PRISM: Finding the Best Dose of Montelukast to Prevent Lung Disease in Premature Babies

PRISM

NIH-funded research Duke University · NIH-11145659

This project looks for the safest and most effective dose of an existing medicine, montelukast, to help prevent a serious lung condition called bronchopulmonary dysplasia in very premature infants.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionDuke University NIH-funded
Lab location1 site (Durham, United States)
Project IDNIH-11145659 on NIH RePORTER

What this research studies

Bronchopulmonary dysplasia (BPD) is a severe lung problem that often affects babies born very early, and it can be life-threatening. This project explores whether montelukast, a medicine already approved for other uses, can help prevent BPD in premature infants. Researchers will give different doses of montelukast to babies born before 29 weeks who are at high risk for BPD, carefully watching for safety and how the medicine works in their bodies. The goal is to find the best dose to use in a larger future project to confirm if it can prevent BPD.

Who could benefit from this research

Good fit: Ideal candidates for this project are premature infants born before 29 weeks of gestation who require breathing support between 29 and 33 weeks.

Not a fit: Infants who are not premature or who do not have a high risk for bronchopulmonary dysplasia would not be candidates for this specific project.

Why it matters

Potential benefit: If successful, this work could lead to a new way to prevent a serious lung condition in premature infants, potentially improving their long-term health.

How similar studies have performed: Montelukast is an FDA-approved medicine that has shown early promise in smaller projects involving newborns, suggesting a potential benefit for this condition.

Where this research is happening

Durham, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.