Investigating the use of montelukast to prevent bronchopulmonary dysplasia in premature infants

PRISM

NIH-funded research Duke University · NIH-10930088

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 typeR01 grant
Study typeNIH-funded research
Funding institutionDuke University NIH-funded
Lab location1 site (Durham, United States)
Project IDNIH-10930088 on NIH RePORTER

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.

Who could benefit from this research

Good fit: 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.

Not a fit: Patients who are not premature or those who do not require positive pressure ventilation may not benefit from this research.

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 performed: 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

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.