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

The purpose of the study is to learn how safe montelukast may be in premature infants at significant risk for Bronchopulmonary Dysplasia (BPD) and to determine how much and how quickly montelukast moves from the stomach into the bloodstream, and how quickly it is removed from the bloodstream. Data supporting the prospect of montelukast benefit involved 6 previous studies involving 206 preterm infants. The dosing ranged from 0.5 to 2.5 mg/kg/day, which aligns with the proposed initial dose of 0.75 mg/kg/day. Though each previous study had a small population, collectively they reveal montelukast as a promising drug in populations of preterm infants developing BPD and for individual preterm infants who are "developing BPD." Thus, researchers expect clinical benefit for preterm infants in this study. Despite the benefit-to-risk ratio presented by these previous studies, the optimal dose remains to be determined; thus, this study design and PK analysis will start with the lowest dose that is likely to provide direct benefit to participants.

NCT Number	NCT07101640
Lead Sponsor	Duke University Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of North Carolina, Chapel Hill, University Medical Center of Southern Nevada, East Carolina University, University of Massachusetts, Worcester, Arkansas Children's Hospital Research Institute
Conditions	Bronchopulmonary Dysplasia (BPD), Premature Births, Critical Illness
Enrollment	28 participants
Start Date	2026-02-23
Primary Completion	2027-06-01 (estimated)
Study Completion	2028-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-14