Investigating the use of montelukast to prevent bronchopulmonary dysplasia in premature infants
Official title: PRISM
Funded at Duke University · NIH-10930088 · Data updated 2026-11-12
This study is looking at how well the medication montelukast can help prevent lung problems in premature babies born before 29 weeks, and it will test different doses to find the safest and most effective amount to use.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Duke University NIH-funded |
| Lab location | 1 site (Durham, United States) |
| Project start | September 15, 2023 |
| Project end | June 30, 2028 |
| Funding year | 2024 |
| Award (this year) | $656,285 |
| NIH project number | 5R01HD113201-02 |
| Project ID | NIH-10930088 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are premature infants born at less than 29 weeks of gestation who are at high risk for developing bronchopulmonary dysplasia.
✕Less likely to help
Patients who are not premature or those who do not require positive pressure ventilation may not benefit from this research.
What this research studies
This research focuses on the use of montelukast, an FDA-approved anti-inflammatory medication, to prevent bronchopulmonary dysplasia (BPD) in premature infants. The study will involve a dose-escalating trial where infants born before 29 weeks of gestation will receive varying doses of montelukast over a four-week period. The goal is to determine the optimal dose that is both safe and effective in reducing the risk of developing BPD. The research will be conducted at multiple neonatal sites, with careful monitoring of safety and drug clearance.
Why it matters
Potential benefit: If successful, this research could significantly reduce the incidence of bronchopulmonary dysplasia in premature infants, improving their long-term respiratory health.
How similar studies have gone: Previous small neonatal trials have shown promise for montelukast in this context, but this specific approach is novel and aims to establish optimal dosing.
Where this research is happening
-
Duke University
Durham, United States Active
Researchers
- Principal investigator: Lang, Jason E. — Duke University
- Study coordinator: Lang, Jason E.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.