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.
Documented informed consent from parent or guardian, prior to study activities
Receiving mechanical ventilation [high frequency or conventional] and requiring supplemental oxygen (FiO2 ≥ 30%) at time of randomization
<28 weeks' gestational age and <1000 g bodyweight at birth
7 to 28 (inclusive) days postnatal age at the time of first study drug dose
Previous enrollment and dosing in the current PRISM study (NICHD-2023-MON01)
Previous exposure to montelukast within 7 days prior to randomization
Known allergy to montelukast
PI deems infant - prior to enrollment - is not expected to survive
Duke University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
University of North Carolina, Chapel Hill
Collaborator
University Medical Center of Southern Nevada
Collaborator
East Carolina University
Collaborator
University of Massachusetts, Worcester
Collaborator
Arkansas Children's Hospital Research Institute
Collaborator