Rapid, at-a-glance test to guide newborn infection therapy
Official title: Rapid Test to Assist Therapy in Neonatal Sepsis and Necrotizing Enterocolitis
Funded at Prothera Biologics, LLC · NIH-11324963 · Data updated 2026-11-12
A quick blood test using IAIP levels to help decide early on whether a newborn is at risk for sepsis or NEC and should continue or adjust antibiotics.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Prothera Biologics, LLC NIH-funded |
| Lab location | 1 site (Providence, United States) |
| Project start | August 15, 2018 |
| Project end | March 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $954,189 |
| NIH project number | 5R44AI141283-06 |
| Project ID | NIH-11324963 on NIH RePORTER |
Who could benefit from this research
✓Could help
Infants in NICUs evaluated for suspected neonatal sepsis or NEC risk, particularly those with inconclusive standard test results.
✕Less likely to help
Infants without infection risk or those not requiring antibiotic decisions may not directly benefit from this test.
What this research studies
This project aims to bring a fast point-of-care IAIP-based test to bedside use in NICUs, delivering results in about 15 minutes to guide treatment for suspected neonatal infections. It builds on prior SBIR work showing high accuracy and rapid turnaround, comparing IAIP levels to standard lab markers. The study emphasizes real-world use with critically ill infants and seeks to demonstrate predictive value for NS and NEC across NICU populations. By enabling earlier, better-informed antibiotic decisions, it could reduce unnecessary treatment and improve outcomes for newborns.
Why it matters
Potential benefit: If successful, the test could enable faster, more accurate decisions about starting or stopping antibiotics in newborns with suspected infections, potentially reducing harm from unnecessary exposure and improving survival and outcomes.
How similar studies have gone: Previous SBIR Phase II work demonstrated high predictive value and rapid IAIP testing with strong ROC performance in NICU samples.
Where this research is happening
-
Prothera Biologics, LLC
Providence, United States Active
Researchers
- Principal investigator: Lim, Yow-Pin — Prothera Biologics, LLC
- Study coordinator: Lim, Yow-Pin
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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.