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

先天性听力手术后 ADHD（注意力缺陷多动障碍）

• 批准号: 7286294
• 负责人: VICTORIA L VETTER
• 金额: $ 19.9万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-13 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7286294
• 关键词: 12 year old; Affect; Age; Age-Months; Age-Years; Area; Arrhythmia; Attention; Attention deficit hyperactivity disorder; Behavior; Cardiac; Cardiac Surgery procedures; Cardiology; Cardiopulmonary Bypass; Caring; Child; Childhood; Clinical; Clinical Trials; Congenital Heart Defects; Development; Event; Exposure to; Faculty; General Population; Goals; Hearing; Heart; Heart Diseases; High Prevalence; Home environment; Hyperactive behavior; Living Wills; Measures; Mutation; Numbers; Operative Surgical Procedures; Patients; Pediatric Hospitals; Performance; Perioperative; Pharmaceutical Preparations; Pharmacotherapy; Philadelphia; Population; Postoperative Period; Prevalence; Procedures; Quality of life; Randomized; Rate; Recording of previous events; Research Infrastructure; Research Personnel; Residual state; Risk; Risk Factors; Safety; Sampling; School-Age Population; Score; Serious Adverse Event; Standards of Weights and Measures; Survivors; Symptoms; Techniques; Testing; Time; Victoria Austrailia; abstracting; clinically significant; congenital heart disorder; double-blind placebo controlled trial; early childhood; experience; hemodynamics; improved; inattention; infancy; innovation; programs

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).

描述（由申请人提供）： 在过去的十年中，先天性心脏病（CHD）的生存率已大大改善，导致幸存者数量越来越多。公认的先天性心脏手术手术后遗症包括残留的血液动力学异常和心律不齐。现在已经认识到，这种手术的神经发育后遗症是重要的。具体而言，由于注意力不集中和多动症问题，许多学龄儿童受到挑战。也就是说，它们似乎患有注意力缺陷多动障碍（ADHD）。有证据表明，在手术后冠心病患者中，多动症比普通人群更为普遍。此外，冠心ADHD患者似乎还没有治疗。因此，这项研究的主要目的包括1）确定在婴儿期或幼儿期使用心肺旁路手术的CHD儿童中ADHD的患病率； 2）比较与暴露于心肺旁路的年龄相关的多动症的患病率，以及对CPB的多次暴露以及可能被利用的不同辅助支持技术的影响； 3）识别和比较可能影响发展多动症可能性的患者，手术和术后风险因素的种类，包括先天性心脏缺陷类型，遗传底物，所需的手术程序，手术因素和围手术期事件； 4）测试用于治疗术后心脏人群中多动症的刺激药物的安全性和功效。尽管研究表明，其中许多儿童患有多动症，并且有可能从大多数人群中有效的标准刺激药物治疗中受益，但对心脏安全性的担忧严重限制了其在心脏病儿童中的使用。由于未尝试对该人群中刺激药物的安全研究，因此我们提出了两种最常用的刺激药物的随机双盲安慰剂对照试验，以确定其术后心脏儿童的疗效和真实风险水平。这些信息将使临床医生能够在适当的心脏患者中安全地使用这些潜在的有效药物，从而改善了这些有特殊需要的儿童的生活质量。费城儿童医院（CHOP）心脏病学部门和心脏中心具有临床创新和心脏护理卓越的杰出历史，具有专业知识的大量专业课程都是儿科心脏病学和心胸外科手术的所有领域。 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，并增强了小儿心脏网络的目标和长期目标的可能性。 （摘要结束）。