CLINICAL RESEARCH CENTER FOR NEONATAL SEIZURES

这份合同的目标是建立一个临床研究中心 这将：a)工作建立统一、可重复和客观的 数据收集、识别和诊断的方法 新生儿癫痫；b)确定新生儿的病因和病理生理学 癫痫发作，研究自然历史，并确定预测因素 结果；以及c)有助于临床了解 患有新生儿癫痫的婴儿需要治疗以及可能的治疗方法 成为最安全、最有效的。 该合同的授予期限为四(4)年。 该组织是被授予合同的两个中心之一 所述目的。这些中心应就共同的“核心”研究进行合作。 以及进行他们中心独有的调查。核心研究 包括一项关于自然病史的前瞻性对照临床研究 所有小于1500克的出生婴儿的新生儿癫痫发作和临床 大于1500克的新生儿惊厥的研究。跟进到 两项研究都计划将年龄至少为2岁的儿童作为研究的一部分。此外, 该中心将对新生儿进行更深入的研究 脑电图学和新生儿癫痫的流行病学。

The objective of this contract is to establish a clinical research center that will: a) work establish uniform, reproducible, and objective methodologies for data collection and identification and diagnosis of neonatal seizures; b) determine etiology and pathophysiology of neonatal seizures, to study natural history, and to determine factors predictive of outcome; and c) contribute to the clinical understanding regarding which infants with neonatal seizures require treatment and what treatment might be the safest and most effective. This contract will be awarded for a period of four (4) years. This organization is one of two centers to be awarded contracts for the purpose stated. These centers shall collaborate on common "core" studies as well as pursue investigations unique to their center. The core studies include a prospective controlled clinical study of the natural history of neonatal seizures on all inborn infants less than 1500 grams and a clinical study of neonatal seizures in infants greater than 1500 grams. Followup to at least age 2 years is planned as a part of both studies. In addition, this center will pursue more in-depth studies of neonatal electroencephalography and the epidemiology of neonatal seizures.