BabyStrong taVNS-Paired BottleFeeding to Improve Oral Feeding

BabyStrong taVNS 配对奶瓶喂养可改善经口喂养

• 批准号: 10258359
• 负责人: DOROTHEA DENISE JENKINS
• 金额: $ 31.87万
• 依托单位: FRD ACCEL, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-07 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10258359
• 关键词: Abnormal coordination; Adult; Adverse effects; Behavior Therapy; Blinded; Bottle feeding; Bradycardia; Brain Injuries; Cerebral Palsy; Clinical; Clinical Data; Clinical Treatment; Clinical Trials; Complex; Crossover Design; Custom; Data; Deglutition; Development; Developmental Delay Disorders; Devices; Diagnostic; Diffusion Magnetic Resonance Imaging; Ear; Electric Stimulation; Electrodes; Failure; Family; Feedback; Feeds; GTP-Binding Protein alpha Subunits, Gs; Gastrostomy; Goals; Heart Rate; Home; Hospital Costs; Hospitalization; Hypoxic-Ischemic Brain Injury; Infant; Infant Care; Intervention; Learning; Length of Stay; Manufacturer Name; Measures; Medical; Mentors; Monitor; Motor; Multicenter Neonatal Research Network; Neurodevelopmental Disorder; Neuronal Plasticity; Nurses; Oral; Oral cavity; Outcome; Pain; Parents; Patients; Phase; Physiologic pulse; Pilot Projects; Population; Positioning Attribute; Pregnancy; Premature Infant; Randomized Controlled Trials; Reproducibility; Risk; Safety; Sensory; South Carolina; Stress Tests; System; Technology; Testing; Time; Tube; Universities; Validation; Vulnerable Populations; Wireless Technology; active method; analog; base; care providers; commercialization; computerized; cost; design; efficacy study; feeding; high risk; improved; motor learning; neuroregulation; novel; novel therapeutics; nutrition; pilot trial; portability; post stroke; programs; prototype; safety study; standard of care; success; sucking; translational scientist; treatment duration; treatment planning; vagus nerve stimulation; volunteer; white matter

Project Summary The long-term goal of this project proposal is to develop and commercialize a therapy to assist pre-term, and term infants with hypoxic ischemic brain injury (HIE), with feeding difficulty. Independent feeding is critical for infants to be discharged home with their families and avoid a gastrostomy tube (G-tube) placement. The current standard of care for infants with feeding difficulty involves early oromotor stimulation and feeding with therapists once daily for safe feeding. Technologies on the market possess diagnostic capabilities that allow clinicians to monitor feeding parameters, but no technologies actively improve oral feeding for discharge. Our team previously initiated a first-in-infants pilot study in which we paired transcutaneous auricular vagus nerve stimulation (taVNS) stimulation with bottle feeding to enhance motor learning of feeding in preterm or term HIE infants, who were failing oral feeds. taVNS is a non- invasive form of vagus nerve stimulation, which facilitates activity-dependent neuroplasticity. During this pilot trial, our team developed custom open and closed-loop taVNS-paired feeding systems to test initial efficacy. Preliminary data shows no significant adverse effects in the 27 patients treated with this novel therapy. Also 50% of infants achieved full oral feeds in 2 weeks when they would have received a G-tube. For further clinical trial testing and commercialization, we need to create a less expensive and compact set-up that is easier to use. In this Phase I application, we propose the development of our BabyStrong taVNS bottle feeding system, with subsequent validation in a small-scale safety and efficacy study. The findings from this proposal will support our hypothesis that taVNS paired feedings will improve daily feeding volumes for this vulnerable population and position us for a phase II randomized controlled trial.

项目摘要 该项目提案的长期目标是开发和商业化一种治疗方法， 患有缺氧缺血性脑损伤（HIE）的早产儿和足月儿，伴有喂养困难。 独立喂养对于婴儿出院回家与家人一起并避免 胃造口管（G管）放置。目前喂养婴儿的护理标准 困难包括早期的orbital刺激和喂养与治疗师每天一次，以确保安全 喂食市场上的技术具有诊断能力，使临床医生能够 监测喂养参数，但没有技术积极改善出院时的口服喂养。 我们的团队先前启动了一项首次在婴儿中进行的试点研究， 耳迷走神经刺激（taVNS）刺激与奶瓶喂养，以增强运动 在经口喂养失败的早产或足月HIE婴儿中学习喂养。tavns是一个非- 迷走神经刺激的侵入性形式，其促进活动依赖性神经可塑性。 在这个试点试验中，我们的团队开发了定制的开放和闭环taVNS配对喂养， 测试初始功效的系统。初步数据显示，在27个 接受这种新疗法治疗的患者。另外，50%的婴儿在2周内实现了完全口服喂养 而他们本可以接受G管为了进一步的临床试验测试和商业化， 我们需要创造一种更便宜、更紧凑、更容易使用的装置。 在第一阶段的申请中，我们建议开发BabyStrong tavNS瓶 喂养系统，随后在小规模安全性和有效性研究中进行验证。的 这项提议的发现将支持我们的假设，即taVNS配对喂养将改善 每日喂养量为这个脆弱的群体，并定位我们的第二阶段随机 对照试验