The efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia.
10.3345/kjp.2015.58.9.347
- Author:
Sang Bum KIM
1
;
Jang Hoon LEE
;
Juyoung LEE
;
Seung Han SHIN
;
Ho Sun EUN
;
Soon Min LEE
;
Jin A SOHN
;
Han Suk KIM
;
Byung Min CHOI
;
Min Soo PARK
;
Kook In PARK
;
Ran NAMGUNG
;
Moon Sung PARK
Author Information
1. Department of Pediatrics, Ajou University School of Medicine, Suwon, Korea. drparkms@ajou.ac.kr
- Publication Type:Randomized Controlled Trial ; Multicenter Study ; Original Article
- Keywords:
Broncopulmonary dysplasia;
Leukotriene antagonists;
Montelukast;
Pharmacokinetics;
Premature infant
- MeSH:
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
- From:Korean Journal of Pediatrics
2015;58(9):347-353
- CountryRepublic of Korea
- Language:English
-
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.
