Montelukast for critically ill premature infants developing bronchopulmonary dysplasia: pharmacokinetics, safety, and early efficacy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Arkansas Children's Hospital
  Little Rock, Arkansas, United States Recruiting
• University of Massachusetts
  Amherst, Massachusetts, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.