journal of Perinatology, Table of Contents

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

Ori Hochwald

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

,

Gur Mainzer

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

³Department of Pediatric Cardiology, Baruch Padeh Medical Center, Poriya, Israel

,

Liron Borenstein-Levin

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

,

Huda Jubran

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

,

Gil Dinur

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

,

Meirav Zucker

²Department 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

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

,

Asaad Khoury

²Department 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

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

› Author Affiliations

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 31^6/7 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

Full Text

References

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