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.

项目摘要 大约10%的新生儿在出生后需要辅助开始呼吸。高危新生儿，即，那些 由于早产、脑损伤或其他情况而需要高级复苏的患者， 与高危新生儿相比，在没有新生儿重症监护室的医院出生的死亡率（“外生儿”） 出生在医院的新生儿重症监护室（“先天性”）。此外，有风险的外生新生儿更有可能遭受严重的 发病率，例如，气胸、严重脑室内出血（sIVH）和癫痫发作，并接受 在产房做心肺复苏我们估计有10，000 - 15，000名有风险的未出生婴儿 由于出生地的原因，每年有许多新生儿的健康状况较差。但有 有限的策略，以优化复苏的高危新生儿出生在社区医院，缺乏更高的 新生儿护理水平。迫切需要改善该人群的患者重要结局。的 本应用的总体目标是：（i）确定实时音视频远程医疗会诊的影响 由儿科医生（称为teleneonatology）提供的关于高危人群早期死亡率和发病率风险的信息。 未出生的新生儿，（ii）评估远程新生儿学对提供给这些新生儿的产房护理的影响 新生儿。中心假设是，teleneonology降低早期死亡率和发病率，并改善 为有风险的早产儿提供产房护理。这个项目的基本原理是，远程新生儿学带来了 复苏的专业知识，以床旁的危险新生儿更有效地比一个简短的电话咨询， 这是目前的做法。通过远程新生儿学，产科医生可以看到新生儿，并提供步骤- 逐步指导社区医院护理团队。中心假设将通过追求三个测试 具体目标：1）确定远程新生儿学对早期新生儿死亡风险的影响（7岁内死亡）， 天），2）确定远程医学对早期发病率（定义为气胸，sIVH， 或在出生后的前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。 这三个目标被嵌入到一个单一的前瞻性，多中心的研究试验。随着顺序推出 干预采用整群随机阶梯楔形设计，来自四个NICU“中心”站点的儿科医生 将为27个社区医院“辐条”站点出生的高危新生儿提供远程新生儿咨询。 完成拟议的研究将有助于有史以来第一次，高质量的证据的影响， 远程新生儿医学对新生儿健康的影响。这项研究是创新的，因为它使用视频远程医疗 以一种以前没有的方式， 可能该项目意义重大，因为它可能会确定一种创新的护理模式，减少长期- 存在风险的外生新生儿经历的长期结局差异。