CLINICAL RESEARCH CENTER FOR NEONATAL SEIZURES

本合同的目的是建立一个临床研究中心 这将：a）工作建立统一、可复制和客观 数据收集、识别和诊断的方法 新生儿癫痫发作; B）确定新生儿癫痫的病因和病理生理学 癫痫发作，研究自然史，并确定预测因素 结果;和c）有助于临床理解， 新生儿癫痫发作的婴儿需要治疗， 是最安全和最有效的 本合同将授予为期四（4）年。 该组织是获得合同的两个中心之一， 目的陈述。这些中心应在共同的“核心”研究方面进行合作 同时也进行他们中心独有的调查 核心研究 包括一项前瞻性对照临床研究， 所有小于1500克的先天婴儿的新生儿癫痫发作和临床 研究新生儿癫痫发作的婴儿大于1500克。后续行动 两项研究均计划将至少2岁作为研究的一部分。 此外，本发明还提供了一种方法， 该中心将对新生儿进行更深入的研究， 脑电图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.