Transcutaneous auricular neurostimulation for neonatal abstinence syndrome

Spark Biomedical Inc, Friendswood TX

Investigators

Linked publications & trials

Abstract

Neonatal abstinence syndrome (NAS) is a condition in which infants undergo withdrawal after exposure to prescription or non-prescription opioids such as methadone or heroin in utero. NAS babies exhibit hyperirritability of the central nervous system and respiratory, gastrointestinal, and autonomic symptoms. These symptoms usually appear within 48 to 72 hours after birth. As of 2012, an infant with NAS was born every 25 minutes in the US, accounting for more than $1.5 billion in national healthcare expenditures. Between 2000?2012, national rates of NAS increased 383% from 1.2 per 1000 births to 5.8 per 1000 births. These infants frequently require hospital stay in a neonatal intensive care unit (NICU) with an average hospital stay of 25 days at an average treatment cost of $66K. Currently, no nationwide standard of care exists for managing NAS. Treatment of NAS usually follows a multimodal regime based on drug therapy with an oral morphine solution, mostly in combination with a sedative. This approach is clearly controversial as it can impart additional stress on the newborn, thus the need for a sedative. The American Academy of Pediatrics recommends attempting the use of non-pharmacologic treatment, which includes placing the infant in a dark and quiet environment, swaddling, rocking, breastfeeding, and providing high-calorie nutrition in frequent small feedings, among other techniques. When utilized appropriately, such non-pharmacological interventions have resulted in a reduction in length of stay, length of treatment, and percentage of infants requiring pharmacotherapy. Auricular acupuncture has recently been studids as an adjunctive therapy for NAS newborns. The use of non- insertive acupuncture (NIA) using traditional needles or a handheld laser has resulted in some of NAS babies becoming more relaxed during their course of treatment. While more indepth studies are needed to evaluate NIA as an effective adjunct therapy for NAS newborns, the early results show promise of tapping into the auricular neural pathways for treating NAS. While acupuncture is quite safe and requires no specialized equipment, the results of the technique can vary widely depending on who is applying the therapy. We propose to develop a transcutaneous auricular neurostimulation device to help NAS babies recover from opioid withdrawal without harmful side effects. The non-invasive, auricular neurostimulation device will be placed around the ear (similar to a hearing aid) and stimulation will be delivered transcutaneously.