Treatment after Resolution of Neonatal Seizures

描述：在新生儿癫痫发作消退后用抗癫痫药物治疗婴儿是有争议的。婴儿通常在癫痫发作消退后接受苯巴比妥治疗，尽管缺乏支持这种做法的数据。发育中的大脑长时间暴露于苯巴比妥可能会产生有害后果。本申请的目的是计划进行一项多中心、随机、对照试验（RCT），以确定持续使用苯巴比妥治疗4个月是否会减少癫痫发作复发而不会对神经发育结局产生不良影响，或者如果不给予预防性药物，婴儿的结局是否会改善。本RCT计划阶段的目标是：（1）明确定义入选/排除标准和结局指标;（2）招募足够数量的合格中心，以便在2-3年内入组试验;（3）开发工具以加强试验的招募和保留。试点研究将在计划资助期内进行，以确定（1）通过视频脑电图监测的新生儿癫痫发作持续时间和（2）参与中心新生儿癫痫发作诊断和治疗的护理标准。试验本身将在NICHD新生儿研究网络中心内进行，并根据需要招募其他非网络中心。将成立一个研究委员会，由网络中心和非网络中心的代表组成，并在规划阶段为拟议的研究制定程序手册。该网络的人员和资源将可用于规划阶段的协商和合作，以及RCT的启动和实施。

DESCRIPTION: The treatment of infants with antiepileptic medications after the resolution of neonatal seizures is controversial. Infants are commonly treated with Phenobarbital after their seizures have resolved even though data to support this practice is lacking. Exposure of the developing brain to Phenobarbital for prolonged periods may have deleterious consequences. The purpose of this application is to plan for a multi-center, randomized, controlled trial (RCT) to determine if continued treatment with phenobarbital for 4 months reduces seizure recurrence without adversely affecting neurodevelopmental outcome or if infants' outcomes are improved if no prophylactic medication is given. The goals for the planning phase of this RCT are (1) to establish clear definitions for inclusion/exclusion criteria and outcome measures; (2) to recruit a sufficient number of qualified centers to allow enrollment into the trial within a 2-3 year period; and (3) to develop tools to enhance recruitment and retention in the trial. Pilot studies will be done within the Planning Grant period to determine (1) the duration of neonatal seizures by video-EEG monitoring and (2) the standard of care with respect to diagnosis and treatment of neonatal seizures in participating centers. The trial itself will be conducted within the NICHD Neonatal Research Network centers, with additional non- Network centers recruited as needed. A Study Committee with be formed consisting of representatives of both Network and non-Network centers and, during the planning phase, will develop the Manual of Procedures for the proposed study. The personnel and resources of the Network will be available for consultation and collaboration during the planning phase, as well as for initiation and performance of the RCT.