Montelukast for Bronchopulmonary Dysplasia

(PRISM Trial)

This trial examines the safety of montelukast, a medication, for premature infants at high risk for developing Bronchopulmonary Dysplasia (BPD), a serious lung condition. The researchers aim to understand how montelukast moves through and exits the body in these infants. The study includes two groups: one receives montelukast mixed with milk or formula, while the other receives plain milk or formula (placebo). It is suitable for infants born before 28 weeks, weighing less than 1000 grams at birth, and requiring a certain level of oxygen and ventilation support. As a Phase 1/Phase 2 trial, this study focuses on understanding how the treatment works in infants and measuring its effectiveness in a smaller group.

The trial information does not specify whether participants must stop taking their current medications. It is best to discuss this with the trial coordinators or your doctor.

Earlier studies have shown montelukast's potential for treating lung problems in premature babies. Researchers have examined how well these infants tolerate the drug. One study suggested that montelukast is fairly safe when administered orally at the appropriate dose for very premature infants. Although extensive safety data is lacking, the FDA has approved the drug for treating asthma in older children, which offers some reassurance about its safety.

Most treatments for bronchopulmonary dysplasia (BPD) focus on managing symptoms with options like oxygen therapy, diuretics, and corticosteroids. But Montelukast offers a fresh approach by targeting inflammation through leukotriene receptor antagonism. This mechanism can potentially reduce lung inflammation more effectively in infants with BPD. Researchers are excited about Montelukast because it may provide a new way to manage BPD by directly addressing the underlying inflammatory processes, potentially leading to better outcomes for these vulnerable patients.

This trial will compare Montelukast with a placebo to evaluate its effectiveness for premature babies at risk of developing bronchopulmonary dysplasia (BPD), a lung condition. Studies have shown that Montelukast can be beneficial; specifically, research with 206 premature infants suggested it may reduce their need for breathing support. While it doesn't completely prevent BPD, it might improve breathing and reduce symptom severity. In animal studies, Montelukast improved lung structure and function. Although researchers are still determining the best dose, evidence suggests Montelukast could help manage BPD in premature infants.²³⁵⁶⁷