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.

项目概要 该项目提案的长期目标是开发一种疗法并将其商业化，以帮助 患有缺氧缺血性脑损伤 (HIE) 且喂养困难的早产儿和足月儿。 独立喂养对于婴儿出院与家人一起回家并避免 胃造口管（G 管）放置。目前婴儿喂养护理标准 困难涉及早期口腔运动刺激和每天一次与治疗师一起喂养以确保安全 喂养。市场上的技术具有诊断功能，使临床医生能够 监测喂养参数，但没有技术主动改善出院经口喂养。 我们的团队之前发起了一项婴儿首次试点研究，其中我们将经皮配对 耳迷走神经刺激 (taVNS) 通过奶瓶喂养进行刺激以增强运动能力 学习如何喂养无法经口喂养的早产儿或足月 HIE 婴儿。 taVNS 是一种非 迷走神经刺激的侵入形式，促进活动依赖性神经可塑性。 在此试点期间，我们的团队开发了定制的开环和闭环 taVNS 配对喂养 系统来测试初始功效。初步数据显示，27 个国家没有出现明显的不利影响。 接受这种新疗法治疗的患者。此外，50% 的婴儿在两周内实现了完全经口喂养 当他们收到 G 管时。为了进一步的临床试验测试和商业化， 我们需要创建一个更便宜、更紧凑、更易于使用的设置。 在此一期应用中，我们建议开发 BabyStrong taVNS 奶瓶 喂养系统，随后在小规模安全性和有效性研究中进行验证。这 该提案的结果将支持我们的假设，即 taVNS 配对喂养会改善 该弱势群体的每日喂养量使我们能够进行第二阶段随机 对照试验。