BabyStrong taVNS-Paired BottleFeeding to Improve Oral Feeding

项目摘要 该项目提案的长期目标是开发一种治疗方法并将其商业化 早产儿和足月儿患有缺氧缺血性脑损伤(HIE)，喂养困难。 独立喂养对于婴儿与家人一起出院并避免 胃造瘘管(G管)放置。目前对喂养婴儿的护理标准 困难包括早期口腔运动刺激和为安全起见每天与治疗师一起喂养一次 喂食。市场上的技术具有诊断能力，使临床医生能够 监控喂食参数，但没有技术积极改善口腔喂食以排出。 我们的团队之前启动了一项婴儿首例先导性研究，在该研究中，我们通过经皮途径配对 奶瓶喂养刺激耳迷走神经以增强运动能力 口服喂养失败的早产儿或足月儿的喂养学习。TaVNS是一种非 侵入性迷走神经刺激，有助于活动依赖的神经可塑性。 在这项试点试验中，我们的团队开发了定制的开环和闭环taVNS配对喂养 用于测试初始效果的系统。初步数据显示，在27个国家中没有明显的不良影响 接受这种新疗法治疗的患者。另外，50%的婴儿在两周内完成了充分的口服喂养 当他们收到G管的时候。为了进一步的临床试验测试和商业化， 我们需要创建一种更便宜、更紧凑、更易于使用的设置。 在这个第一阶段的应用中，我们建议开发我们的BabyStrong taVNS瓶 饲喂系统，随后在小规模安全性和有效性研究中进行验证。这个 这项提案的发现将支持我们的假设，即taVNS配对喂养将有所改善 这一脆弱人群的每日喂食量，并使我们进入第二阶段随机 对照试验。

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.