Clinically proven: Prapela SVS is as effective as holding to console opioid-exposed newborns. Each hour of SVS delivers a consoling effect statistically equivalent to an hour of caregiver holding — providing continuous, passive soothing that reduces caregiver burden without interrupting care.
Designed for use in any hospital unit where opioid-exposed newborns are treated, the Prapela SVS pad delivers gentle random (stochastic) vibration therapy that engages the somatosensory system to provide continuous, sub-arousal sensory input to brainstem autonomic networks — the same neural pathways responsible for regulating breathing rhythm and cardiorespiratory stability.
Imperceptible vibrations delivered at random (stochastic) intervals stimulate the newborn's nervous system, reducing withdrawal symptom severity.
The sole device granted FDA authorization for treatment of opioid-exposed newborns — placing it in a class of one.
Works synergistically with ESC (Eat, Sleep, Console) protocols as an adjunct to caregiver holding and skin-to-skin care — providing continuous consoling support during the hours when holding is unavailable.
Fits standard hospital bassinets. Designed for use wherever opioid-exposed newborns are treated — NICU, step-down, and general newborn care units — with minimal setup and training burden on nursing staff.
NOWS is the most serious consequence of in-utero opioid exposure. Affected newborns face hyperirritability, sleep disruption, tremors, feeding difficulty, and more — with hospital stays averaging 9–16 days.
Diagnosis requires in-utero opioid exposure confirmed by history, plus at least two clinical signs of withdrawal — most commonly excessive crying, fragmented sleep, tremors, and increased muscle tone.
* ESC-based management reduces median hospital LOS by 47–60% vs. traditional pharmacological protocols (Young et al., NEJM 2023; Chu et al., Front Pediatr 2024). Prapela SVS is designed to extend ESC by providing continuous, hands-free consoling equivalent to caregiver holding during periods when holding is unavailable.
SVS targets the brainstem autonomic networks
responsible for breathing rhythm and
cardiorespiratory stability in opioid-exposed newborns
Stochastic Vibrotactile Stimulation leverages neuroscience to calm the overstimulated newborn nervous system — not by masking symptoms, but by stabilizing the underlying neural pathways.
The pad emits low-amplitude, random-interval vibrations — below the threshold of conscious perception — that engage the somatosensory system without triggering arousal.
Continuous, sub-arousal sensory input reaches the brainstem autonomic networks responsible for regulating breathing rhythm and cardiorespiratory stability — the neural pathways disrupted by opioid withdrawal.
Stochastic resonance stabilizes the destabilized biological system — reducing hyperirritability, normalizing heart and breathing rates, and delivering consoling equivalent to an hour of caregiver holding per hour of SVS. (Bloch-Salisbury et al., JAMA Pediatrics 2023; Zuzarte et al., PLoS ONE 2017)
Clinicians evaluating motion-based or sound-based bassinet devices for opioid-exposed newborns should understand a critical distinction: device type, mechanism, and regulatory status matter.
e.g., automated side-to-side rocking + white noise devices
Robinson TW et al. Am J Perinatol. 2024;41(16):2198–2205.
Stochastic Vibrotactile Stimulation — FDA De Novo Authorized
Bloch-Salisbury et al. JAMA Pediatrics, 2023;177(7):665–674.
Clinical bottom line: Not all motion-based bassinet devices are equivalent. The stochastic resonance mechanism of Prapela SVS — low-amplitude, sub-arousal, random vibration — is designed to stabilize the hyperaroused neonatal nervous system, not stimulate it further. Prapela SVS is the only bassinet device with FDA authorization for opioid-exposed newborns and peer-reviewed RCT evidence from JAMA Pediatrics supporting its use in this population.
Randomized controlled trial demonstrating statistically significant reductions in Finnegan/ESC scores in opioid-exposed newborns treated with SVS adjunctive therapy.
Exploration of the neurophysiological basis for SVS efficacy, drawing on stochastic resonance theory and neonatal sensory-motor development literature.
Preliminary data from Prapela's ongoing clinical trial program investigating the effect of SVS on apneic event frequency in preterm infants. (Investigational — not FDA authorized for this use.)
Building on the proven SVS mechanism, Prapela is conducting clinical research into a new indication: Apnea of Prematurity (AOP) — a condition affecting premature infants in which breathing temporarily stops during sleep.
AOP occurs in premature infants whose brainstem respiratory control is not fully developed, causing recurrent pauses in breathing lasting ≥20 seconds, often with bradycardia or oxygen desaturation.
Stochastic vibrotactile stimulation may support respiratory regularity by stimulating the developing nervous system — similar to its established effect in NOWS. The SVS mechanism of action reduces apneic events by enhancing central sensory-motor feedback.
Prapela is currently conducting a clinical trial to evaluate SVS efficacy for AOP under a Non-Significant Risk (NSR) assessment — a designation that reflects the established safety profile of the device. Investigators and clinical teams at hospitals treating premature infants are encouraged to reach out about participation.
Our clinical team is available to walk you through device specs, implementation support, clinical evidence, and ordering. We're also available to discuss research partnerships for the AOP trial.
Clinical evidence review — peer-reviewed literature supporting SVS efficacy and FDA authorization
In-service training and implementation guidance
Hospital Savings Calculator — quantify your institution's potential cost savings from reduced NAS/NOWS length of stay (available upon request)
AOP trial enrollment inquiries and site qualification
Currently shipping to US healthcare facilities
