Pharmacokinetics, safety and preliminary efficacy study of montelukast in critically ill infants with developing bronchopulmonary dysplasia (PRISM)

Bronchopulmonary dysplasia (BPD) is an inflammatory disease stemming from premature birth and iatrogenic lung injury. BPD is relatively common and frequently fatal; despite this, there are no FDA-approved therapies. Montelukast is increasingly used to treat developing BPD despite scant safety and efficacy data. Infants with developing BPD have high levels of inflammatory leukotrienes; montelukast blocks the cysteinyl leukotriene receptor. Montelukast shows promise due to results from several small BPD studies. For this Pharmacokinetic and pharmacodynamic study of montelukast in infants with developing BPD (PRISM) trial, we chose the smallest dose and shortest treatment duration that maintained a prospect for direct benefit. PRISM is a randomized, double-blind, placebo-controlled trial (5 sites, n=28) of 0.75 mg/kg enteral montelukast dosed every 24 hours for up to 7 days. Eligible infants (