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

Abstract

\n 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.