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

项目总结 大约10%的新生儿在出生后需要帮助才能开始呼吸。高危新生儿，即那些 由于早产、脑损伤或其他情况而需要提前复苏的风险增加 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时的死亡率(‘出生儿’) 出生在有新生儿重症监护室的医院(“先天”)。此外，高危出生的新生儿更有可能遭受严重的 发病率，例如气胸、严重脑室出血(SIVH)和癫痫发作，并接受 在产房进行心肺复苏。我们估计有10,000-15,000名处于危险中的新生儿 每年因出生地点而健康状况较差的新生儿。然而，有一些 优化高危新生儿复苏的战略有限，这些高危新生儿出生在缺乏更高水平的社区医院 新生儿护理水平。对于这一人群来说，迫切需要改善患者重要的结局。这个 此应用程序的总体目标是：(I)确定实时、音频-视频远程医疗会诊的影响 由新生儿科医生(称为远程肿瘤学)提供，关于高危人群早期死亡和发病率的风险 以及(Ii)评估远程遗传学对为这些新生儿提供的产房护理的影响 新生儿。中心假设是远程遗传学降低了早期死亡率和发病率，并改善了 产房护理高危新生儿。这个项目的基本原理是远程遗传学带来了 向高危新生儿床边提供复苏专业知识比简短的电话咨询更有效，这 是目前的做法。通过远程遗传学，新生儿医生可以可视化新生儿，并提供步骤- 对社区医院护理团队进行循序渐进的指导。核心假设将通过追求三个方面来检验 具体目标：1)确定远程遗传学对早期新生儿死亡风险的影响(7岁以内死亡 天)，2)确定远程遗传学对早期发病风险的影响(定义为气胸、SIVH、 或出生后7天内的癫痫)，以及3)评估远程遗传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研究试验中。使用顺序推出的 干预采用整群随机阶梯楔形设计，来自NICU四个中心的新生儿专家 将为出生在27个社区医院“分支”地点的高危新生儿提供远程遗传学咨询。 拟议研究的完成将有助于提供有史以来第一个高质量的证据来证明 关于新生儿健康结局的远程遗传学。这项研究具有创新性，因为它使用了视频远程医疗 以一种前所未有的方式，在需要的时候准确地将新生儿医生与高危新生儿联系起来 有可能。该项目意义重大，因为它可能确定一种创新的护理模式，以减少长期- 高危新生儿所经历的长期结局差异。

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.