Safety and Pharmacokinetics of Montelukast in Premature Infants with Developing Bronchopulmonary Dysplasia Randomized, Placebo-Controlled Study of Montelukast in Critically Ill Preterm Infants

What this Trial Is About

Researchers are studying the safety and how montelukast moves through the body in premature infants who are at high risk for Bronchopulmonary Dysplasia BPD. This study is a randomized, double-blinded, placebo-controlled trial involving critically ill premature infants with developing BPD. Previous smaller studies suggest montelukast may help these infants, but the best dose is still unknown, so this study starts with a low dose to assess safety and pharmacokinetics. Participants will receive either montelukast once daily at 0.75 mgkg or a placebo plain breast milk or formula for 7 days. Montelukast is given as 4 mg granules mixed in 5 mL of breast milk or formula to reach a concentration of 0.8 mgmL. The study includes an inpatient period lasting up to about 60 days, which covers the 7 days of treatment plus 30 days of safety monitoring or until the infant reaches 36 weeks postmenstrual age, whichever is longer. After discharge, infants will have medical and developmental follow-ups at 6, 12, 18, and 24 months old. During the study, infants will be closely monitored for how montelukast is absorbed, distributed, and eliminated, as well as safety outcomes like adverse events and respiratory support changes. Researchers will also assess long-term neurodevelopmental progress up to 24 months. Various measurements include montelukast clearance, volume distribution, half-life, and oxygen saturation index during treatment. Safety evaluations continue through 30 days after treatment or 36 weeks postmenstrual age, with extended developmental assessments during outpatient visits.

PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia