title: The efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia.
abstract: OBJECTIVE
  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).
  
  
  CONCLUSIONS
  Montelukast was not effective in reducing moderate or severe BPD. There were no significant adverse drug events associated with Montelukast treatment.
authors.affiliation: Department of Pediatrics, Ajou University School of Medicine, Suwon, Korea.
authors.forename: Sang Bum
authors.initials: SB
authors.lastname: Kim
authors.affiliation: Department of Pediatrics, Ajou University School of Medicine, Suwon, Korea.
authors.forename: Jang Hoon
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Department of Pediatrics, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Juyoung
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Pediatrics, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Seung Han
authors.initials: SH
authors.lastname: Shin
authors.affiliation: Department of Pediatrics, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Ho Sun
authors.initials: HS
authors.lastname: Eun
authors.affiliation: Department of Pediatrics, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Soon Min
authors.initials: SM
authors.lastname: Lee
authors.affiliation: Department of Pediatrics, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Jin A
authors.initials: JA
authors.lastname: Sohn
authors.affiliation: Department of Pediatrics, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Han Suk
authors.initials: HS
authors.lastname: Kim
authors.affiliation: Department of Pediatrics, Korea University Ansan Hospital, Ansan, Korea.
authors.forename: Byung Min
authors.initials: BM
authors.lastname: Choi
authors.affiliation: Department of Pediatrics, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Min Soo
authors.initials: MS
authors.lastname: Park
authors.affiliation: Department of Pediatrics, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Kook In
authors.initials: KI
authors.lastname: Park
authors.affiliation: Department of Pediatrics, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Ran
authors.initials: R
authors.lastname: Namgung
authors.affiliation: Department of Pediatrics, Ajou University School of Medicine, Suwon, Korea.
authors.forename: Moon Sung
authors.initials: MS
authors.lastname: Park
keywords: Broncopulmonary dysplasia; Leukotriene antagonists; Montelukast; Pharmacokinetics; Premature infant