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: 8306750
• 负责人: Dean B. Andropoulos
• 金额: $ 44.93万
• 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/8306750
• 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）： 本拨款申请的目的是贝勒医学院/得克萨斯州儿童医院（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。Baylor/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具有多学科领导地位。TCH有大量的患者人群，诊断多种多样，每年接受超过550例心脏直视手术，1000例心脏导管插入术，17，000例超声心动图检查，并遇到超过80例单心室解剖的新生儿。有了这些资格，贝勒/TCH心脏中心建议成为PHN的主要贡献临床中心。 该应用的临床研究方案比较了局部脑灌注（RCP）与深低温停循环（DHCA）。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是一种与不良急性和长期神经结局相关的手术。 在过去的十年中，RCP被广泛采用，但无论是在实验动物模型还是人类结局中，都没有广泛的支持数据。只有一项RCP与DHCA的小型单中心前瞻性随机对照试验，发现1年时神经发育结局无差异。在同一患者人群中进行的单髁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局。 我们提议进行一项多中心、前瞻性、随机、对照试验，该试验具有足够的把握度，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将导致神经发育结局的改善。 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。如果如假设的那样，局部脑灌注在18-22个月时导致更好的神经发育结果，则预计这将改变实践，并改善美国每年在出生后第一年接受心脏手术的约9000名婴儿中相当一部分的终身健康状况。