The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals

TELENEO 试验：在社区医院进行高级新生儿复苏远程医疗的多中心试验

• 批准号: 10712707
• 负责人: Bart M Demaerschalk
• 金额: $ 74.12万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10712707
• 关键词: Address; Birth; Birth Weight; Brain Injuries; Brain imaging; Breathing; Cardiopulmonary Resuscitation; Caring; Cessation of life; Chest; Clinical Trials; Community Hospitals; Consult; Continuous Positive Airway Pressure; Critical Illness; Data; Delivery Rooms; Development; Distant; Effectiveness; Electroencephalography; Eligibility Determination; Emergency Situation; Epinephrine; Equity; Family; Future; Goals; Health; Health Services Accessibility; Hospitals; Inequity; Intervention; Intervention Studies; Knowledge; Life; Location; Measures; Mission; Modeling; Morbidity - disease rate; Multicenter Trials; National Institute of Child Health and Human Development; Neonatal Intensive Care Units; Neonatal Mortality; Newborn Infant; Outcome; Oxygen; Patients; Pilot Projects; Pneumothorax; Population; Public Health; Randomized; Readiness; Research; Resuscitation; Risk; Risk Reduction; Seizures; Service delivery model; Site; Telemedicine; Telephone; Testing; Therapeutic; Time; Very Low Birth Weight Infant; Visualization; care delivery; design; disability; evidence base; experience; fetal; health care delivery; health disparity; hospital care; improved; improved outcome; innovation; intraventricular hemorrhage; mortality; mortality risk; natural hypothermia; neonatal care; neonatal health; neonatal morbidity; neonatal resuscitation; neonate; outcome disparities; poor health outcome; premature; pressure; programs; prospective; routine care; ventilation

PROJECT SUMMARY Approximately 10% of neonates require assistance to begin breathing after birth. At-risk neonates, i.e., those requiring advanced resuscitation due to prematurity, brain injury, or other conditions, are at increased risk of mortality when born in a hospital without a neonatal intensive care unit (‘outborn’) compared to at-risk neonates born in a hospital with a NICU (‘inborn’). Furthermore, at-risk outborn neonates are more likely to suffer serious morbidity, e.g., pneumothorax, severe intraventricular hemorrhage (sIVH), and seizures, and receive cardiopulmonary resuscitation in the delivery room. We estimate that there are 10,000-15,000 at-risk outborn neonates each year who experience poorer health outcomes due to their birth location. However, there are limited strategies to optimize the resuscitation of at-risk neonates born in community hospitals that lack higher levels of neonatal care. There is a critical need to improve patient-important outcomes for this population. The overall objectives in this application are to (i) determine the impact of real-time, audio-video telemedicine consults provided by a neonatologist (termed teleneonatology) on the risk of early mortality and morbidity for at-risk outborn neonates, and (ii) evaluate the effect of teleneonatology on delivery room care provided to these neonates. The central hypothesis is that teleneonatology reduces early mortality and morbidity and improves delivery room care for at-risk outborn neonates. The rationale for this project is that teleneonatology brings resuscitation expertise to the bedside of at-risk neonates more effectively than a brief telephone consult, which is the current practice. Through teleneonatology, the neonatologist can visualize the neonate and provide step- by-step guidance to the community hospital care team. The central hypothesis will be tested by pursuing three specific aims: 1) Determine the impact of teleneonatology on the risk of early neonatal mortality (death within 7 days), 2) Identify the effect teleneonatology has on the risk of early morbidity (defined as pneumothorax, sIVH, or seizure during the first 7 days of life), and 3) Evaluate the impact of teleneonatology on delivery room care. The three aims are embedded into a single prospective, multi-center research trial. With sequential roll-out of the intervention using a cluster randomized stepped wedge design, neonatologists from four NICU ‘hub’ sites will provide teleneonatology consults to at-risk outborn neonates born at 27 community hospital ‘spoke’ sites. Completion of the proposed research will contribute the first-ever, high quality evidence on the impact of teleneonatology on neonatal health outcomes. The research is innovative because it uses video telemedicine to connect neonatologists exactly when needed to at-risk outborn neonates in a way that was not previously possible. This project is significant because it may identify an innovative care model that reduces the long- standing outcome disparities experienced by at-risk outborn neonates.

项目概要 大约 10% 的新生儿在出生后需要帮助才能开始呼吸，即高危新生儿。 由于早产、脑损伤或其他情况而需要高级复苏的风险增加 与高危新生儿相比，在没有新生儿重症监护病房的医院（“出生”）出生的死亡率 在设有 NICU 的医院出生（“先天”）此外，高危出生的新生儿更有可能遭受严重的痛苦。 发病率，例如气胸、严重脑室内出血 (sIVH) 和癫痫发作，并接受 我们估计产房内有 10,000-15,000 名高危新生儿。 每年都有一些新生儿因其出​​生地点而经历较差的健康状况。 对于缺乏较高水平的社区医院出生的高危新生儿，优化其复苏的策略有限 迫切需要改善该人群的患者重要结局。 该应用程序的总体目标是 (i) 确定实时音视频远程医疗咨询的影响 由新生儿科医生（称为远程新生儿学）提供有关高危人群早期死亡和发病风险的信息 已出生的新生儿，以及 (ii) 评估远程新生儿学对为这些新生儿提供的产房护理的影响 中心假设是远程新生儿学可以降低早期死亡率和发病率并改善 该项目的基本原理是远程新生儿学带来的好处。 与简短的电话咨询相比，向高危新生儿的床边提供复苏专业知识更有效 是目前的实践，通过远程新生儿学，新生儿科医生可以观察新生儿并提供步骤。 对社区医院护理团队的逐步指导将通过三个方面进行检验。 具体目标： 1) 确定远程新生儿学对新生儿早期死亡风险（7 天内死亡）的影响 2) 确定远程新生儿学对早期发病风险（定义为气胸、sIVH、 或出生后 7 天内癫痫发作），以及 3) 评估远程新生儿学对产房护理的影响。 这三个目标被纳入一项前瞻性、多中心研究试验中，并依次推出。 使用集群随机阶梯楔形设计进行干预，来自四个 NICU“中心”站点的新生儿科医生 将为 27 个社区医院“辐射点”出生的高危新生儿提供远程新生儿学咨询。 完成拟议的研究将提供有史以来第一个关于影响的高质量证据。 这项研究具有创新性，因为它使用了视频远程医疗。 在需要时以前所未有的方式将新生儿科医生与高危新生儿联系起来 该项目意义重大，因为它可能会确定一种创新的护理模式，以减少长期护理的时间。 高危出生新生儿所经历的长期结局差异。