Montelukast for critically ill premature infants developing bronchopulmonary dysplasia: pharmacokinetics, safety, and early efficacy
Pharmacokinetics, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia
PHASE1; PHASE2 · Duke University · NCT07101640
This study gives once-daily montelukast to critically ill premature infants developing bronchopulmonary dysplasia to test how the drug moves through the body, whether it is safe, and whether it helps breathing.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | N/A to 28 Weeks |
| Sex | All |
| Sponsor | Duke University (other) |
| Locations | 4 sites (Little Rock, Arkansas and 3 other locations) |
| Trial ID | NCT07101640 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, randomized, double-masked, placebo-controlled Phase 1/2 trial enrolling 28 critically ill preterm infants to receive once-daily montelukast (0.75 mg/kg/day) or placebo for 7 days. The primary goal is to characterize montelukast pharmacokinetics in infants born <28 weeks' gestation and <1000 g who are 7–28 days old and require mechanical ventilation with FiO2 ≥30%. Secondary and tertiary aims include short- and long-term safety monitoring and preliminary measures of respiratory support needs, with inpatient monitoring up to about 60 days and neurodevelopmental follow-up out to 24 months. The design builds on several small prior pediatric studies but focuses on detailed PK and safety data in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates are critically ill preterm infants born before 28 weeks' gestation and under 1000 g at birth, aged 7–28 days, receiving mechanical ventilation with FiO2 ≥30%, and able to tolerate enteral feeding volumes.
Not a fit: Infants with known montelukast allergy, recent montelukast exposure, major non-survivable conditions, acute intercurrent illnesses that increase respiratory support, or those not requiring significant respiratory support are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, montelukast could reduce lung injury and improve respiratory outcomes for premature infants developing bronchopulmonary dysplasia, potentially decreasing time on ventilators and improving longer-term respiratory and developmental outcomes.
How similar studies have performed: Six small prior studies totaling about 206 preterm infants reported promising signals with montelukast (doses 0.5–2.5 mg/kg/day), but those studies were small and the optimal dose remains uncertain.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Little Rock, Arkansas and 3 other locations
- Arkansas Children's Hospital — Little Rock, Arkansas, United States (RECRUITING)
- University Medical Center of Southern Nevada — Las Vegas, Nevada, United States (RECRUITING)
- University of North Carolina (UNC) — Chapel Hill, North Carolina, United States (RECRUITING)
- East Carolina University — Greenville, North Carolina, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bronchopulmonary Dysplasia, Premature Births, Critical Illness, PK, Pharmacokinetics, bronchopulmonary dysplasia, montelukast