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Published Online First: 3 September 2007. doi:10.1136/adc.2007.120584
Archives of Disease in Childhood - Fetal and Neonatal Edition 2008;93:F94-F99
Copyright © 2008 BMJ Publishing Group Ltd & Royal College of Paediatrics and Child Health.

ORIGINAL ARTICLES

Comparison of ibuprofen and indometacin for early-targeted treatment of patent ductus arteriosus in extremely premature infants: a randomised controlled trial

B-H Su, H-C Lin, H-Y Chiu, H-Y Hsieh, H-H Chen and Y-C Tsai

Department of Paediatrics, China Medical University Hospital, Taichung, Taiwan

Correspondence to:
Dr B-H Su, Department of Paediatrics, China Medical University Hospital, Taiwan, 2 Yuh Der Rd, Taichung 404, Taiwan; bais{at}ms49.hinet.net

Background: To date there is no firm conclusion as to the efficacy and safety of ibuprofen compared with indometacin for patent ductus arteriosus (PDA) closure in extremely premature infants.

Objective: To conduct a randomised controlled trial to better address this problem.

Methods: 119 infants (gestational age <=28 weeks) with respiratory distress syndrome and PDA confirmed by echocardiography were randomly assigned to receive either indometacin (0.2 mg/kg) or ibuprofen (10 mg/kg), starting at <24 hours of life, followed by half these first doses within 48 hours at 24-hour intervals if indicated by echocardiographic PDA flow pattern.

Results: The PDA closure rate and the doses of drug (mean (SD)) were similar in both groups: 53/60 (88.3%) and 1.9 (1.5) mg/kg in infants given ibuprofen, and 52/59 (88.1%) and 1.9 (1.7) mg/kg in infants given indometacin. No significant difference was found in the numbers of infants requiring surgical ligation, and the levels of post-treatment serum creatinine and urea nitrogen between the two groups. Although not significantly different, more infants (9/59 (15.3%)) treated with indometacin tended to develop oliguria (<1 ml/kg/h) than those treated with ibuprofen (4/60 (6.7%)). There were no significant differences in side effects or complications between the two groups.

Conclusions: Ibuprofen is as effective as indometacin for the early-targeted PDA treatment in extremely premature infants, without increasing the incidence of complications. When the echocardiographic PDA flow pattern was used as a guide for PDA treatment, fewer doses of drugs were needed to achieve acceptable closing rates.


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eLetters:

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Ibuprofen versus indomethacin in the treatment of persistent patent ductus arteriosus (PDA): What’s
Yoginder Singh
Fetal Neonatal Ed. Online, 30 Mar 2009 [Full text]
Ibuprofen versus indomethacin in the treatment of persistent patent ductus arteriosus (PDA)
Yoginder Singh
Fetal Neonatal Ed. Online, 30 Mar 2009 [Full text]

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