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

• 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
• 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

 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（由申请人提供）：该项目旨在开发连续脉搏血氧饱和度监测技术，以方便婴儿从新生儿重症监护病房（NICU）过渡到家庭后的护理。该技术的目标是监测患有婴儿慢性肺病 (CLDI) 的新生儿，这是一组呼吸系统疾病，通常由新生儿经历的急性呼吸系统疾病演变而来。围产期护理的进步、医疗保健经济学的变化以及表明长期住院对早产儿发育产生负面影响的研究都影响了 CLDI 婴儿的出院做法。家庭环境越来越被认为是医疗稳定、技术辅助的婴儿接受他们所需的复杂而苛刻的护理的最佳环境。新生儿重症监护病房 (NICU) 中的婴儿通常连接到多台设备和监视器。虽然这种救生技术是为这些婴儿提供护理的必要组成部分，但许多电线也会增加护理这些婴儿的复杂性，特别是在人员未经培训的家庭环境中。电子元件的最新进展使得微型无线医疗仪器得以开发，其尺寸和重量适合长期可穿戴新生儿应用。该项目包括一支独特的团队，由具有 FDA 批准产品历史的医疗器械专家、新生儿研究专家、脉搏血氧仪设计专家和人为因素专家组成。测试将包括 FDA 推荐的 510(K) 安全性和性能评估、去饱和研究以及新生儿金标准比较评估。