One in nine live births in the U.S is preterm and these high risk births require specialized monitoring and treatment in neonatal intensive care units. Cardio-respiratory events are common in preterm infants that can range from benign periodic apnea with mild oxygen desaturations and cardiac decelerations to severe life-threatening apnea events requiring mechanical ventilation.
The monetary amount to treat the high number of premature infants born that require some form of neonatal intervention plus their combined healthcare costs are over $25 billion annually in the U.S. alone. For extended stays in NICUs, each day of NICU care can cost in excess of $4000 in the U.S and it is not unusual for the total cost of one infant in the NICU to exceed $1 million.
To address the problem, research clinicians and engineers at the Wyss Institute for Biologically Inspired Engineering at Harvard University and at the University of Massachusetts Medical School have developed a system they hope will be effective in predicting and preventing the onset of neonatal apnea in low birth weight infants.
The system uses Stochastic Resonance (SR) that gently applies vibration to the infant. The system monitors the infant’s heart rate, breathing patterns, and other physiological signals, and uses proprietary algorithms to identify unique patterns that are predictors for breathing disruption or cessation.
Once an apnea event is anticipated and identified, the system activates a precisely tuned gentle SR vibration in the mattress to prevent the event without interrupting the sleep pattern of the infant. The researchers hope that the technology will be deployed as an FDA-approved medical device with non-contact sensors embedded within the mattress capable of monitoring the infant’s cardio-respiratory signals without attaching leads to the infant.
Positive preliminary preclinical results show that this system is effective at reducing both the number and severity of apnea events as well as reducing the duration and severity of oxygen desaturations for infants in critical care settings.
The system works by having signals go into an on-board processor inside the mattress. Algorithms running on the processor then use the signals to predict apnea events and control the vibrational stimulation applied to the infant to prevent apnea events from occurring. After, the baby is discharged from the hospital, the mattress can be sent home with the family to prevent apnea in a home environment but if an emergency occurs, alarms would be sent to a parent’s mobile device.
Initial commercial target markets for the system are likely to be NICUs located at the 2000 advanced care hospitals in the U.S. Also, future versions of the technology could target the home market or markets in developing countries.
Wyss has developed an extensive broad patent and intellectual property portfolio covering the system, the algorithms, the software, the signal processing, and therapeutic interventions. For more information, email Alan Gordon at alan_gordon@harvard.edu or call 617-384-5000.