Evaluating the Effectiveness of Ibuprofen from 2 Different Brands in Patent Ductus Arteriosus Closure in Preterm Neonates

Abstract

Background: Patent ductus arteriosus (PDA) is a common condition in premature babies, with a prevalence rate of 30 - 60%, and often requires medical or surgical intervention. Objectives: This study aimed to assess the effectiveness of 2 different brands of ibuprofen in PDA closure in preterm infants weighing less than 1500 g. Methods: This single-blind clinical trial study was performed on 75 premature neonates with PDA in the pediatric ward of Vali-Asr Hospital in Birjand from March 2014 to March 2019. Patients were treated with two brands of ibuprofen at doses of 10 mg/kg for the first day and 5 mg/kg for the second and third days (24 and 48 hours afterward). Before and three days after the last dose, the children were examined by pediatric cardiologist echocardiography. The data were input into SPSS version 23 and analyzed using descriptive statistics, such as mean and SD. Inferential statistics, such as the chi-square test, were also employed with a significance level of P-value < 0.05. Results: There was a significant difference between the rate of PDA closure, 78.8% in the Pedea group vs. 54.8% in the Ibuprofen group (P = 0.03). In the Ibuprofen group, there was no difference in drug efficacy in PDA closure between male and female neonates (P = 0.663). Also, in the Pedea group, there was a significant difference in terms of efficacy between male and female neonates (P = 0.049). No significant difference was observed in PDA closure between the two medications based on their sizes (P = 0.616 in small size, P = 0.266 in medium size, and P = 0.175 in large size). Conclusions: Pedea is more effective than Ibuprofen. It reduces complications and the need for surgery. However, there was no significant relationship between the two drugs based on the PDA sizes. Therefore, it seems logical to use the Iranian brand of ibuprofen, considering the benefits equal to the foreign one.