A randomized, double-blind, placebo- controlled trial on intravenous ibuprofen L-lysine for the early closure of nonsymptomatic patent ductus arteriosus within 72 hours of birth in extremely low-birth-weight infants

Jacob V. Aranda, Ronald Clyman, Blair Cox, Bart Van Overmeire, Paul Wozniak, Ilene Sosenko, Waldemar A. Carlo, Robert M. Ward, Robert Shalwitz, Geraldine Baggs, Anand Seth, Laszlo Darko

Research output: Contribution to journalArticle

64 Scopus citations

Abstract

A multicenter, double-blind, randomized, placebo-controlled trial was conducted to evaluate the efficacy and safety of intravenous (IV) ibuprofen (L-lysine) for the early closure of nonsymptomatic patent ductus arteriosus (PDA) within 72 hours of birth in extremely low-birth-weight (ELBW) infants with evidence of ductal shunting by echo- cardiogram. Eleven sites enrolled 136 infants with nonsymptomatic early PDA (gestational age < 30 weeks; body weight 500 to 1000 g) to receive a 3-day course (10 mg/kg, 5 mg/kg, and 5 mg/kg) of IV ibuprofen (n = 68) or placebo (n = 68). Cardiac echocardiogram was performed on study days 1 and 14, and with rescue. Infants were followed to 36 weeks postconceptional age. Patient demographics, mean (standard deviation), were similar between ibuprofen and placebo: birth weight: 798.5 g (128.7) versus 797.3 g (132.8); gestational age: 26.1 weeks (1.3) versus 26.2 weeks (1.4); and age at first dose: 1.5 days (0.7). The intent-to-treat analysis of the primary endpoint, subjects rescued, died, or dropped through study day 14, was 21/68 (30.9%) with ibuprofen and 36/68 (52.9%) for placebo (p = 0.005). Death, intraventricular hemorrhage, necrotizing enterocolitis, daily fluid intake/output, liver function, bronchopulmonary dysplasia, and retinopathy of prematurity did not differ. A trend toward decreased periventricular leukomalacia by ibuprofen was noted. IV ibuprofen was effective and safe in the early closure of PDA in preterm neonates.

Original languageEnglish (US)
Pages (from-to)235-246
Number of pages12
JournalAmerican Journal of Perinatology
Volume26
Issue number3
DOIs
StatePublished - Mar 1 2009

Keywords

  • Cyclooxygenase inhibitors
  • Ibuprofen
  • Patent ductus arteriosus
  • Premature newborn
  • Randomized clinical trial

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Obstetrics and Gynecology

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