A multicenter randomized controlled study on the efficacy and safety of paracetamol on symptomatic patent ductus arteriosus in premature infants

CHEN Jun; TIAN Luan-ying; WU Ben-qing; ZHONG Gui-chao; WANG Zhang-xing; QIU Hui-xian

doi:10.13820/j.cnki.gdyx.20184187

Abstract：Objective To observe the efficacy and safety of paracetamol on symptomatic patent ductus arteriosus (sPDA) in premature infants. Methods Premature infants who met the enrollment criteria were randomized to two groups, Paracetamol group (oral paracetamol 15 mg/kg every 6 hours for 3 days) and Ibuprofen group (oral ibuprofen 10 mg/kg every 24 hours for 3 days). If the ductus arteriosus was not closed, the second course of treatment was started immediately. The main outcome was rate of ductal closure, and the secondary outcomes were adverse effects and complications. Results A total of 4 hospitals in Shenzhen participated in this study. From January 2016 to March 2018, 127 premature infants, who were diagnosed of sPDA, were randomly assigned to receive either oral paracetamol (n=62) or oral ibuprofen (n=65). There was no difference between the 2 groups in the rate of ductal closure after the first or second course of treatment (P＞0.05), nor in the reopening rate (P＞0.05). The incidence of upper gastrointestinal bleeding in the paracetamol group (3.23％) was significantly lower than that in the ibuprofen group (15.38％) (P＜0.05). There was no significant difference in the incidence of feeding intolerance, necrotizing enterocolitis, renal failure, periventricular-intraventricular hemorrhages, bronchopulmonary dysplasia or the mortality between the two groups (P＞0.05). There was no significant difference in the urine volume, time of reaching total enteral nutrition, and hospitalization stay between the two groups (P＞0.05). Conclusion The efficacy and safety of paracetamol on premature infants with sPDA are similar to those of ibuprofen, and the incidence of upper gastrointestinal bleeding is superior to that of ibuprofen.