Abstract
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.
Keywords
Premature PDA High-Dose Ibuprofen
