ADHD (Attention Deficit Hyperactivity Disorder) after Surgery for Congenital Hear

描述(由申请人提供)： 在过去的十年里，患有先天性心脏病(CHD)的儿童的存活率有了显著的提高，导致幸存者的数量不断增加。公认的先天性心脏手术的后遗症包括残留的血流动力学异常和心律失常。现在人们认识到，这种手术的神经发育后遗症是实质性的。具体地说，许多学龄儿童因为注意力不集中和多动问题而受到挑战；也就是说，他们似乎患有注意力缺陷多动障碍(ADHD)。有证据表明，多动症在术后冠心病患者中比在普通人群中更普遍。此外，CHD-ADHD患者似乎没有得到治疗。因此，这项研究的主要目的包括：1)确定婴儿期和幼儿期接受体外循环手术的冠心病儿童中ADHD的患病率；2)比较与体外循环暴露年龄相关的ADHD患病率以及多次暴露于CPB和可能使用的不同辅助支持技术的影响；3)识别和比较各种可能影响ADHD发生的患者相关、手术和术后危险因素，包括先天性心脏病的类型、遗传基础、所需外科手术、手术因素和围手术期事件；以及4)在心脏术后人群中测试用于治疗ADHD的兴奋剂的安全性和有效性。虽然研究表明，这些儿童中的许多人患有ADHD，并可能从在大多数人群中有效的标准刺激药物疗法中受益，但对心脏安全的担忧严重限制了其在心脏病儿童中的使用。由于在这一人群中没有对兴奋剂药物的安全性研究，我们建议对这两种最常用的兴奋剂药物进行随机、双盲、安慰剂对照试验，以确定它们在心脏术后儿童中的有效性和真实风险水平。这些信息将使临床医生能够在适当的心脏病患者中安全地使用这些潜在有效的药物，改善这些有特殊需求的儿童的生活质量。费城儿童医院(CHOP)心脏科和心脏中心在心脏护理方面有着卓越的临床创新和卓越的历史，具有专业知识的高容量项目是儿科心脏病学和心胸外科的所有领域。CHOP和心脏中心的教职员工是多中心临床试验和研究的经验丰富的研究人员。机构优势和基础设施支持临床研究，并提高了实现儿科心脏网络的目标和长期目标的可能性。(摘要结束)。

DESCRIPTION (provided by applicant): Over the past decade the survival of children with congenital heart disease (CHD) has improved significantly, leading to an increasing number of survivors. Recognized sequelae of surgery for congenital heart surgery include residual hemodynamic abnormalities and arrhythmias. It is now being recognized that the neurodevelopmental sequelae of this type of surgery are substantial. Specifically, many school age children are challenged because of problems with inattention and hyperactivity; that is, they appear to have attention deficit hyperactivity disorder (ADHD). There is evidence that ADHD is more prevalent in the post surgery CHD patients than in the general population. In addition, the CHD-ADHD patients seem to be under treated. Thus, the primary aims of this study include 1) to determine the prevalence of ADHD in the population of children with CHD undergoing surgery using cardiopulmonary bypass in infancy or early childhood; 2) to compare the prevalence rates of ADHD associated with age of exposure to cardiopulmonary bypass as well as the effect of multiple exposures to CPB and different adjunctive support techniques that may be utilized; 3) to identify and compare the variety of patient related, operative and postoperative risk factors that could affect the likelihood of developing ADHD, including type of congenital heart defect, genetic substrate, surgical procedure required, operative factors, and perioperative events; and 4) to test the safety and efficacy of stimulant medications used to treat ADHD in a postoperative cardiac population. While studies suggest that many of these children have ADHD and could potentially benefit from the standard stimulant drug therapy effective in most of the population, concerns over cardiac safety has severely limited its use in children with heart disease. As no safety studies of the stimulant drugs in this population have been attempted, we propose a randomized double blind placebo controlled trial of the two most commonly used stimulant medications to determine their efficacy and true level of risk in postoperative cardiac children. This information will allow clinicians to use these potentially effective drugs safely in appropriate cardiac patients, improving the quality of life for these children with special needs. The Children's Hospital of Philadelphia (CHOP) Cardiology Division and Cardiac Center have a distinguished history of clinical innovation and excellence in cardiac care, a high volume program with expertise is all areas of pediatric cardiology and cardiothoracic surgery. The faculty of the CHOP and Cardiac Center are experienced investigators in multicenter clinical trials and studies. The institutional strengths and infrastructure support clinical investigations and enhance the likelihood that the aims and long term goals of the Pediatric Heart Network will be achieved. (End of Abstract).