Tufts Medical Center and Prapela, an infant health company in Biddeford, ME, have been awarded a joint $2.5 million grant from the National Institute on Drug Abuse through the Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative, to help advance the development of the Prapela SVS Hospital Bassinet for the treatment of newborns diagnosed with Neonatal Abstinence Syndrome (NAS)/Neonatal Opioid Withdrawal Syndrome (NOWS).
In the United States, a baby is diagnosed with NAS every 19 minutes. Newborns with NAS often experience tremors, breathing problems and hyperirritability as they withdraw from opioids they were exposed to during pregnancy. There is no standard treatment for NAS. Hospitals and long-term care organizations are seeking drug-free solutions for initial treatment and soothing babies at home after discharge.
"Studies have demonstrated that an inability to self-regulate plays a key role in the major symptoms of NAS," said Rachana Singh, MD, MS, Associate Chief of Newborn Medicine at Tufts Medical Center. "While non-pharmacologic care methods - rooming-in, skin-to-skin care, gentle rocking and soothing techniques - can make a big difference in short-term outcomes for babies with NAS, it is not always feasible to accomplish consistent delivery of these therapies, due to either lack of parental presence or additional demands on the healthcare team. We are excited about the potential of the Prapela SVS mattress to help mitigate NAS symptoms in neonates and provide relief to caregivers."
Prapela is integrating stochastic vibrotactile stimulation, or SVS, into a hospital bassinet pad. The affordable device fits inside a standard hospital bassinet basket and generates a gentle, random vibration. In a published clinical trial, the SVS pad improved breathing, heart rate and relaxation in opioid-exposed newborns treated in hospitals with morphine.
The grant funds will be directed towards the launch of a randomized clinical trial, aimed at assessing the benefit of the SVS technology in ameliorating NAS symptoms and decreasing the number of babies requiring pharmacotherapy for NAS. Babies participating in the multi-site trial will be enrolled at Tufts Medical Center and its community Level 2 NICU partner hospitals, as well as at UMass Memorial Medical Center.
"Investment in pediatric innovation is so crucial for our children. We are incredibly grateful for this Small Business Innovation Research (SBIR) grant supported by the National Institute on Drug Abuse (NIDA) of the NIH," said John Konsin, Co-founder and CEO of Prapela, Inc. "In addition to providing clinical results, this grant helps us further improve the safety of our bassinet pad. Finally, the research will also be useful to potentially expand claims for the device through the appropriate regulatory processes."
About Prapela, Inc.
Prapela, Inc. is an award-winning start-up focused on the application of SVS technology to improve infant health. Since 2017 the company has been awarded over $4.7M in grants and awards supporting the development of its affordable medical device, the Prapela SVS hospital bassinet. The initial application of the device is to improve the treatment of opioid-exposed infants. Additionally, the same technology has generated positive clinical results in infants suffering from apnea of prematurity. Headquartered in Biddeford, Maine the company is preparing its first application to the FDA for regulatory clearance.
Research reported in this announcement was supported by the National Institute on Drug Abuse through the NIH HEAL Initiative under Award Number 2R44DA049300-02. The content is solely the responsibility of the authors and does not represent the official views of the National Institutes of Health.
