Long Term Pulse Oximeter Monitoring for Neonates with Chronic Disease

 描述（由申请人提供）：本项目旨在开发连续脉搏血氧监测技术，以促进婴儿从新生儿重症监护室（NICU）过渡到家中后的护理。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。围产期护理的进展，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育的负面影响，影响了CLDI婴儿的出院实践。家庭环境越来越被认为是医学上稳定的、技术辅助的婴儿接受他们所需的复杂和苛刻护理的最佳环境。NICU中的婴儿通常连接到多个设备和监视器。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，特别是在没有受过训练的人员的家庭环境中。电子元件的最新进展允许开发微型无线医疗仪器，其具有适合于长期可穿戴新生儿应用的尺寸和重量。该项目包括一个独特的医疗器械专家团队，该团队具有FDA批准产品的历史，研究医学家，脉搏血氧仪设计专家和人为因素专家。测试将包括FDA推荐的510（K）安全性和性能评价、去饱和研究和新生儿金标准比较评价。

 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.