Long-Term Outcomes of NO for Ventilated Premature Babies

超出所提供的空间。与早产相关的呼吸衰竭是一个日益严重的公共卫生问题。虽然死亡率随着围产期护理的进步而下降，但这种情况消耗了相当多的医疗资源，并且越来越多地与令人担忧的长期发病率、发育迟缓和家庭负担相关。吸入一氧化氮（iNO）是一种选择性肺血管扩张剂，可改善呼吸衰竭足月新生儿的短期预后，可能对早产儿有益。因此，一项新的NHLBI资助的随机对照试验（NHLBI iNO RCT）将评估iNO对800名早产相关呼吸衰竭婴儿在孕龄36周时死亡率或氧依赖的综合终点的影响。然而，早产相关的呼吸衰竭与足月婴儿的呼吸衰竭有不同的病因，并且在现有的研究设计中没有捕捉到可能受iNO影响的广泛的长期后果。因此，我们建议延长和加强NHLBI在RCT中的后续工作。具体来说，我们的目标是评估使用INO对以下方面的影响：-长期临床和儿童发展结果；# 2。-家庭负担，以及；# 3。-与早产有关的呼吸衰竭的医疗费用。在目标#4中，我们将使用目标#1-3的数据来评估通气早产儿iNO的成本效益。我们将通过增加NHLBI的RCT数据收集来实现这些目标：1)平均43年的生存随访；ii)在1、2、3和4V2岁时进行全面、标准化的临床随访，以评估临床结果、儿童发育和家庭负担；（Iii）第一年每3个月对父母进行一次结构化电话访谈，此后平均4年每6个月对父母进行一次电话访谈，以评估慢性发病率和出院后医疗保健使用情况；（Iv）收集初级住院的详细医院账单；V.全面的分析计划。这项研究将使我们能够确定在这种情况下iNO治疗的长期后果，帮助临床医生、家庭和政策制定者，并立即影响危重婴儿的护理。通过与NHLBI随机对照试验相结合，我们利用了一个重要的机会，以随机的方式收集前瞻性的长期结果数据。我们的建议将通过从社会角度更好地理解iNO治疗的影响，显著提高RCT的投资回报。新生儿重症监护在过去十年中发生了巨大变化。本研究还将提供现代管理后早产儿相关呼吸衰竭长期预后的当代信息。最后，我们的数据将允许评估后续结果的早期代理的稳健性，这是该领域未来研究设计的关键。网站性能 ======================================== 节结束 ===========================================

EXCEED THE SPACE PROVIDED. Prematurity-associated respiratory failure is a growing public health problem. Although mortality has dropped with advances in perinatal care, this condition consumes considerable healthcare resources and is increasingly associated with worrisome long-term morbidity, developmental delay, and family burden. Inhaled nitric oxide (iNO), a selective pulmonary vasodilator that improves short-term outcomes in term neonates with respiratory failure, may benefit premature infants. Consequently, a new NHLBI-funded randomized controlled trial (NHLBI iNO RCT) will assess the effect of iNO on the combined end-point of mortality or oxygen dependency at 36 weeks post conceptional age in 800 infants with prematurity-associated respiratory failure. However, prematurity-associated respiratory failure has a different etiology from respiratory failure in term infants and the wide array of long-term consequences that may be affected by iNO are not captured under the existing study design. We therefore propose to extend and enhance the follow-up of the NHLBI iNO RCT. Specifically, we aim to assess the effects of INO use on: #1. - long-term clinical and childhood developmental outcomes; #2. - family burden, and; #3. - healthcare costs of prematurity-associated respiratory failure. Under aim #4, we will use data from aims #1-3 to assess the cost-effectiveness of iNO in ventilated premature infants. We will achieve these aims by augmenting the NHLBI iNO RCT data collection with: i.) survival follow-up for an average of 43 years; ii.) comprehensive, standardized follow-up clinic visits at 1,2, 3 and 4V2 years to assess clinical outcomes, childhood development, and family burden; iii.) structured telephone interviews with parents every 3 months in year 1 and every 6 months thereafter for an average of 4¿ years to assess chronic morbidity and post-discharge healthcare use; iv.) collection of detailed hospital bills for the primary hospitalization, and; v.) a comprehensive analysis plan. This study will allow us to determine the long-term consequences of iNO therapy in this condition, aiding clinicians, families, and policymakers and immediately affecting care of critically ill infants. By combining with the NHLBI iNO RCT, we take advantage of an important opportunity to gather prospective long-term outcome data in a randomized fashion. Our proposal will significantly increase the return on investment in the RCT through a greater understanding of the impact of iNO therapy from a societal perspective. Neonatal intensive care has changed dramatically in the last ten years. This study will also provide contemporary information on the long-term outcomes of prematurity-associated respiratory failure following modern management. Finally, our data will allow assessment of the robustness of early proxies for subsequent outcomes, key for future study design in this area. PERFORMANCE SITE ========================================Section End===========================================