Using theophylline to prevent kidney damage in newborns during cooling treatment
Official title: Theophylline Prophylaxis during Hypothermia to Limit Neonatal Nephron Damage
Funded at Medical College of Wisconsin · NIH-11115598 · Data updated 2026-11-12
This study is looking at whether giving theophylline, a medication, to newborns with brain injury who are being cooled for treatment can help protect their kidneys and reduce the chances of kidney problems or death.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Medical College of Wisconsin NIH-funded |
| Lab location | 1 site (Milwaukee, United States) |
| Project start | April 1, 2023 |
| Project end | March 31, 2026 |
| Funding year | 2025 |
| Award (this year) | $252,000 |
| NIH project number | 5R01DK133197-03 |
| Project ID | NIH-11115598 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are infants over 35 weeks gestation diagnosed with hypoxic-ischemic encephalopathy who are receiving therapeutic hypothermia.
✕Less likely to help
Patients who are not diagnosed with hypoxic-ischemic encephalopathy or those born before 35 weeks gestation may not benefit from this research.
What this research studies
This research investigates the use of theophylline, a medication, to prevent acute kidney injury (AKI) in infants diagnosed with hypoxic-ischemic encephalopathy (HIE) who are undergoing therapeutic hypothermia. The study aims to determine if administering theophylline within the first 12 hours after birth can reduce the incidence and severity of AKI or death in these infants. By conducting a pilot trial, the researchers will assess the feasibility of recruitment and adherence to protocols, as well as the effectiveness of measuring clinical outcomes related to kidney health over a two-year period. This approach is essential to establish a foundation for a larger clinical trial in the future.
Why it matters
Potential benefit: If successful, this research could lead to a new preventive treatment for kidney injury in vulnerable newborns, potentially improving their long-term health outcomes.
How similar studies have gone: Previous small trials have suggested that theophylline may help reduce AKI in similar patient populations, but this specific approach in conjunction with therapeutic hypothermia is novel.
Where this research is happening
-
Medical College of Wisconsin
Milwaukee, United States Active
Researchers
- Principal investigator: Segar, Jeffrey L — Medical College of Wisconsin
- Study coordinator: Segar, Jeffrey L
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.