Baylor/Texas Children's Hospital Pediatric Heart Network

贝勒/德克萨斯儿童医院儿科心脏网络

• 批准号: 8181942
• 负责人: Dean B. Andropoulos
• 金额: $ 44.06万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8181942
• 关键词: Acute; Acute Brain Injuries; Address; Adopted; Adult; Age-Months; Anatomy; Anesthesiology; Applications Grants; Arrhythmia; Blood Pressure; Blood flow; Brain; Brain Injuries; Cardiac; Cardiac Catheterization Procedures; Cardiac Surgery procedures; Cardiology; Cardiopulmonary Bypass; Cardiovascular system; Cerebrovascular Circulation; Cerebrum; Child; Childhood; Clinical; Clinical Research; Clinical Research Protocols; Clinical Trials Design; Common Ventricle; Complex; Congenital Heart Defects; Critical Care; Data; Diagnosis; Echocardiography; Event; Experimental Animal Model; Future; Goals; Health Status; Heart; Heart Diseases; Human; Infant; Inflammatory; Lead; Leadership; Life; Magnetic Resonance Imaging; Medicine; Methods; Monitor; Multicenter Studies; Myocardium; Myopathy; National Heart, Lung, and Blood Institute; Neonatal; Neurologic; Neurological outcome; Operative Surgical Procedures; Outcome; Oxygen; Patients; Pediatric Hospitals; Perfusion; Perioperative; Physiological; Postoperative Period; Principal Investigator; Procedures; Publishing; Randomized; Randomized Controlled Trials; Structure of brachiocephalic artery; Texas; Therapeutic; Time; United States; Vulnerable Populations; aortic arch; clinical care; clinical practice; cohort; college; design; electronic data; experience; improved; multidisciplinary; neonate; neuroprotection; patient population; prospective; reconstruction

DESCRIPTION (provided by applicant): The purpose of this grant application is for Baylor College of Medicine/Texas Children's Hospital (TCH) Heart Center to become a Clinical Center of the Pediatric Heart Network sponsored by NHLBI. The goal of the PHN is to evaluate therapeutic and management strategies for children and adults with congenital heart defects and for children with inflammatory heart disease, heart muscle disease, and arrhythmias through multicenter clinical research. Baylor/TCH Heart Center has experienced multidisciplinary leadership in Cardiology, Cardiac Surgery, Cardiac Critical Care, and Cardiovascular Anesthesiology. TCH has a large patient population with diverse diagnoses undergoing over 550 open heart cases, 1000 cardiac catheterizations, 17,000 echocardiograms, and encountering more than 80 new infants with single ventricle anatomy annually. With these qualifications, Baylor/TCH Heart Center proposes to become a major contributing Clinical Center of the PHN. The clinical research protocol for this application compares regional cerebral perfusion (RCP) vs. deep hypothermic circulatory arrest (DHCA). During neonatal aortic arch reconstruction, RCP duplicates conditions achieved with DHCA, a procedure that has been associated with adverse acute and long term neurological outcomes. RCP has been widely adopted in the past decade without extensive supporting data, either in experimental animal models, or human outcomes. There is only one small single center prospective randomized controlled trial of RCP vs. DHCA, finding no difference in neurodevelopmental outcome at 1 year. The Single Ventricle Reconstruction Trial, in the same patient population, was not designed to collect neurological data or assess long term neurodevelopmental outcome. We are proposing a multicenter, prospective, randomized, controlled trial which is adequately powered, to compare early and longer term neurodevelopmental outcomes with RCP vs. DHCA. Our hypothesis is that RCP will lead to improved neurodevelopmental outcomes vs. DHCA. RELEVANCE: This large multicentered study is designed to determine the preferred method of cardiopulmonary bypass for neonatal aortic arch reconstruction. If as hypothesized, regional cerebral perfusion results in a better neurodevelopmental outcome at 18-22 months, this is expected to change practice, and improve lifelong health status for a significant portion of the approximately 9000 infants who undergo cardiac surgery in the first year of life annually in the United States.

描述（由申请人提供）： 此项拨款申请的目的是让贝勒医学院/德克萨斯儿童医院 (TCH) 心脏中心成为 NHLBI 赞助的儿科心脏网络的临床中心。 PHN 的目标是通过多中心临床研究评估患有先天性心脏病的儿童和成人以及患有炎症性心脏病、心肌疾病和心律失常的儿童的治疗和管理策略。贝勒/TCH 心脏中心在心脏病学、心脏外科、心脏重症监护和心血管麻醉学方面拥有丰富的多学科领导经验。 TCH 拥有大量具有不同诊断的患者群体，每年接受 550 多例心脏直视病例、1000 例心导管检查、17,000 例超声心动图检查，并接诊 80 多名单心室新生儿。凭借这些资格，贝勒/TCH 心脏中心拟成为 PHN 的主要贡献临床中心。 该应用的临床研究方案对区域脑灌注 (RCP) 与深低温停循环 (DHCA) 进行了比较。在新生儿主动脉弓重建过程中，RCP 重复了 DHCA 所达到的条件，DHCA 是一种与急性和长期神经系统不良后果相关的手术。 RCP 在过去十年中已被广泛采用，但无论是在实验动物模型还是在人类结果中，都没有大量的支持数据。只有一项关于 RCP 与 DHCA 的小型单中心前瞻性随机对照试验，发现 1 年神经发育结果没有差异。在同一患者群体中进行的单心室重建试验并非旨在收集神经学数据或评估长期神经发育结果。 我们正在提议开展一项具有足够功效的多中心、前瞻性、随机对照试验，以比较 RCP 与 DHCA 的早期和长期神经发育结果。我们的假设是，与 DHCA 相比，RCP 将改善神经发育结果。 相关性：这项大型多中心研究旨在确定新生儿主动脉弓重建的首选体外循环方法。如果按照假设，局部脑灌注可在 18-22 个月时带来更好的神经发育结果，那么这有望改变实践，并改善美国每年在生命第一年接受心脏手术的约 9000 名婴儿中的很大一部分的终身健康状况。