To a mother, nothing compares to the feeling of holding her newborn in her arms for the first time. As an expectant mother, Kate’s heart brimmed with joy, and she could hardly contain the excitement as she grew nearer to that feeling. However, fate had something else in store for her. While she delivered a baby boy without any major complication, instead of being able to carry him in her arms, she saw him being rushed to the Neonatal Intensive Care Unit afflicted with Neonatal Abstinence Syndrome (NAS). Kate did not prepare for her grim luck; she could not bear to see her child seize every hour, cry profusely, refuse to eat or sleep, and shiver uncontrollably. The reason behind this unexpected turn of events was all the worse for Kate—it was due to her long history of substance abuse. Caught in the clasps of opioid addiction, Kate often resorted to overdosing on the drug for comfort, even while pregnant. Little did she know that down the line, her dependency on the narcotic would have such gruesome repercussions. Not only is Kate the victim here, so is the infant. The unfortunate fact is such cases are not rare. Kate’s story echoes the tragedy of hundreds and thousands of Americans who either overdose for pleasure or gradually give in to the habit after long-term medications for curing different ailments.
In an attempt to help every baby breathe and relax, Massachusetts-based Prapela-an infant sleep tech company-is integrating stochastic vibrotactile technology into medical and consumer products that improve infant health. The co-founder and CEO of the company, John Konsin draws a connection between his inspiration for creating Prapela and the harrowing experience he was subject to while reviving his stepson from a near-fatal overdose. Having spent a majority of his life working on the identification, development, and introduction of new medical and consumer products, Konsin understands the impact of the opioid epidemic on the lives of children and is strongly driven by the desire to help ease the pain of withdrawal experienced by drug-exposed infants. “Opioids hijack your brain. Beating addiction is hard. Beating it while caring for a newborn exposed to the drugs you took during pregnancy is near-impossible,” he emphasizes.
A Novel Approach to Comforting Hyperirritable Infants
Prapela’s ingenious product suite comprises Prapela SVS Baby Box, Prapela Baby Box, and Prapela SVS Hospital Bassinet Pad. The baby box serves as first aid for fussy babies and consoles hyperirritable infants with Stochastic Vibrotactile Stimulation (SVS)—a gentle, random vibration. Konsin mentions, “Neonatal Abstinence Syndrome is a problem that has significant short-term and long-term consequences for Medicaid. More than 50,000 newborns will be treated for in utero drug exposure this year at the cost of $3 billion to our healthcare system.” As such, the PRAPELA SVS BABY BOX is geared toward meeting the needs of these newborns and their caregivers before, during, and after withdrawal, reducing costs and improving care in the process.
The Prapela SVS baby box is a comfortable and safe space to help calm drug-exposed infants and can be used until a child begins to push on her hands and knees or has reached 25 pounds (usually around five to six months of age). The one-button control unit begins a light vibration cycle generated by the SVS platform that sits in the bottom of the baby box. On top of the vibration platform, a safe for infant sleep pad covered by a durable, easy to clean medical grade fabric is placed. Additionally, it comes with a control unit with a UL-approved power supply that can be plugged into a standard electrical outlet.
The gentle, low-level vibration is barely perceptible and does not interfere with an infant’s natural sleep cycles. Besides, since the vibration is random, it is not habit forming, and hence no weaning is required.
The vibration cycles can continue for three hours on one gentle, random vibration setting. The Prapela baby box, on the other hand, folds and pops up in a second and can be easily folded back and fitted into the durable shipping box making it easy to take on trips. The vibration platform and pad fit snugly in the box, taking about a minute to be set up completely. Covered in Sure- Chek™ fabric designed for hospital use, the sleeping pad is flame resistant, durable, and non-penetrable to liquids and body waste, and can be easily cleaned with mild soapsuds with a warm water rinse. To add to that, the Certi-PUR-US foam mattress is a full 1.5 inches thick and is made without flame retardants, formaldehyde, ozone depleters, and phthalates with low VOC emissions.
The Prapela baby box comes with the same features as the Prapela SVS baby box and is an affordable safe sleep environment designed in accordance with hospital standards. The cost-efficient Prapela baby box is just the foldable casing that is SVS compatible and can be supplemented with an SVS platform later on.
Prapela is laser-focused on achieving its goal of producing the first FDA-approved device for NAS treatment. The Prapela team is consistently working to receive FDA clearance for its SVS Hospital Bassinet pad to improve the clinical course of pharmacologically treated newborns diagnosed with NAS. “Our ‘Eureka!’ moment was when we realized that putting our clinically proven (developed at UMass and Harvard) vibration in a baby box instead of a bassinet would be more affordable and useful to our customers, accelerate our time to market, and reduce our development costs,” mentions Konsin.
The company has also applied for an NIH grant and entered the FDA’s Opioid Technology Challenge, bagging a prize amount of $200,000 in the second phase to accelerate the development of its latest product and receive regulatory clearance. The Prapela SVS hospital bassinet pad is well on its way to becoming the first medical device to provide drug-free treatment for NAS babies, wherein one button control unit initiates a vibration cycle produced by a transducer mounted inside the enclosed pad designed to fit the most common sized hospital bassinet. The SVS Hospital Bassinet pad, again, has the same attributes as the one that comes with the Prapela SVS baby box and includes a comfortable fabric to cover the hospital bassinet pad.
A Team Committed to Promoting Wellness
The high-performance team at Prapela is dedicated to verifying the benefits of SVS through science and clinical evaluation, bringing a wealth of knowledge and 75 years of experience in Life Sciences. Realizing that each child is different and has unique needs, the Prapela team pays close attention to supporting product claims with fair and rigorous evaluation. That is not all; the innovation that Prapela brought in the Pediatrics space is the result of ten years of effort in the science, product development, and clinical evaluation of SVS at Harvard’s Wyss Institute for Biologically Inspired Engineering along with the University of Massachusetts Memorial Medical Center and Massachusetts General Hospital.
However, according to Konsin, the most significant barrier for the Prapela team has been convincing health care practitioners and consumers that vibration can be therapeutic for newborns. “Most people think products using vibration are gimmicks, but independent clinical trials have proven our vibration improves cardiorespiratory function and relaxation in opioid-exposed infants. Additionally, another independent study confirmed the technology improves breathing and oxygenation in preemies,” affirms Konsin.
In the upcoming years, Prapela envisions overcoming the hurdle of making people believe in the power of vibrations aimed at enhancing the lives of infants born with NAS. The company plans on conducting more studies, improve word of mouth, and releasing its newest product in the market soon to soothe NAS-affected babies and help them relax and lead a healthier life.
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