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

基本信息

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
项目类别：
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

项目摘要

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改善高风险婴儿护理，从医院到家Neoneur 远程医疗（4.21）高风险婴儿的总体结果已显着改善到decadess 随着长期生存和较少的主要病情。根据生存质量的结果，神经发育障碍是一种早产和主要先天性异常的标志。对高风险婴儿的护理挑战，许多人从喂养管开始生活喂食是延迟排放的最常见原因。对早产儿以及出生的患有复杂先天性疾病的挑战，许多与其他人不同，他们是通过鼻胃管喂养的关键的生理参数当前是测量足够的定量手段婴儿成熟（对于早产儿）或恢复（对于心脏婴儿），以安全地过渡到没有呼吸风险的口服喂养。（已发行专利8473219，8413502）衡量口腔供应模式，同步呼吸为临床医生提供了对进食模式的定量评估 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）。是生物标志物，可以改善护理和过渡到口服喂养，并通过远程医疗评估更聪明，减少了重新搬迁的必要性由于体重不佳。 Neoneur提供以下功能：临床环境中的实用程序，一种用于远程远程医疗评估，证明与婴儿特异性的临床相关性相关测量和跟踪，改善FDA的应用和索赔，提前采用市场，和投资者准备。通过以下目的相关设备。临床清洁线和远程医疗功能：第二阶段 - 规模制造和执行评估安全性和临床价值/实用程序的研究。患有复杂先天性心脏病的婴儿，并从口服喂养开始医院并继续在家中最多12周。