The Effects of Acetaminophen Prophylaxis on Patent Ductus Arteriosus Closure in Premature Infants: A Clinical Trial Study

Background There is little evidence of the efficacy of acetaminophen prophylaxis in preventing PDA in premature infants. Regarding the effects of acetaminophen in these cases and also safety of this drug in preterm infants, as well as the high prevalence of arterial duct in our population, we aimed to determine the preventive effects of this drug on PDA in preterm infants. Materials and Methods In this clinical trial, 64 premature infants with gestational age less than 31 weeks were randomly divided into two groups including intervention group receiving acetaminophen prophylaxis (10 mg/kg) every 6 hours for 5 days and the control group did not receive any intervention. After 10 days, both groups were assessed by echocardiography regarding the PDA condition. Serum levels of ALT and AST enzymes were also measured 10 days later and simultaneously with doing echoes. Results There was a significant different in the rate of PDA closure across the two intervention and control groups (84.4% versus 50.0%, p = 0.007). After the intervention, open PDA was found in 50% of neonates in control group and 15.6% in intervention group that were treated with ibuprofen and echocardiography was performed again after 1 month. PDA was closed in the remaining 87.5% in the control group and remaining 100% of patients in the intervention group indicating no difference (p = 0.632). The changes in liver enzymes slightly changed after intervention. Conclusion Preventive treatment with acetaminophen can effectively lead to PDA closure in premature infants.