The Effect of Oral High-dose Ibuprofen on Patent Ductus Arteriosus Closure in Preterm Infants.

OBJECTIVE: The aim of this study is to compare the efficacy and possible adverse effects of the oral high-dose ibuprofen regimen to that of standard regimen in closing patent ductus arteriosus (PDA).

STUDY DESIGN: This clinical trial study was performed from April 2012 to May 2013 on preterm infants with gestational age<37 weeks and postnatal age 3 to 7 days with echocardiographic diagnosis of hemodynamically significant PDA. These neonates were randomly assigned to two treatment groups that respectively received high dose (20-10-10 mg/kg/d) and standard dose (10-5-5 mg/kg/d) oral ibuprofen regimen for 3 days. Effect of ibuprofen therapy was evaluated by echocardiography and neonates were followed for renal dysfunction, gastrointestinal complication, bleeding, and hyperbilirubinemia.

RESULTS: From a total of 60 enrolled infants, 30 cases received the high dose of ibuprofen and the remaining 30 received the standard dose. Complete ductal closure was observed in 20 (70%) infants treated with high-dose regimen in comparison with 11 (36.7%) in the standard-dose regimen group (p=0.010). No gastrointestinal, renal, or hematological adverse effects were reported.

CONCLUSION: The high-dose oral ibuprofen seems to be more effective than the current standard dose regimen for PDA closure in premature neonates without increasing the adverse effects.