NCT07101640 PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia
| NCT ID | NCT07101640 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Duke University |
| Condition | Bronchopulmonary Dysplasia (BPD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2026-02-23 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 28 participants in total. It began in 2026-02-23 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT07101640 clinical trial?
This trial is open to participants of all sexes, aged 7 Days or older, up to 28 Days, studying Bronchopulmonary Dysplasia (BPD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07101640 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07101640 currently recruiting?
Yes, NCT07101640 is actively recruiting participants. Visit ClinicalTrials.gov or contact Duke University to inquire about joining.
Where is the NCT07101640 trial being conducted?
This trial is being conducted at Little Rock, United States, Amherst, United States, Las Vegas, United States, Chapel Hill, United States and 1 additional location.
Who is sponsoring the NCT07101640 clinical trial?
NCT07101640 is sponsored by Duke University. The trial plans to enroll 28 participants.