Investigating the safety of sildenafil for premature infants with severe lung disease
Official title: Safety of Sildenafil in Premature Infants with Severe Bronchopulmonary Dysplasia
Funded at Duke University · NIH-10694036 · Data updated 2026-11-12
This study is looking at whether sildenafil can safely help prevent lung problems in premature babies with severe breathing issues, and it involves giving some babies the medication and others a placebo to see how well it works.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Duke University NIH-funded |
| Lab location | 1 site (Durham, United States) |
| Project start | September 15, 2019 |
| Project end | August 31, 2025 |
| Funding year | 2023 |
| Award (this year) | $2,186,920 |
| NIH project number | 5R33HL147833-05 |
| Project ID | NIH-10694036 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 gestation who are diagnosed with severe bronchopulmonary dysplasia.
✕Less likely to help
Patients who are not premature or do not have severe bronchopulmonary dysplasia may not benefit from this research.
What this research studies
This research focuses on the safety and efficacy of sildenafil, a medication that may help prevent pulmonary hypertension in premature infants suffering from severe bronchopulmonary dysplasia (BPD). The study will involve a randomized, placebo-controlled trial where 120 infants under 29 weeks gestation will receive either sildenafil or a placebo for four weeks. The research aims to gather critical data on dosing, safety, and the drug's effects on lung and vascular development in this vulnerable population. By collaborating across 30 clinical sites, the study seeks to address a significant public health need for effective treatments in these infants.
Why it matters
Potential benefit: If successful, this research could lead to a new treatment option that significantly reduces mortality and long-term health issues in premature infants with severe BPD.
How similar studies have gone: While sildenafil has been used in adults with pulmonary hypertension, this specific application in premature infants is novel and has not been extensively tested.
Where this research is happening
-
Duke University
Durham, United States Active
Researchers
- Principal investigator: Hornik, Christoph — Duke University
- Study coordinator: Hornik, Christoph
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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.