Early warning monitors for very small premature babies in the NICU

Predictive informatics monitoring in the Neonatal Intensive Care Unit

['FUNDING_R01'] · UNIVERSITY OF VIRGINIA · NIH-11327642

Uses advanced computer analysis of bedside monitor data to find early signs of infection and serious gut disease in very low birth weight premature infants.

Quick facts

Phase['FUNDING_R01']
Study typeNih_funding
SexAll
SponsorUNIVERSITY OF VIRGINIA (nih funded)
Locations1 site (CHARLOTTESVILLE, UNITED STATES)
Trial IDNIH-11327642 on ClinicalTrials.gov

What this research studies

This project uses the same bedside monitor data that already watch your baby—heart rate and oxygen levels—and applies advanced time-series and machine-learning methods to spot subtle changes before symptoms appear. The team builds on the HeRO monitor, which previously reduced sepsis deaths, and is adding oxygen saturation patterns and combined heart rate–SpO2 trends to improve early detection of sepsis and necrotizing enterocolitis (NEC). Researchers are testing these algorithms across different hospitals to make sure they work for babies with different demographics and care practices. If your baby is in a participating NICU, the goal is to provide earlier alerts so clinicians can act sooner.

Who could benefit from this research

Good fit: Ideal candidates are very low birth weight (VLBW) premature infants cared for in participating neonatal intensive care units who have continuous bedside monitoring.

Not a fit: Full-term infants, babies not admitted to a participating NICU, or infants without continuous monitor data are unlikely to benefit from this project.

Why it matters

Potential benefit: Could enable earlier alarms and treatment for sepsis or NEC, potentially reducing deaths and long-term complications in very small premature infants.

How similar studies have performed: A prior randomized trial of the HeRO monitor reduced sepsis-related mortality by about 40% in 3,003 VLBW infants, and this project builds on that successful approach.

Where this research is happening

CHARLOTTESVILLE, 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.

View on NIH RePORTER →

Last reviewed 2026-05-15 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.