Acetaminophen versus Ibuprofen for the management of hemodynamically significant patent ductus arteriosus in very low birth weight infants: randomized trial.

OBJECTIVE

The objective was to evaluate the efficacy and safety of Acetaminophen versus Ibuprofen in the treatment of hemodynamically significant patent ductus arteriosus.

METHOD: A randomized, partially blinded controlled study was conducted in very low birth weight infants. Diagnostic criteria included a ductal diameter of 1.5 millimeters or greater, left cavities dilation or a left atrium to aortic root ratio greater than 1.4, and retrograde flow. Preterm infants were randomized into intravenous Acetaminophen or Ibuprofen treatment groups. Ductal closure was evaluated at the end of the third treatment day. A blood count and renal and liver function tests were done before and after treatment.

RESULTS

120 preterm infants were enrolled; 60 were randomized to each treatment group. The average pre-treatment ductal diameter was similar between both groups. Mean weight and gestational age were 1145 grams and 28.3 weeks for Acetaminophen, and 1096 grams and 27.6 weeks for Ibuprofen. The ductal closure rate after the first treatment course was 66.7% in the Acetaminophen group and 63.3% in the Ibuprofen group (p = 0.70), increasing to 88.3% and 86.7%, respectively, after the second course (p = 0.78). In the Acetaminophen group, the need for surgical closure was 10% and in the Ibuprofen group 11.7% (p = 0.77). No significant differences were observed in laboratory tests before and after treatment.

CONCLUSION

Acetaminophen may be considered a safe and effective alternative, with no differences in side effects, to ibuprofen for treating hemodynamically significant patent ductus arteriosus in very low birth weight premature infants.