NCT07101640View on ClinicalTrials.gov

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

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

May 31, 2028

Conditions
Bronchopulmonary Dysplasia (BPD)Premature BirthsCritical Illness
Interventions
DRUG

montelukast 4 mg granule

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 .

DRUG

Placebo

Plain breast milk or formula

Sponsors

Lead Sponsor

Duke University
All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

University of North Carolina, Chapel Hill

OTHER

lead

Duke University

OTHER

NCT07101640 - PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia | Biotech Hunter | Biotech Hunter