This study was aimed at evaluating the efficacy of ibuprofen in the prophyl
axis of patent ductus arteriosus (PDA) in very preterm neonates and at dete
cting eventual side-effects. A total of 46 preterm neonates with gestationa
l age under 31 weeks were randomly assigned at 2 h of life: 23 to the proph
ylaxis group and 23 to the control group. The prophylaxis group received in
travenous treatment with ibuprofen lysine (10 mg/kg), followed by 5 mg/kg a
fter 24 h and 48 h. No placebo was given to the control group. No PDA was d
emonstrated at 72 h of life in 20 of the 23 babies in the ibuprofen group (
87%) nor in 7 of the 23 control neonates (30.4%). All neonates with PDA rec
eived treatment with indomethacin. One neonate in the prophylaxis group and
three in the control group underwent surgical ligation. Prophylaxis with i
buprofen was not associated with any significant side-effect except for foo
d intolerance.
Conclusion Ibuprofen prophylaxis seems to be efficient in closing patent du
ctus arteriosus and in reducing indomethacin treatment. No significant earl
y side-effects were found due to ibuprofen.