Long Term Pulse Oximeter Monitoring for Neonates with Chronic Disease

慢性病新生儿的长期脉搏血氧仪监测

基本信息

批准号：
9324062
负责人：
PAUL L GIBSON
金额：
$ 80.63万
依托单位：
ADVANCED MEDICAL ELECTRONICS CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-08-01 至 2021-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9324062
关键词：
Acute Adult Affect Aftercare Bronchopulmonary Dysplasia California Caring Charge Chronic Chronic Disease Chronic lung disease Clinic Collaborations Comparative Study Complex Consult Data Development Devices Disease Electrical Engineering Electronics Engineering Ensure Equipment Evaluation Eye FDA approved Future Gold Heart Rate Home environment Hospitalization Human Hypoxia Infant Infant Care Laboratories Lasers Light Lung Lung diseases Manufacturer Name Mechanics Medical Medical Device Mind Monitor Morbidity - disease rate Motion Neonatal Neonatal Intensive Care Units Newborn Infant Optics Output Performance Perfusion Perinatal Care Phase Physiologic pulse Premature Birth Premature Infant Preparation Principal Investigator Production Pulse Oximetry Radio Recording of previous events Research Respiration Disorders Safety San Francisco Software Engineering Source Surface System Technology Testing Time Tissues United States United States National Institutes of Health Universities Untrained Personnel Weight Wireless Technology Work base design ergonomics experience health care economics in vivo infancy instrumentation neonatal care neonate new technology next generation performance tests preterm newborn product development programs prototype public health relevance respiratory distress syndrome safety testing sensor simulation success surfactant deficiency

Acute Adult Affect Aftercare Bronchopulmonary Dysplasia California Caring Charge Chronic Chronic Disease Chronic lung disease Clinic Collaborations Comparative Study Complex Consult Data Development Devices Disease Electrical Engineering Electronics Engineering Ensure Equipment Evaluation Eye FDA approved Future Gold Heart Rate Home environment Hospitalization Human Hypoxia Infant Infant Care Laboratories Lasers Light Lung Lung diseases Manufacturer Name Mechanics Medical Medical Device Mind Monitor Morbidity - disease rate Motion Neonatal Neonatal Intensive Care Units Newborn Infant Optics Output Performance Perfusion Perinatal Care Phase Physiologic pulse Premature Birth Premature Infant Preparation Principal Investigator Production Pulse Oximetry Radio Recording of previous events Research Respiration Disorders Safety San Francisco Software Engineering Source Surface System Technology Testing Time Tissues United States United States National Institutes of Health Universities Untrained Personnel Weight Wireless Technology Work base design ergonomics experience health care economics in vivo infancy instrumentation neonatal care neonate new technology next generation performance tests preterm newborn product development programs prototype public health relevance respiratory distress syndrome safety testing sensor simulation success surfactant deficiency

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项目摘要

DESCRIPTION (provided by applicant): This project aims to develop continuous pulse oximetry monitoring technology to facilitate the care of infants after they have transitioned from the neonatal intensive care unit (NICU) to home. This technology targets the monitoring of neonates with chronic lung disease of infancy (CLDI), a group of respiratory diseases that usually evolves from an acute respiratory disorder experienced by a newborn infant. Advances in perinatal care, changes in health care economics, and research suggesting a negative impact of prolonged hospitalization on development of the preterm newborn have influenced discharge practices for infants with CLDI. The home environment has increasingly been recognized as the optimal setting for medically stable, technology assisted infants to receive the complex and demanding care they require. Infants in the NICU are commonly connected to multiple pieces of equipment and monitors. While this lifesaving technology is a necessary part of providing care to these infants, the many wires can also add to the complexity of caring for these infants, particularly in a home environment with untrained personnel. Very recent advances in electronic components allow miniature wireless medical instrumentation to be developed that is of a size and weight appropriate for a long-term wearable neonate application. This project includes a unique team of medical device experts with a history of FDA approved products, research neonatologists, pulse oximetry design experts, and a human factors expert. Testing will include FDA recommended 510(K) safety and performance evaluations, a desaturation study, and a gold standard comparison evaluation in neonates.

描述（由适用提供）：该项目旨在开发连续的脉搏血氧仪监测技术，以促进婴儿从新生儿重症监护病房（NICU）过渡到家庭后的护理。该技术针对的是儿童慢性肺病（CLDI）的新生儿，这是一组呼吸道疾病，通常是从新生婴儿经历的急性呼吸系统疾病演变而来的。围产期护理的进步，医疗保健经济学的变化以及研究表明，长期住院对早产新生儿发展的负面影响影响了CLDI婴儿的出院实践。家庭环境已被认为是医学稳定的技术辅助婴儿获得所需的复杂和苛刻护理的最佳环境。 NICU中的婴儿通常与多个设备和监视器连接。尽管这种救生技术是为这些婴儿提供护理的必要部分，但许多电线也可以增加照顾这些婴儿的复杂性，尤其是在没有受过训练的人员的家庭环境中。电子组件的最新进展允许开发微型无线医疗仪器，其尺寸和重量适合长期可穿戴的新生儿应用。该项目包括一个独特的医疗设备专家团队，拥有FDA批准的产品，研究新生儿学家，脉搏血氧仪设计专家以及人为因素专家的历史。测试将包括FDA建议的510（k）安全性和绩效评估，讨论研究以及新生儿的黄金标准比较评估。