Research & Grants
Our investigational device is not available for sale in the United States. With hundreds of infants and their parents contributing to past and current studies, we are building the evidence to support regulatory clearance for several newborn medical conditions.
"Use of SVS Device to Improve Outcomes for Neonatal Opioid Withdrawal Syndrome" is an ongoing study led by Tufts Medical Center with support from 5 other hospitals. The research is made possible by a grant from the National Institute of Drug Abuse (NIDA).
"Efficacy of a Vibrating Crib Mattress to Reduce Pharmacological Treatment in Opioid-Exposed Newborns," published in JAMA Pediatrics, shows the effectiveness of Prapela's stimulation in reducing morphine and hospital length of stay in opioid-exposed babies.
"Vibrotactile Stimulation: A non-pharmacological intervention for opioid-exposed newborns," provides early evidence of the ability of Prapela's technology to improve relaxation, breathing, and heart rate in opioid-exposed newborns.
"Stochastic Resonance Effects on Apnea, Bradycardia, and Oxygenation: A Randomized Controlled Trial," published in Pediatrics, the Journal of the American Academy of Pediatrics, demonstrated the effectiveness of Prapela's stimulation on apneic events and associated low oxygenation and slow heart rates.
"Stabilizing immature breathing patterns of preterm infants using stochastic mechanosensory stimulation" provides early evidence that Prapela's stimulation is so gentle that it does not interrupt sleep cycles in preterm newborns.
Apnea of Prematurity - A new randomized clinical trial documenting the effectiveness of Prapela's stimulation in reducing apneic episodes in preterm newborns is planned for early 2024, thanks to a grant from the National Institutes of Health, Blueprint Neuroscience program.
"Prapela SVS: A cost-effective stochastic vibrotactile stimulation device to improve the clinical course of infants with neonatal abstinence syndrome." This Phase I SBIR grant from NIH/NIDA demonstrated the technical and commercial feasibility of converting a clinically tested technology into a medical device.
"Prapela SVS: A cost-effective stochastic vibrotactile stimulation device to improve the clinical course of infants with neonatal abstinence syndrome." Our Phase II SBIR grant from NIH/NIDA is an active project to establish the safety, efficacy, and acceptability of our SVS hospital bassinet pad as a low-cost medical device for use in the hospital to improve the clinical course of newborns with neonatal opioid withdrawal syndrome (NOWS).
"Prapela® SVS incubator pad: A cost-effective stochastic vibrotactile device to improve the clinical course of infants with apnea of prematurity." This Fast-Track SBIR grant from the NIH Blueprint program is to complete the development of and establish the safety, efficacy, and clinical risk/benefit of our hospital incubator pad that will provide a complementary treatment and the first improvement in the clinical management of apnea of prematurity in over 20 years.
Preterm infants often have intermittent hypoxemia or episodic drops in the saturation of oxygen-carrying hemoglobin measured by pulse oximetry. "Prapela pad: A cost-effective stochastic vibrotactile device to improve the clinical course of preterm infants with intermittent hypoxemia.," was recently submitted as a Fast-Track grant to the NIH. The project will complete the development and establish the safety, efficacy, and clinical benefit of a low-cost stochastically vibrating pad to reduce hypoxemic episodes in preterm newborns.