Montelukast as an add-on therapy in bronchopulmonary dysplasia

Kim, He Min; Song, Ji Eun; Lee, Soon Min; Park, Min Soo; Park, Kook In; Namgung, Ran; Lee, Chul

doi:10.3345/kjp.2009.52.2.181

Cited by 5 publications

(15 citation statements)

References 22 publications

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“…The recruited infants received different doses of Montelukast. Kim and coworkers [12] gave Montelukast according to body weight (< 1 kg body weight: 0.5 mg, 1-1.5 kg: 1 mg, 1.5-2 kg: 1.5 mg and more than 2kg: 2 mg) while in Rupprecht et al, [11] the dose was once daily 1 mg/kg in the rst week of therapy then 1.5 mg/kg in the second week and increased to 2 mg/kg in the third) whereas In 2009, Kim and coauthors [29] prescribed Montelukast (Once daily 1 mg/kg). All reported that Montelukast is safe to be used in neonates with no documented signi cant side effects.…”

Section: Discussionmentioning

confidence: 98%

Role of Montelukast in Modulation of Response to Sepsis in Preterm Infants: A Randomized-controlled Trial

El-Shehaby

Elshahawy

Nasef

et al. 2021

Preprint

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Inflammatory mediators play a crucial role in the pathophysiology of neonatal sepsis. Montelukast, as an anti-inflammatory drug, could be a beneficial therapy. This study aimed to explore the adjuvant role of Montelukast in regulating the inflammatory response associated with neonatal sepsis and its associated effect on the clinical outcomes. An open-label, randomized controlled intervention trial conducted on 40 late preterm newborn (gestational age 340/7 to 366/7 weeks) admitted to NICU, with clinical evidence of sepsis. In the Montelukast group (n=20), infants received oral Montelukast once daily for 10 days (infant's weight <2 kg received 1.5 mg whereas >2 kg received 2 mg) with antibiotics plus routine supportive care. In the routine care group (n=20), infants received antibiotics plus routine supportive care. Primary outcome was the serum level of tumor necrosis factor (TNF) alpha at day 10 of therapy. Secondary outcomes included the clinical outcomes along hospital admission. Baseline characteristics were non-significantly different between both groups. After 10 days of therapy, TNF alpha level was significantly lower in the Montelukast group (80.73+50.25 versus 119.54+58.46; p= 0.03). There were non-significant differences between both groups regarding duration of NICU admission, antibiotics duration or modalities and duration of respiratory support. C-reactive protein didn’t differ between both groups (p= 0.256). No documented significant adverse effects of Montelukast during the study period. Conclusion: in late preterm neonates with sepsis, 10 days of Montelukast therapy as an adjuvant to antibiotics lowered TNF alpha level without any impact on clinical outcomes.

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Section: Discussionmentioning

confidence: 98%

Role of Montelukast in Modulation of Response to Sepsis in Preterm Infants: A Randomized-controlled Trial

El-Shehaby

Elshahawy

Nasef

et al. 2021

Preprint

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“…Vitamin A, caffeine, postnatal corticosteroids, and stem cells from cord blood may help repair the preterm lung. Kim et al 19) , reported Montelukast as an adjunct therapy, in BPD. Montelukast (1 mg/kg/day) was administered to 15 preterm infants with established BPD for an average period of 12 weeks.…”

Section: Discussionmentioning

confidence: 99%

“…The effect of Montelukast on BPD in neonatal intensive care setting have been published 19) , but it had small population and retrospective design. Therefore we performed this study in order to determine the efficacy and safety of Montelukast on BPD in preterm infants, with prospective, randomized trial.…”

Section: Introductionmentioning

confidence: 99%

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

Kim

Lee

et al. 2015

Korean J Pediatr

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PurposeThe purpose of this study was to evaluate the efficacy and safety of Montelukast sodium in the prevention of bronchopulmonarydysplasia (BPD).MethodsThe 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.ResultsThe 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).ConclusionMontelukast was not effective in reducing moderate or severe BPD. There were no significant adverse drug events associated with Montelukast treatment.

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“…The five clinical studies included one randomized trial from Korea [46], a non-randomized study performed in Germany and the USA [47], and tree observational studies from Korea [48], the UK [49] and Taiwan [50]. Four studied treatment and one studied prevention of BPD [46].…”

Section: Clinical Studiesmentioning

confidence: 99%

“…Outcomes for the randomized trial [46] and the four non-randomized [47][48][49][50] clinical studies are reported in Table 7.…”

Section: Clinical Studiesmentioning

confidence: 99%

Antileukotrienes for the prevention and treatment of chronic lung disease in very preterm newborns: a systematic review

et al. 2021

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Background Very preterm infants are at high risk of developing chronic lung disease, which requires respiratory support and might have long-term sequelae. As lung inflammation plays an important role in pathogenesis, antileukotrienes have been explored in both clinical and animal studies. We aimed to assess the benefits and harms of antileukotrienes for the prevention and treatment of respiratory morbidity and mortality in very preterm newborns. Methods In this systematic review, we included randomized trials and non-randomized studies in humans and animals reporting the effects of antileukotrienes in very preterm infants or other mammals within 10 days of birth. Our pre-specified primary outcomes were all-cause mortality and any harm, and, for the clinical studies, incidence of chronic lung disease. Included studies underwent risk of bias-assessment and data extraction performed by two authors independently. There were no language restrictions. Results Fifteen studies totally met our inclusion criteria: one randomized trial and four non-randomized studies in humans and 10 animal studies (five in rodents, two in lambs and one in either guinea pigs, rabbits or caprinae). All five clinical studies used montelukast and had a small sample size, ranging from 4 to 77 infants. The randomized trial (n = 60) found no difference in the incidence of chronic lung disease between the groups. Only one clinical study, which enrolled four very preterm infants and had a critical overall risk of bias, reported long-term outcomes. All other studies had unclear or greater overall risk of bias and meta-analyses were therefore deemed unfeasible. Eight of ten animal studies used leukotriene receptor antagonists as antileukotriene (montelukast in three of ten studies) and seven had an experimental study design (i.e. some animals were not exposed to antileukotrienes but no randomization). Three of the ten animal studies assessed different doses. Animal studies found no effect on the outcomes mortality, growth, or lung function related surrogate outcomes. Conclusions Use of antileukotrienes in very preterm infants to prevent or treat chronic lung disease is not supported by the available evidence. Large randomized trials focusing on outcomes relevant to patients, including long-term outcomes, are needed. Studies should also minimize risk of bias.

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Montelukast as an add-on therapy in bronchopulmonary dysplasia

Cited by 5 publications

References 22 publications

Role of Montelukast in Modulation of Response to Sepsis in Preterm Infants: A Randomized-controlled Trial

Role of Montelukast in Modulation of Response to Sepsis in Preterm Infants: A Randomized-controlled Trial

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

Antileukotrienes for the prevention and treatment of chronic lung disease in very preterm newborns: a systematic review

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