Recruiting
Phase 1
Phase 2

Montelukast

Sponsor:

Duke University

Code:

NCT07101640

Conditions

Bronchopulmonary Dysplasia (BPD)

Premature Births

Critical Illness

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

montelukast 4 mg granule

Placebo

Study Details

Brief 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.

Conditions

Bronchopulmonary Dysplasia (BPD)

Premature Births

Critical Illness

Study ID

NCT07101640

Start date

Feb 23, 2026

Status verified date

Mar, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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 .

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. ]

Central Contacts and Locations

Locations

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Ankita Shukla, MD

501-364-1100DaniellA@archildrens.org

University of Massachusetts

Recruiting

Amherst, Massachusetts, United States, 01003

Contacts

Madeline French, MBE

(508) 334-6180Madeline.French2@umassmed.edu

Principal Investigator:

Lawrence Rhein, MD

University Medical Center of Southern Nevada

Recruiting

Las Vegas, Nevada, United States, 89102

Contacts

Francis Banfro, MD

323-376-2369robert.bimbi@umcsn.com

University of North Carolina (UNC)

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Wesley Jackson, MD

984-215-3449Traci_Clark@med.unc.edu

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27858

Contacts

Ryan Moore, MD

252-814-8415moseleysh@ecu.edu

More Information

Sponsor

Duke University

Last update posted

Jul 14, 2026

Last verified

Mar, 2026

Keywords

  • PK
  • Pharmacokinetics
  • bronchopulmonary dysplasia
  • montelukast

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Duke University on 2026-07-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.