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PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia
Pharmacokinetics, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia
Who can join
7 Days – 28 Days · All sexes
Full eligibility criteria
Inclusion Criteria 1. Documented informed consent from parent or guardian, prior to study activities 2. Receiving mechanical ventilation \[high frequency or conventional\] and requiring supplemental oxygen (FiO2 ≥ 30%) at time of randomization 3. \<28 weeks' gestational age and \<1000 g bodyweight at birth 4. 7 to 28 (inclusive) days postnatal age at the time of first study drug dose 5. Able to tolerate 5 mL of enteral volume Exclusion Criteria 1. Previous enrollment and dosing in the current PRISM study (NICHD-2023-MON01) 2. Previous exposure to montelukast within 7 days prior to randomization 3. Known allergy to montelukast 4. PI deems infant - prior to enrollment - is not expected to survive 5. Has a disease complication that would preclude safe participation of the participant 6. 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 7. Congenital lung and diaphragmatic malformations
About the study
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.
What is being tested
- montelukast 4 mg granule (drug)
- Placebo (drug)
Sponsor: Duke University · Participants: 28 · Started: Feb 23, 2026
Contact the study team
Official record on ClinicalTrials.gov — NCT07101640
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.