Actively Recruiting
PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia
Led by Duke University · Updated on 2026-03-06
28
Participants Needed
4
Research Sites
118 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent or guardian has given documented informed consent before any study activities
- Baby is receiving mechanical ventilation (high frequency or conventional) and supplemental oxygen at 30% or more at randomization
- Baby was born before 28 weeks gestation and weighed less than 1000 grams at birth
- Baby is between 7 and 28 days old at the time of the first study drug dose
- Baby can tolerate at least 5 mL of enteral feeding
You will not qualify if you...
- Baby has already been enrolled and dosed in the current PRISM study (NICHD-2023-MON01)
- Baby has received montelukast in the 7 days before randomization
- Known allergy to montelukast
- Investigator believes baby is not expected to survive before enrollment
- Baby has a disease complication that would make participation unsafe
- Baby has increased respiratory support needs due to an acute illness like sepsis or necrotizing enterocolitis; must wait until recovery
- Baby has congenital lung or diaphragmatic malformations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Actively Recruiting
2
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Actively Recruiting
3
University of North Carolina (UNC)
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
4
East Carolina University
Greenville, North Carolina, United States, 27858
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here