PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developin… (NCT07101640) | Clinical Trial Compass
RecruitingPhase 1/2
PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia
United States28 participantsStarted 2026-02-23
Plain-language summary
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.
Who can participate
Age range28 Weeks
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Apparent clearance (CL/F) of montelukast
Timeframe: From enrollment to 14 days post first dose.
✕. 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