High-dose Ibuprofen for Patent Ductus Arteriosus (PDA) in Preterm Infant

Summary

The investigators hypothesized that the early treatment of PDA with ibuprofen doses higher than those actually recommended might increase the closure rate in preterm infants with gestational age \<29 weeks without increasing the occurrence of associated adverse effects. To assess this hypothesis the investigators planned a multicenter randomized controlled study to compare the effectiveness of the current ibuprofen regimen to that of a high-dose regimen in closing PDA.

Timeline

Start

2008-06

Primary completion

2010-05

Completion

2010-10

Publications

• Dani C, Vangi V, Bertini G, Pratesi S, Lori I, Favelli F, Ciuti R, Bandinelli A, Martano C, Murru P, Messner H, Schena F, Mosca F. High-dose ibuprofen for patent ductus arteriosus in extremely preterm infants: a randomized controlled study. Clin Pharmacol Ther. 2012 Apr;91(4):590-6. doi: 10.1038/clpt.2011.284. Epub 2011 Nov 16.

Drugs

Indications