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: 10383553
• 负责人: Caroline Hoedemaker
• 金额: $ 25.66万
• 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 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10383553
• 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; Decision Making; Deglutition; Development; Devices; Documentation; Enrollment; Enteral Feeding; Evaluation; Feedback; Feeding Patterns; Feeding behaviors; Foundations; Functional disorder; Funding; Gestational Age; Goals; Grant; Hand; Heart Abnormalities; Home; Hospitals; Impairment; Infant; Infant Care; Infection Control; Innovation Corps; Intervention; Interview; Legal patent; Life; Link; 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; base; clinical decision-making; clinically relevant; congenital anomaly; congenital heart disorder; data warehouse; design; feeding; feeding schedule; handheld mobile device; high risk infant; hospital readmission; improved; improved outcome; individual patient; innovation; interest; iterative design; manufacturability; population based; postoperative recovery; premature; pressure; programs; prototype; respiratory; 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 通过 Neoneur 改善从医院到家庭的高危婴儿护理 远程医疗 (4.21) 过去二十年来，高危婴儿的总体结局已显着改善 随着长期生存率的提高和主要发病率的降低，重点已转移到定义上。 结果取决于生存质量，神经发育障碍是其中之一 早产和严重先天性喂养异常的特征仍然是一个主要特征。 高危婴儿的护理面临着挑战，许多婴儿都是通过饲管开始生活的。 喂养是延迟出院的最常见原因，安全口服喂养是一个特殊的原因。 对于早产儿和出生时患有复杂先天性疾病的婴儿来说，许多 与其他人不同，他们最初或在手术后恢复期间通过鼻胃管进食。 关键的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（对于心脏病婴儿）以安全过渡到 Neoneur 是一款手持式移动设备，具有独特的特点。 （已颁发专利 8473219、8413502）同步测量口腔压力模式 呼吸为临床医生提供了喂养模式的定量评估。 2019 年，Neoneur, LLC 作为国家 I-Corps 的一部分完成了 150 多次临床访谈 计划（NSF 1844816）根据这些采访，我们解决了 Neoneur 的测量问题。 是生物标志物，将提高护理质量和向口服喂养的过渡，并通过使 远程医疗评估婴儿将更早回家并减少再住院的必要性 由于体重增加不佳，该提案支持的技术努力将推进 Neoneur 提供以下功能的能力：在临床环境中的实用性、一种手段 远程远程医疗评估，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，促进市场采用， 该快速通道 SBIR 提议将研究转化为临床研究。 相关设备通过以下目标进行升级原型，- 临床清洁度和远程医疗功能：第二阶段 - 规模制造和执行 一项评估安全性和临床价值/效用的研究我们将招募 140 名早产儿和 140 名。 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跟踪 住院并继续在家中停留最多 12 周。