Transcutaneous auricular neurostimulation for neonatal abstinence syndrome

经皮耳部神经刺激治疗新生儿戒断综合征

• 批准号: 9910282
• 负责人: DOROTHEA DENISE JENKINS
• 金额: $ 21.77万
• 依托单位: SPARK BIOMEDICAL INC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2021-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9910282
• 关键词: Academy; Accounting; Acupuncture Therapy; Adult; Adverse event; Amendment; American; Birth; Bradycardia; Breast Feeding; Burn injury; Calories; Clinical; Clonidine; Convulsions; Crying; Deglutition; Devices; Ear; Ear Acupuncture; Environment; Equipment; Exhibits; Exposure to; Feces; Gold; Health Expenditures; Hearing Aids; Heart Rate; Heroin; Hour; Hydrogels; Infant; Institutional Review Boards; Intervention; Lasers; Length; Length of Stay; Measures; Medical; Medical Device; Medicine; Methadone; Monitor; Morphine; Muscle Tonus; Needles; Neonatal; Neonatal Abstinence Syndrome; Neonatal Intensive Care Units; Nerve; Neural Pathways; Neuraxis; Newborn Infant; Opioid; Oral; Pain; Patients; Pediatrics; Pharmaceutical Preparations; Pharmacotherapy; Phenobarbital; Protocols documentation; Respiratory Signs and Symptoms; Risk; Sensory Thresholds; South Carolina; Stress; Symptoms; Techniques; Technology; Therapeutic; Treatment Cost; Treatment Protocols; Tremor; Trigeminal System; Universities; Vomiting; Withdrawal; Withdrawal Symptom; base; experience; feeding; gastrointestinal; gastrointestinal symptom; improved; in utero; morphine administration; multimodality; neonate; nutrition; open label; opioid withdrawal; prospective; recruit; respiratory; safety and feasibility; sedative; side effect; skin irritation; standard of care; sucking; treatment duration; vagus nerve stimulation

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.

新生儿禁欲综合征（NAS）是一种基础设施在暴露后撤离的条件 处方或非处方阿片类药物，例如子宫内的Metagadone或海洛因。 NAS婴儿表现出高度润湿性 中枢神经系统和呼吸道，胃肠道和自主符号的符号。这些符号 通常在出生后48至72小时内出现。截至2012年，有NAS的婴儿每25分钟出生 美国，占国家医疗保健支出超过15亿美元。在2000 - 2012年之间，国家 NAS的率从每1000个出生的1.2增加到每1000个出生的5.8个增长率383％。这些婴儿经常需要 医院住在新生儿重症监护病房（NICU），平均住院时间为25天 治疗费用为$ 66K。 目前，管理NAS尚无全国护理标准。 NAS的治疗通常遵循 基于口服吗啡溶液的药物治疗基于药物治疗的多模式状态，主要与镇静剂结合使用。 这种方法显然引起了争议，因为它可以给新生儿带来更多的压力，因此需要 镇静剂。美国儿科学会建议尝试使用非药物 治疗，其中包括将婴儿置于黑暗而安静的环境中，摇摆，摇摆，母乳喂养， 并提供高热量的营养，以及其他技术，以及其他技术。使用时 适当地，这种非药理学干预措施导致住院长度降低 治疗和需要药物治疗的婴儿的百分比。 耳针针灸最近是NAS新生儿的辅助疗法。使用非 使用传统针或手持激光器的插入针灸（NIA）导致了一些NAS婴儿 在治疗过程中变得更加放松。虽然需要更多的深入研究来评估NIA 作为NAS新生儿的有效辅助疗法，早期结果表明有望攻入耳 治疗NAS的神经途径。 虽然针灸非常安全，并且不需要专业设备，但该技术的结果可能会有所不同 广泛取决于谁正在应用治疗。我们建议开发经皮的耳胶质 神经刺激装置可帮助NAS婴儿从阿片类药物戒断中恢复而没有有害的副作用。这 无创，耳神经刺激装置将放置在耳朵周围（类似于助听器）和 刺激将经常传递。