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.