Montelukast for Bronchopulmonary Dysplasia
(PRISM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Montelukast
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Once daily montelukast dosed at 0.75 mg/kg/day, maximum dose 4mg. 4mg of montelukast mixed in 5mlL breast milk/formula for a concentration of 0.8mg/mL.
Plain breast milk or formula
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
University Medical Center of Southern Nevada
Collaborator
East Carolina University
Collaborator
University of Massachusetts, Worcester
Collaborator
Arkansas Children's Hospital Research Institute
Collaborator
University of North Carolina, Chapel Hill
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
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