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.

新生儿戒断综合征 (NAS) 是一种婴儿在接触 子宫内服用处方或非处方阿片类药物，例如美沙酮或海洛因。 NAS 婴儿表现出过度烦躁 中枢神经系统以及呼吸系统、胃肠道和自主神经症状。这些症状 通常出现在出生后 48 至 72 小时内。截至 2012 年，每 25 分钟就有一名患有 NAS 的婴儿出生 美国的国家医疗保健支出超过 15 亿美元。 2000年至2012年间，全国 NAS 发生率从每 1000 名新生儿 1.2 例增加到每 1000 名新生儿 5.8 例，增加了 383%。这些婴儿经常需要 新生儿重症监护病房 (NICU) 住院时间 平均住院时间为 25 天 治疗费用为 66K 美元。 目前，尚无管理 NAS 的全国性护理标准。 NAS 的治疗通常遵循 基于口服吗啡溶液药物治疗的多模式治疗方案，大多与镇静剂联合使用。 这种方法显然是有争议的，因为它会给新生儿带来额外的压力，因此需要 镇静剂。美国儿科学会建议尝试使用非药物治疗 治疗，包括将婴儿置于黑暗和安静的环境中、襁褓、摇晃、母乳喂养、 除其他技术外，还通过频繁的少量喂食提供高热量营养。使用时 适当地，此类非药物干预措施已导致住院时间、住院时间的缩短。 治疗以及需要药物治疗的婴儿的百分比。 耳针疗法最近被研究为 NAS 新生儿的辅助疗法。使用非 使用传统针或手持式激光的插入针灸 (NIA) 已导致一些 NAS 婴儿 在治疗过程中变得更加放松。虽然需要更深入的研究来评估 NIA 作为 NAS 新生儿的有效辅助疗法，早期结果显示了利用耳廓进行治疗的前景 治疗 NAS 的神经通路。 虽然针灸非常安全并且不需要专门的设备，但该技术的结果可能会有所不同 很大程度上取决于谁正在应用该疗法。我们建议开发一种经皮耳廓 神经刺激装置可帮助 NAS 婴儿从阿片类药物戒断中恢复，且不会产生有害副作用。这 非侵入性耳廓神经刺激装置将放置在耳朵周围（类似于助听器），并且 刺激将经皮传递。