Evaluating the Effect of Prophylactic Acetaminophen in the Prevention of Patent Ductus Arteriosus (PDA) in Premature Neonates: A randomized clinical trial

Background: Patent Ductus Arteriosus (PDA) can cause serious clinical consequences in premature neonates. The purpose of this study is to determine the efficacy of prophylactic parenteral acetaminophen as a safer alternative drug for PDA in preterm infants. Methods: In a randomized clinical trial carried out in a one-year period, 60 preterm newborns under 30 weeks of gestational age with birth weights under 1500 grams, admitted in neonatal intensive care unit (NICU) of Emam Reza Hospital, Mashhad were studied. The prophylaxis group received parenteral acetaminophen for 3 days. Echocardiography was performed 96 hours after the last given dose and on the 14th day in both groups. Result: There were 30 newborns in each group. In the 4th-day echocardiography, in 33.3% of the prophylaxis group and 26.7% of the control group, the ductus arteriosus was closed (P=0.106). In the 14th-day echocardiography, the ductus was closed in 63% and 41.4% of the intervention and control group, respectively, which was not statistically significant. In addition there was not a significant difference in the ratio of left atrium to aortic root between the two groups. Conclusion: This study showed that in total, PDA was closed in more cases in the intervention group compared to the control group but the difference was not statistically significant. Acetaminophen is a new medicine for PDA closure, which may be more prevalent in future due to its cost effectiveness and safety.