Clinical and Experimental Pediatrics

The Korean Pediatric Society (대한소아청소년과학회)
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The efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia

  • Kim, Sang Bum (Department of Pediatrics, Ajou University School of Medicine) ;
  • Lee, Jang Hoon (Department of Pediatrics, Ajou University School of Medicine) ;
  • Lee, Juyoung (Department of Pediatrics, Seoul National University College of Medicine) ;
  • Shin, Seung Han (Department of Pediatrics, Seoul National University College of Medicine) ;
  • Eun, Ho Sun (Department of Pediatrics, Yonsei University College of Medicine) ;
  • Lee, Soon Min (Department of Pediatrics, Yonsei University College of Medicine) ;
  • Sohn, Jin A (Department of Pediatrics, Seoul National University College of Medicine) ;
  • Kim, Han Suk (Department of Pediatrics, Seoul National University College of Medicine) ;
  • Choi, Byung Min (Department of Pediatrics, Korea University Ansan Hospital) ;
  • Park, Min Soo (Department of Pediatrics, Yonsei University College of Medicine) ;
  • Park, Kook In (Department of Pediatrics, Yonsei University College of Medicine) ;
  • Namgung, Ran (Department of Pediatrics, Yonsei University College of Medicine) ;
  • Park, Moon Sung (Department of Pediatrics, Ajou University School of Medicine)
  • Received : 2014.08.27
  • Accepted : 2014.11.04
  • Published : 2015.09.10
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Abstract

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

References

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