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Korean J Pediatr 2015 September;58(9) :347-353.
Published online 2015 September 15.       
The efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia
Sang Bum Kim1, Jang Hoon Lee1, Juyoung Lee2, Seung Han Shin2, Ho Sun Eun3, Soon Min Lee3, Jin A Sohn2, Han Suk Kim2, Byung Min Choi4, Min Soo Park3, Kook In Park3, Ran Namgung3, Moon Sung Park1
1Department of Pediatrics, Ajou University School of Medicine, Suwon, Korea
2Department of Pediatrics, Seoul National University College of Medicine, Seoul, Korea
3Department of Pediatrics, Yonsei University College of Medicine, Seoul, Korea
4Department of Pediatrics, Korea University Ansan Hospital, Ansan, Korea
Corresponding Author: Moon Sung Park ,Tel: +82-31-219-5165, Fax: +82-31-219-5169, Email:
Copyright © 2015 by The Korean Pediatric Society
Purpose: The purpose of this study was to evaluate the efficacy and safety of Montelukast sodium in the prevention of bronchopulmonarydysplasia (BPD).
Methods: The Interventional study was designed as a multicenter, prospective, and randomized trial, with open labeled and parallel-experimental groups, 66 infants were enrolled and allocated to either the case group (n=30) or the control group (n=36) based on gestational age (GA). Infants in the case group were given Montelukast sodium (Singulair) based on their body weight (BW). Zero week was defined as the start time of the study.
Results: The incidence of moderate to severe BPD was not different between the groups (case group: 13 of 30 [43.3%] vs. control group: 19 of 36 [52.8%], P=0.912). Additionally, secondary outcomes such as ventilation index, mean airway pressure and resort to systemic steroids were not significantly different. There were no serious adverse drug reactions in either group, and furthermore the rate of occurrence of mild drug related-events were not significantly different (case group: 10 of 42 [23.8%] vs. control group: 6 of 48 (15.8%), P=0.414).
Conclusion: Montelukast was not effective in reducing moderate or severe BPD. There were no significant adverse drug events associated with Montelukast treatment.
Keywords: Broncopulmonary dysplasia | Leukotriene antagonists | Montelukast | Pharmacokinetics | Premature infant
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Supplementary Material  Supplementary Material
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Montelukast as an add-on therapy in bronchopulmonary dysplasia  2009 February;52(2)
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Risk Factors and Outcome of Bronchopulmonary Dysplasia  1994 January;37(1)
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