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

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Bronchopulmonary Dysplasia (BPD), Premature Births, Critical Illness

In brief

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.

Key facts

Study ID

NCT07101640

Run by

Duke University

People needed

28

Starts

2026-02-23

Expected to finish

2028-06-30

Last updated by the study team

2026-07-14

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Able to tolerate 5 mL of enteral volume

You may not qualify if…

• 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
• Has a disease complication that would preclude safe participation of the participant
• Increased respiratory support due to intercurrent illness (e.g., sepsis, necrotizing enterocolitis, etc.). Infants should be excluded from the study until after resolution of the acute event
• Congenital lung and diaphragmatic malformations

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States (enrolling)
• University of Massachusetts — Amherst, Massachusetts, United States (enrolling)
• University Medical Center of Southern Nevada — Las Vegas, Nevada, United States (enrolling)
• University of North Carolina (UNC) — Chapel Hill, North Carolina, United States (enrolling)
• East Carolina University — Greenville, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.