Pharmacokinetics, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants with Developing Bronchopulmonary Dysplasia (PRISM)

The PRISM study is a clinical trial investigating the safety, dosing, and early effectiveness of montelukast?a medication commonly used for asthma and allergies?in premature infants at high risk of developing bronchopulmonary dysplasia (BPD), a serious lung condition. These infants are typically born before 28 weeks of pregnancy and weigh less than 1,000 grams. In this trial, 28 critically ill infants who need breathing support and oxygen will receive either montelukast or a placebo once daily for 7 days. The study?s main goals are to understand how the drug is processed by these infants' bodies (pharmacokinetics), assess side effects (especially any impact on brain development), and see if the drug can help reduce inflammation and the need for breathing support. Montelukast has shown promise in earlier small studies and animal research for reducing inflammation and possibly protecting the brain. However, there are concerns about behavioral side effects, especially in older children, which the study will monitor closely. This is the first step in determining if montelukast could be a safer, more effective alternative to steroids for preventing long-term lung damage in fragile preterm infants

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