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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Duke University
Study ID
NCT07101640
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Bronchopulmonary Dysplasia (BPD)
  • Critical Illness
  • Premature Births

Eligibility Criteria

Sex
ALL
Age
7 Days - 28 Days
Healthy Volunteers
Not accepted

Interventions

  • montelukast 4 mg granule — DRUG
    Montelukast sodium (4 mg oral granules) dissolved into 5mL of breast milk/formula yielding a solution concentration of 0.8mg/mL. Dosed once daily by weight, montelukast (0.75 mg/kg/day) or placebo .
  • Placebo — DRUG
    Plain breast milk or formula

Study Details

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 Dates

Start date
Feb 23, 2026
Status verified
Mar 2026
Primary completion
Mar 1, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
28 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Montelukast Sodium
    Once daily montelukast dosed at 0.75 mg/kg/day, maximum dose 4mg. 4mg of montelukast mixed in 5mlL breast milk/formula for a concentration of 0.8mg/mL.
  • Placebo Comparator: Placebo
    Plain breast milk or formula

Primary Outcome Measure

Apparent clearance (CL/F) of montelukast [ Time Frame: From enrollment to 14 days post first dose. ]

Locations (5)

FacilityCityStateZIPSite coordinators
Arkansas Children's HospitalLittle RockArkansas72202
Ankita Shukla, MD
[email protected]
501-364-1100
University of MassachusettsAmherstMassachusetts01003
Madeline French, MBE
[email protected]
508-334-6180
Lawrence Rhein, MD (PRINCIPAL_INVESTIGATOR)
University Medical Center of Southern NevadaLas VegasNevada89102
Francis Banfro, MD
[email protected]
323-376-2369
University of North Carolina (UNC)Chapel HillNorth Carolina27599
Wesley Jackson, MD
[email protected]
984-215-3449
East Carolina UniversityGreenvilleNorth Carolina27858
Ryan Moore, MD
[email protected]
252-814-8415

Find similar trials in Little Rock, AR

By research site
Arkansas Children's Hospital· Little Rock, ARUniversity of Massachusetts· Amherst, MAUniversity Medical Center of Southern Nevada· Las Vegas, NVUniversity of North Carolina (UNC)· Chapel Hill, NCEast Carolina University· Greenville, NC

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