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High-dose ibuprofen for patent ductus arteriosus in extremely preterm infants: a randomized controlled study.

Abstract
Our aim was to assess the hypothesis that a high-dose regimen of ibuprofen is more effective than the standard-dose regimen in closing patent ductus arteriosus (PDA) without increasing adverse effects. Infants of gestational age <29 weeks, with respiratory distress syndrome (RDS) and echocardiographic evidence of significant PDA at 12-24 h of life, were randomized to receive a standard (10-5-5 mg/kg/day) or high-dose (20-10-10 mg/kg/day) course of ibuprofen. We studied 70 infants, 35 of whom received the standard dose of ibuprofen and the other 35 the high dose. Of the infants treated with the standard-dose regimen, 37% had persistent PDA as compared with 14% of those treated with the high-dose regimen (P = 0.03). No differences in the occurrence of adverse effects were observed between the two groups. The high-dose ibuprofen regimen is more effective than the standard-dose regimen in closing PDA in preterm infants <29 weeks of gestation without increasing the adverse effect rate.
AuthorsC Dani, V Vangi, G Bertini, S Pratesi, I Lori, F Favelli, R Ciuti, A Bandinelli, C Martano, P Murru, H Messner, F Schena, F Mosca
JournalClinical pharmacology and therapeutics (Clin Pharmacol Ther) Vol. 91 Issue 4 Pg. 590-6 (Apr 2012) ISSN: 1532-6535 [Electronic] United States
PMID22089267 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Ibuprofen
Topics
  • Dose-Response Relationship, Drug
  • Ductus Arteriosus, Patent (drug therapy, epidemiology, physiopathology)
  • Female
  • Humans
  • Ibuprofen (administration & dosage)
  • Infant, Extremely Low Birth Weight (physiology)
  • Infant, Newborn
  • Male

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