Role of Montelukast in Modulation of Response to Sepsis in Preterm Infants

Summary

The investigators will conduct this study to explore the role of Montelukast in treatment of neonatal sepsis and whether it has an effect on inflammatory markers, the duration of antibiotic use, or on the patients´ outcome.

Timeline

Start

2020-07-24

Primary completion

2021-02-10

Completion

2021-02-10

Outcome

Missed primary endpoint

paper The incidence of moderate to severe BPD was not different between the groups PMID 26512261 ↗

paper Montelukast was not effective in reducing moderate or severe BPD. PMID 26512261 ↗

Publications

• Background van Adelsberg J, Moy J, Wei LX, Tozzi CA, Knorr B, Reiss TF. Safety, tolerability, and exploratory efficacy of montelukast in 6- to 24-month-old patients with asthma. Curr Med Res Opin. 2005 Jun;21(6):971-9. doi: 10.1185/030079905X48456.
• Results 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. The efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia. Korean J Pediatr. 2015 Sep;58(9):347-53. doi: 10.3345/kjp.2015.58.9.347. Epub 2015 Sep 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Montelukast	Other / unclassified	1.5 mg	Other
Subject	Montelukast	Other / unclassified	2 mg	Other

Indications