Abstract

Dr. Morteza Habibi, Dr. Mohammad Nobakht, Dr. Tahereh Jangjoo Pirbazari* and Dr. Zohreh Yazdi

ABSTRACT

Background: Patent ductus arteriosus (PDA) is one of the more common congenital heart defects in preterm neonates. The closure of PDA can be done with ibuprofen; however, this drug is associated with many contraindications and potential side-effects. In the past three years, oral acetaminophen has been proposed for the treatment of PDA. This study was designed to evaluate the efficacy and safety of oral acetaminophen and oral ibuprofen for the pharmacological closure of PDA in preterm infants. Methods: In this randomized, double-blinded, parallel-controlled trial, 77 preterm infants (gestational age ? 37 weeks) with echocardiographically confirmed PDA was randomly assigned to receive either oral acetaminophen (n= 40; 15 mg/kg every 6 hours for 2 days) or ibuprofen (n= 37; initial dose of 10 mg/kg, followed by 5 mg/kg at 12 and 24 hours). After the initial treatment course in both groups, the need for a second course was determined by echocardiographic evaluation. The main outcome was rate of ductal closure, and secondary outcomes were adverse effects and complications. Results:After the initial treatment, the overall incidence of medical PDA closure with ibuprofen was 75.7%(n= 28) as compared with 87.5% (n= 35) in the acetaminophen group (p= 0.179). After the second course of treatment, ductal closure occurred in all 5 infants treated with acetaminophen, and 5 of 9 infants (55.6%) treated with ibuprofen (p= 0.211). No significant differences in clinical side effects or complications were note (p= 0.611). Conclusion: Oral acetaminophen was comparable to ibuprofen in terms of the rate of ductal closure. There were no differences between the two drugs with respect to safety. Therefore, oral acetaminophen could be used as an alternative agent for the treatment of PDA in preterm infants.