Closure of patent ductus arteriosus with oral acetaminophen in preterm neonates: A randomized trial

Abstract

Introduction: Patent ductus arteriosus (PDA) is one of the most common cardiac problems in preterm neonates which could lead to morbidities, such as chronic lung disease, intraventricular hemorrhage and retinopathy. The aim of this study was to evaluate the effect of oral acetaminophen on closure of PDA in preterm neonates. Methods: Sixty-nine neonates with significant PDA (confirmed through echocardiography) were recruited in this study. Ibuprofen and indomethacin were contraindicated in these neonates These newborns were randomly divided into two groups of cases (n=36) and controls (n=33). The case group was treated with oral acetaminophen at a dose of 15 mg/kg/dose every 6 hours for 72 hours. The control group did not receive any intervention. After 72 hours, both groups were re-evaluated by echocardiography. In case of failed closure of PDA, the second course of treatment would be administration of acetaminophen. The main outcome of this study was to evaluate the rate of closure of PDA and the side effects of the acetaminophen. Results: The overall rate of PDA closure in the acetaminophen-receiving group was 94.4%; the ductus arteriosus was closed in 75% of patients with the first course of treatment. Moreover, 19.4% of patients did not respond to the first course of the treatment but their ductus arteriosus was closed with the second course of acetaminophen treatment. Of the patients, 5.6% did not respond to both courses of acetaminophen treatments. For the control group, the closure rate of PDA was 15.1%. Conclusion: The results of the study showed that oral acetaminophen is an effective alternative treatment for PDA in preterm neonates.