Actively Recruiting
Pharmacokinetics, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia
Led by Duke University · Updated on 2026-06-02
28
Participants Needed
5
Research Sites
17 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
Researchers are evaluating the safety and how montelukast is processed in the body of premature infants at high risk for Bronchopulmonary Dysplasia (BPD). This study aims to understand the best dose and how quickly the drug moves from the stomach into the bloodstream and is cleared from it. Previous smaller studies suggest montelukast may be promising for preterm infants developing BPD, but the best dose still needs to be determined. The study is a multi-center, randomized, double-blind, placebo-controlled trial involving 28 critically ill premature infants with developing BPD. Participants will receive either montelukast at 0.75 mg/kg once daily or a placebo for 7 days. Montelukast granules are mixed with breast milk or formula for administration. After the 7 days of treatment, infants will be monitored for safety for up to 30 days or until 36 weeks postmenstrual age. Participants will stay in the hospital for up to around 60 days depending on their gestational age and age at enrollment. They will have medical and neurodevelopmental assessments at 6, 12, 18, and 24 months of age to track progress. Researchers will measure how the drug is cleared from the body, its safety, respiratory support changes, and developmental outcomes over two years.
CONDITIONS
Brief 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...
- Documented informed consent from parent or guardian prior to study activities
- Receiving mechanical ventilation (high frequency or conventional) and requiring supplemental oxygen (FiO2 65 30%) at time of randomization
- Born at less than 28 weeks' gestational age and weighing less than 1000 g at birth
- Between 7 and 28 days postnatal age at first study drug dose
- Able to tolerate 5 mL of enteral volume
You will not qualify if you...
- Previous enrollment and dosing in the current PRISM study (NICHD-2023-MON01)
- Exposure to montelukast within 7 days prior to randomization
- Known allergy to montelukast
- Infant not expected to survive as judged by the principal investigator prior to enrollment
- Disease complications that would prevent safe participation
- Increased respiratory support due to acute illness (e.g., sepsis, necrotizing enterocolitis) until resolved
- Congenital lung or diaphragmatic malformations
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants receive once daily montelukast or placebo for 7 days to study its effects on bronchopulmonary dysplasia.
Daily dosing with clinical monitoring during inpatient stay
Duration - Up to approximately 60 days inpatient and 24 months outpatient
Participants are monitored for safety and developmental progress after treatment, including inpatient safety monitoring and outpatient neurodevelopmental assessments.
Approximately 30 days of inpatient safety monitoring plus outpatient visits at 6, 12, 18, and 24 months
Trial Site Locations
Total: 5 locations
1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Actively Recruiting
2
University of Massachusetts
Amherst, Massachusetts, United States, 01003
Actively Recruiting
3
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Actively Recruiting
4
University of North Carolina (UNC)
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
5
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
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