SPARK BIOMEDICAL INC. — Department of Health and Human Services SBIR Phase I: R43

Description

Neonatal abstinence syndromeNASis a condition in which infants undergo withdrawal after exposure to prescription or non prescription opioids such as methadone or heroin in uteroNAS babies exhibit hyperirritability of the central nervous system and respiratorygastrointestinaland autonomic symptomsThese symptoms usually appear withintohours after birthAs ofan infant with NAS was born everyminutes in the USaccounting for more than $billion in national healthcare expendituresBetweennational rates of NAS increasedfromperbirths toperbirthsThese infants frequently require hospital stay in a neonatal intensive care unitNICUwith an average hospital stay ofdays at an average treatment cost of $KCurrentlyno nationwide standard of care exists for managing NASTreatment of NAS usually follows a multimodal regime based on drug therapy with an oral morphine solutionmostly in combination with a sedativeThis approach is clearly controversial as it can impart additional stress on the newbornthus the need for a sedativeThe American Academy of Pediatrics recommends attempting the use of non pharmacologic treatmentwhich includes placing the infant in a dark and quiet environmentswaddlingrockingbreastfeedingand providing high calorie nutrition in frequent small feedingsamong other techniquesWhen utilized appropriatelysuch non pharmacological interventions have resulted in a reduction in length of staylength of treatmentand percentage of infants requiring pharmacotherapyAuricular acupuncture has recently been studids as an adjunctive therapy for NAS newbornsThe use of noninsertive acupunctureNIAusing traditional needles or a handheld laser has resulted in some of NAS babies becoming more relaxed during their course of treatmentWhile more indepth studies are needed to evaluate NIA as an effective adjunct therapy for NAS newbornsthe early results show promise of tapping into the auricular neural pathways for treating NASWhile acupuncture is quite safe and requires no specialized equipmentthe results of the technique can vary widely depending on who is applying the therapyWe propose to develop a transcutaneous auricular neurostimulation device to help NAS babies recover from opioid withdrawal without harmful side effectsThe non invasiveauricular neurostimulation device will be placed around the earsimilar to a hearing aidand stimulation will be delivered transcutaneously Neonatal abstinence syndromeNASis a condition in which infants undergo withdrawal after exposure to opioids such as methadone or heroin in uteroThe current gold standard solution uses oral morphine and methadone which leads to many unwanted and harmful side effects to the infantWe propose a nonpharmacological treatment to help NAS babies recover from opioid withdrawal without harmful side effects