HeRO™ Clinical Trial Passes Another Milestone: 2,150 Patients Enrolled

April 30, 2009 - Charlottesville, VA: In a groundbreaking clinical trial evaluating the outcomes of patient monitored by the HeRO™ System, Medical Predictive Science Corporation (MPSC) announced that 2,150 very low birthweight (VLBW) neonates have been enrolled to date.  Jointly s ponsored by the National Institutes of Health and MPSC, this randomized controlled trial will enroll a total 3,000 premature infants, and evaluate the HeRO System's impact on length of stay, mechanical ventilation, antibiotic usage, and mortality.

In the world of treating neonatal infants, there is a relative paucity of large cohort clinical trials designed to provide evidence of a new intervention's effectiveness when compared tothe existing standard of care (i.e. evidence based medicine).  The large HeRO trial aims to specifically demonstrate the improvement in patient outcomes when the HeRO Score is available to the health care professionals tending to these infants.  The results of the trial will specifically evaluate relevant outcomes measures used by clinicians to design improved standards of care for these infants.   

Medical Predictive Science Corporation has developed the Heart Rate Observation System™ (HeRO) for analyzing heart rate characteristics.  The HeRO Score is a noninvasive measure that is continuously available to the health care staff caring for the neonates and has been cleared for the purposes of identifying transient decelerations and reduced baseline variability.

Other neonatal advances promulgated through evidence based medicine trials include the adoption of the use of surfactant, now the standard of care for infants for prevention and treatment of respiratory distress.  That advance was supported by similarly designed clinical trials which demonstrated substantial improvements in outcomes.   

"We are very encouraged by the rate of enrollment in this trial and fully expect completion in 2010,” said Will King, CEO of MPSC, “We are committed to providing clinical decision support systems that will advance physicians’ capabilities to treat their patients earlier in the course of disease.”