Korean J Pediatr.  2015 Sep;58(9):347-353. 10.3345/kjp.2015.58.9.347.

The efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia

• Kim SB
• Lee JH
• Lee J
• Shin SH
• Eun HS
• Lee SM
• Sohn JA
• Kim HS
• Choi BM
• Park MS
• Park KI
• Namgung R
• Park MS

• KMID: 2284516
• DOI: http://doi.org/10.3345/kjp.2015.58.9.347

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.

Keyword

Broncopulmonary dysplasia; Leukotriene antagonists; Montelukast; Pharmacokinetics; Premature infant

MeSH Terms

Body Weight
Bronchopulmonary Dysplasia*
Drug-Related Side Effects and Adverse Reactions
Gestational Age
Health Resorts
Humans
Incidence
Infant
Infant, Newborn
Infant, Premature
Leukotriene Antagonists
Pharmacokinetics
Prospective Studies
Sodium*
Steroids
Ventilation
Leukotriene Antagonists
Sodium
Steroids