Improving high-risk infant care: from Hospital to Home with Neoneur Telehealth

摘要 Neoneur 921494改善高危婴儿护理，从医院到家与Neoneur 远程保健（4.21） 在过去的二十年里，高危婴儿的总体结局有了显著改善 长期生存率增加，主要发病率降低。重点已经转移到定义 根据生存质量的结果，神经发育障碍是其中之一 早产和严重先天性畸形的特征喂养仍然是一个主要的 高风险婴儿的护理面临挑战，许多婴儿是通过喂食管开始生命的。贫困 进食是延迟出院的最常见原因。安全的口服喂养是一个特殊的 对于早产儿和那些出生时患有复杂先天性疾病的人来说， 这些患者在手术后最初或恢复期间通过鼻胃管进食。不像其他 关键生理参数目前没有定量手段来测量足够的 婴儿成熟（对于早产儿）或恢复（对于心脏病婴儿），以安全过渡到 经口进食，无呼吸道风险。Neoneur是一款手持式移动终端， （授权专利8473219，8413502）测量口腔压力的模式，同步 呼吸为临床医生提供了对喂养模式的定量评估。在 2019年，Neoneur，LLC作为国家I-Corps的一部分完成了150多个临床面试 程序（NSF 1844816）。基于这些访谈，我们假设Neoneur的测量结果 是生物标志物，将提高护理质量和过渡到口服喂养， 远程健康评估婴儿将更早回家，减少再次住院的必要性 因为体重增加太少该提案支持的技术努力将推动 Neoneur提供以下功能的能力：在临床环境中的实用性， 远程医疗评估，证明了与婴儿特定临床相关性的相关性 测量和跟踪，改进FDA申请和声明，推进市场采用， 投资者的准备。这个快速通道SBIR建议将研究转化为临床研究。 相关设备通过以下目的。第一阶段-为可制造性升级原型，- 临床清洁度和远程医疗功能：第二阶段-规模生产和执行 评估安全性和临床价值/效用的研究。我们将招募140名早产儿， 患有复杂先天性心脏病的婴儿，并从开始口服喂养开始对其进行随访， 住院并在家中继续最多12周。

Summary Abstract Neoneur 921494 Improving High-Risk Infant care, From Hospital to Home with Neoneur Telehealth (4.21) The overall outcome for high-risk infants have improved significantly over the past two decades with increased long-term survival and less major morbidities. The focus has shifted to defining outcomes according to the quality of survival, with neurodevelopmental impairments being one of the hallmarks of both prematurity and major congenital anomalies. Feeding remains a major challenge for nursing care of high-risk infants, many who start life with a feeding tube. Poor feeding is the most common reason for delayed discharge. Safe oral feeding is a particular challenge for premature infants, and those born with complex congenital disorders, many of whom are fed via a nasogastric tube initially or during recovery after surgery. Unlike other critical physiological parameters currently there is no quantitative means to measure adequate infant maturation (for the preterm infant) or recovery (for the cardiac infant) to safely transition to oral feeding without respiratory risk. The Neoneur is a hand-held, mobile device, which uniquely (issued patents 8473219, 8413502) measures patterns of oral cavity pressure, synchronized with respiration providing the clinician with a quantitative assessment of feeding patterns. In 2019, Neoneur, LLC completed over 150 clinical interviews as part of the national I-Corps program (NSF 1844816). Based on these interviews we hypothesize Neoneur’s measurements are biomarkers that will improve quality of care and transitions to oral feeding, and by enabling telehealth evaluation infants will get home earlier and decreases necessity for rehospitalization due to poor weight gain. The technical effort supported by this proposal will advance the capability of the Neoneur to provide the following: utility in the clinical setting, a means for remote telehealth evaluations, demonstrated correlation to clinical relevance in infant specific measurements and tracking, improve FDA application and claims, advance market adoption, and investor readiness. This Fast-Track SBIR proposes to transform a research into a clinically relevant device through the following aims. Phase l -upgrade prototype for manufacturability, - clinical cleanliness, and telehealth functionality: Phase II - scale manufacturing, and performing a study to assess safety and clinical value/utility. We will enroll 140 preterm infants and 140 infants with complex congenital heart disease and follow them from initiation of oral feeding in the hospital and continue in the home for a maximum total of 12 weeks.