"One of the major concerns for the medical staff in the NICU is that infants can develop a life-threatening infection before there are any apparent signs of illness, said Dr. Pam Griffin, co-author and former UVa Health System neonatologist and now senior director of clinical development at MedImmune Corporation, "so continuous monitoring for infection is potentially a very useful addition to our management of these vulnerable patients."
Dr. Randall Moorman, study co-author and cardiologist at the UVa Health System, was instrumental in developing the novel bedside monitoring system to predict the likelihood that sepsis will occur in a baby in the next 24 hours. The new system analyzes heartbeat signals obtained from a standard bedside heart rate monitor and looks for patterns that give an early indication that the baby is getting sick. Characteristics such as decreased variability of the heart rate along with brief episodes of slowing of the heart rate indicate that the infant may be getting an infection. These characteristic patterns can serve as an early warning to the physicians and nurses caring for the infants.
"At UVa we found characteristic heart rate patterns in infants twelve or more hours before they were known to be infected, and we designed a computer program to detect these patterns," said Moorman. "We worked with colleagues at Wake Forest to be sure that these heart rate characteristics typical of illness happened in sick infants elsewhere."
Now after years of testing and clearance from the Food and Drug Administration, academic research hospitals are participating in a multi-center National Institutes of Health-sponsored study to further test if heart rate characteristic monitoring improves outcomes for NICU babies.
"My expectation is that the continuous monitoring of heart rate characteristics will allow clinicians to identify and treat infected infants sooner, and that earlier initiation of treatment will decrease the severity of the illness and improve the infant's outcome," said Dr. Mike O'Shea, MD, MPH, professor of pediatrics at Wake Forest University Health Sciences Center.
The patented monitoring technology was developed by Griffin and Moorman at the University of Virginia Health System. The rights are licensed by the University of Virginia Health System Patent Foundation to Medical Predictive Sciences Corporation in Charlottesville, Virginia. Griffin and Moorman have an equity share. The multi-centered study is funded through a 5-year, $2.5 million NIH grant.