Role of Montelukast in Modulation of Response to Sepsis in Preterm Infants
Condition: Neonatal Sepsis
MeSH terms: Sepsis; Toxemia; Neonatal Sepsis
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      Since inflammatory mediators play a crucial role in the pathophysiology of sepsis so
      anti-inflammatory treatment, Montelukast, could be a beneficial therapy. The investigators
      will conduct this pilot, open-labeled, randomized controlled intervention trial on 40
      newborns admitted to NICU. The study will include late preterm infants with gestational age
      (34 weeks to less than 37 weeks) with clinical evidence of sepsis. The study included an
      intervention group (n=20) that will receive oral Montelukast for 10 days with antibiotics in
      addition to the conventional antibiotic therapy regimen according to NICU policy while the
      control group (n=20) will receive antibiotics in addition to the conventional antibiotic
      therapy regimen according to NICU policy. After obtaining a fully informed written consent
      from the neonate's parents or guardians, patients will be recruited and group allocated in
      the study by random pick up of closed opaque sealed envelopes. Patients will be observed
      clinically and by laboratory investigations along the duration of hospital admission through
      a structured collection sheet. Demographic data, cause of admission, clinical data (vital
      signs, activity, feeding intolerance, respiratory symptoms, duration of oxygen support, use
      of inotropes) will be recorded. Blood sampling will be performed twice in both groups, on
      admission, and 10 days after treatment. The following investigations will be carried out:
      complete blood picture, C-reactive protein (CRP), tumor necrosis factor-alpha (TNF alpha),
      blood culture, Serum creatinine, Liver enzymes, and INR. A lumbar puncture will be performed
      when the treating physicians suspect meningitis. Patients in both groups will be observed
      along the duration of hospital admission to detect the outcome.

      Patients in the intervention group, receiving Montelukast sodium (Singulair), will be given
      at a dose according to body weight (1.5 kg to 2 kg, will be given 1.5 mg; greater than 2 kg,
      will be given 2 mg). This dose was previously prescribed and given to preterm neonates
      suffered from bronchopulmonary dysplasia by Kim et al. (2015). Four mg of the drug will be
      dissolved in four ml milk and 1.5 - 2 ml milk only will be given once daily at 9 pm via an
      orogastric tube or by oral administration for 10 days. Along the period of NICU admission,
      patients receiving Montelukast will be closely observed for the development of any of its
      side effects that including "diarrhea, colic, vomiting, fever or cough" (Adelsberg et al.,
      2005).
    

Intervention name(s): Montelukast Sodium
Intervention type(s): Drug
Intervention description(s): Montelukast sodium (Singulair) will be given at a dose according to body weight. Four mg of the drug will be dissolved in four ml milk and the dose will be given once daily at 9 pm for 10 days.
Other intervention name(s): Singulair
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sepsis; Montelukast; TNF alpha; premature infant