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A Comparison of Ibuprofen and Indomethacin for Closure of Patent Ductus Arteriosus - Comparison of Ibuprofen and Indomethacin for Closure of Patent Ductus Arteriosus
Description:
A Comparison of Ibuprofen and Indomethacin for Closure of Patent Ductus Arteriosus.
Hypothesis:
In animals, parenteral ibuprofen has been shown t have equivalent efficacy to indomethacin for closure of patent ductus arteriosus (PDA) without compromise of cerebral, gastrointestinal, or renal perfusion. The investigators asked: What is the efficacy and safety of ibuprofen compared to indomethacin for PDA closure in premature infants with respiratory distress syndrome (RDS)?
Study Design
Study Design:
Patients Enrolled: 148
Drug/Procedures Used:
Non-blinded, randomized, multicenter trial of ibuprofen vs. indomethacin for PDA closure in 148 premature infants (24 to 32 weeks gestational age) with RDS (and no major congenital abnormalities) in five neonatal ICUs. Ductal patency was assessed using echocardiography by readers blinded to treatment assignment. Indomethacin was given as rescue therapy to infants who failed the first randomized treatment.
Principal Findings:
The rate of PDA closure was similar in both groups (66% with indomethacin vs. 70% with ibuprofen, p = NS). Survival at one month was not different between the treatment groups. Oliguria occurring during treatment was more frequent (18.9% vs. 6.8%, p = 0.03) and increase in serum creatinine greater in the indomethacin-treated infants. The development of necrotizing enterocolitis and intraventricular hemorrhage were not different between treatment groups, but the numbers of these complications were small.
Parental ibuprofen has similar efficacy to indomethacin for closure of PDA in premature infants with a lower risk of developing renal dysfunction during treatment. Long-term effects of ibuprofen on the gastrointestinal and central nervous systems are unknown.
Interpretation:
70% of infants born at <28 weeks gestational age have PDA that require closure. Therefore, this pilot study demonstrates potential benefit for a large number of infants. Unfortunately, as pointed out in the accompanying editorial, parenteral ibuprofen is currently not available in the United States for clinical trials or treatment.
References:
1. Van Overmeire B, Smets K, Lecoutere DN, et al. Engl J Med 2000;343:674-81.
Keywords: Infant, Newborn, Enterocolitis, Necrotizing, Ibuprofen, Creatinine, Infant, Premature, Oliguria, Indomethacin, United States, Ductus Arteriosus, Patent, Echocardiography
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