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

改善高危婴儿护理：通过 Neoneur Telehealth 从医院到家庭

• 批准号: 10701053
• 负责人: Caroline Hoedemaker
• 金额: $ 75.62万
• 依托单位: NEONEUR LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-03 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10701053
• 关键词: Academy; Adoption; American; Assessment tool; Award; Biological Markers; Cardiac; Care given by nurses; Child; Childhood; Clinical; Clinical Nursing; Clinical Trials; Complex; Congenital Disorders; Data; Data Correlations; Decision Making; Deglutition; Development; Devices; Documentation; Enrollment; Enteral Feeding; Evaluation; Feedback; Feeding Patterns; Feeding behaviors; Functional disorder; Funding; Gestational Age; Goals; Good Manufacturing Process; Grant; Heart Abnormalities; Home; Hospitals; Impairment; Infant; Infant Care; Infection Control; Innovation Corps; Intervention; Interview; Legal patent; Licensing; Life; Link; Marketing; Measurement; Measures; Modality; Monitor; Morbidity - disease rate; Neurodevelopmental Impairment; Nipples; Nutrient; Operative Surgical Procedures; Opioid; Oral; Oral cavity; Outcome; Parents; Patients; Pattern; Pediatrics; Pennsylvania; Performance; Phase; Physiological; Premature Infant; Process; Production; Publications; Quality of Care; Readiness; Recovery; Research; Respiration; Risk; Safety; Small Business Innovation Research Grant; Surveys; Testing; Tube; Universities; Weight Gain; Work; clinical decision-making; clinically relevant; commercialization; congenital anomaly; congenital heart disorder; data warehouse; design; feeding; feeding schedule; handheld mobile device; health communication; high risk infant; hospital readmission; improved; improved outcome; individual patient; innovation; interest; iterative design; manufacturability; manufacture; population based; postoperative recovery; premature; pressure; programs; prototype; respiratory; safety assessment; skills; success; sucking; telehealth; tool; usability; wireless communication

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.

摘要摘要 Neoneur 921494改善高危婴儿护理，从医院到新生儿家庭 远程医疗(4.21) 在过去的二十年里，高危婴儿的总体结局有了显著的改善。 随着长期存活率的提高和重大疾病的减少。焦点已经转移到定义 根据生存质量的结果，神经发育障碍是其中之一 早产儿和重大先天畸形的特征。喂食仍然是主要的 高危婴儿的护理面临挑战，许多婴儿从喂养管开始生命。穷 喂食是延迟放电的最常见原因。安全的口服喂养是一种特殊的 对于早产儿和那些出生时患有复杂先天性疾病的人来说，许多 他们最初或在手术后恢复期间通过鼻胃管喂养。不同于其他 关键生理参数目前还没有足够的定量手段来测量 婴儿成熟(对于早产儿)或恢复(对于心脏婴儿)以安全过渡到 无呼吸危险的口服喂养。Neoneur是一款手持移动设备，它独一无二 (专利8473219、8413502)同步测量口腔压力模式 呼吸为临床医生提供了对喂养模式的定量评估。在……里面 2019年，Neoneur，LLC完成了150多次临床访谈，作为国家i-Corps的一部分 计划(国家科学基金1844816)。根据这些采访，我们假设Neoneur的测量 是生物标志物，将改善护理质量和向口服喂养的过渡，并通过使 远程健康评估婴儿将更早回家，并减少再次住院的必要性 由于体重增加不佳。这项提案所支持的技术努力将推动 神经科医生提供以下服务的能力：在临床环境中的效用，一种 远程远程医疗评估，显示与特定婴儿的临床相关性 测量和跟踪，改进FDA申请和声明，促进市场采用， 以及投资者的准备情况。这项快速跟踪SBIR建议将研究转化为临床 相关装置通过以下几个目的。L阶段-升级可制造性原型，- 临床清洁度和远程医疗功能：第二阶段-规模化制造和执行 一项评估安全性和临床价值/效用的研究。我们将招收140名早产儿和140名 婴幼儿复杂性先天性心脏病从开始口服喂养开始 在医院和继续在家中总共最多12周。