Acetaminophen vs. Ibuprofen in Early Treatment of Patent Ductus Arteriosus in Preterm Infants: A Non-Inferiority Randomized Clinical Trial
Solomiia Potsiurko, MD1*, Dmytro Dobryanskyy, PhD, MD1 and Lesya Sekretar, PhD, MD1
1Department of Pediatrics No. 2, Danylo Halytsky Lviv National Medical University, 69 Pekarska St., Lviv, 79010, Ukraine
*Corresponding Author: Dr. Solomiia Potsiurko, MD, Department of Pediatrics No. 2, Danylo Halytsky Lviv National Medical University, 69 Pekarska St., Lviv, 79010, Ukraine.
Received: March 29, 2022 Published: April 08, 2022
Abstract
Introduction: Patent ductus arteriosus (PDA) is one of the most common cardiovascular problems that occur in preterm infants. This trial aimed to investigate whether acetaminophen is non-inferior to ibuprofen in closing PDA in very pre-term infants.
Patients and Methods: A randomized non-inferiority trial was conducted on preterm infants with a gestational age <32 weeks, birth weight <1500 g, postnatal age <72 h, and PDA size >1.5 mm. Infants were randomly assigned to receive either intravenous acetaminophen (n=52) or rectal ibuprofen (n=52). The primary study outcome was the ductus closure within 24 hours after completion of the first and/or second course of pharmacological treatment.
Results: The incidence of PDA closure after completion of the first and/or second course of pharmacological treatment was identical 81% (42/52). After the first course of treatment, PDA closed in 37 infants (71%) in the ibuprofen group and 41 patients (79%) in the acetaminophen group (p>0.05). The median age (IQR) at the time of ductus closure was also the same in both groups, 5 (5-6) days. There were no statistically significant differences between the groups in the incidence of severe complications associated with preterm birth and mortality (p>0.05). No side effects related to pharmacological treatment were detected.
Conclusions: Acetaminophen is non-inferior to ibuprofen for the closure of PDA in very preterm infants.
Keywords: patent ductus arteriosus; PDA; acetaminophen; ibuprofen; very preterm infants.
Citation: Potsiurko S, Dobryanskyy D, Sekretar L. “Acetaminophen vs. Ibuprofen in Early Treatment of Patent Ductus Arteriosus in Preterm Infants: A Non-Inferiority Randomized Clinical Trial ”. SVOA Paediatrics 1:2 (2022) Pages 38-45.