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: 8514058
• 负责人: Dean B. Andropoulos
• 金额: $ 31.03万
• 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/8514058
• 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)： 这项拨款申请的目的是为了让贝勒医学院/德克萨斯儿童医院(TCH)心脏中心成为由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、心脏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多学科的领导经验。TCH拥有庞大的患者群体，接受了超过550例心内直视手术、1000例心导管置入术和17,000例超声心动图检查，每年有80多名新出生的单心室解剖婴儿。凭借这些资格，贝勒/TCH心脏中心计划成为PHN的主要贡献临床中心。 这一应用的临床研究方案比较了局部脑灌注(RCP)和深低温停循环(DHCA)。在新生儿腹主动脉弓重建过程中，RCP复制了深低温心脏骤停所达到的条件，而深低温体外循环已被认为与不良的急性和长期神经后果有关。在过去的十年里，RCP在没有广泛支持数据的情况下被广泛采用，无论是在实验动物模型中，还是在人类结果中。只有一个小规模的单中心前瞻性随机对照试验，RCP与DHCA比较，发现1年后的神经发育结果没有差异。在同一患者群体中进行的单一脑室重建试验，并不是为了收集神经学数据或评估长期神经发育结果而设计的。我们建议进行一项多中心、前瞻性、随机化、对照试验，该试验要有足够的动力，以比较RCP和DHCA的早期和长期神经发育结果。我们的假设是，RCP将导致改善神经发育结局，而不是DHCA。 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。如果正如假设的那样，区域脑灌注在18-22个月时能产生更好的神经发育结果，这将有望改变做法，并改善美国每年约9000名出生第一年接受心脏手术的婴儿中相当大一部分人的终身健康状况。