Timing of Primary Surgery for Cleft Palate

描述(申请人提供)：孤立性腭裂是最常见的头面部出生畸形(例如，在美国，每10,000名新生儿中有4.5名)。它会在进食、说话、听力和牙齿发育方面造成问题。手术可能无法解决这些问题，并降低儿童的社会发展和包容性的潜力。“腭裂初次手术时机”试验的目的是调查腭裂手术时机对语音结果的影响，数据协调中心(DCC)将支持试验活动，为试验方案的制定、实施和成功完成提供行政、后勤和生物统计学支持。为了实现这一目标，DCC将：1)积极参与试验范围的委员会；2)管理开展国际研究所需的信息系统，利用安全的研究专用网络门户，促进DCC和站点协调员之间的随机化、数据输入和交流；3)协调总体研究活动，包括安排会议和电话会议，记录和分发会议记录，并准备研究材料；4)安排和进行研究人员关于数据收集、数据输入和试验监测的持续培训；5)进行中央监测，并与行政站点合作进行年度现场访问，以监测站点是否符合良好临床实践指南；6)监测现场数据采集和数据录入的招募和及时性，并对所有研究数据执行质量保证程序；7)跟踪言语、临床、遗传和听力数据的收集和传输，准备并监督最终(“锁定”)研究数据的分发；8)在整个研究过程中提供统计专门知识，包括监测随机化程序，编写提交给数据和安全监测委员会的报告，并执行分析最终研究数据的统计分析计划；9)为出版物编写手稿，以传播研究结果；10)准备一个公共网页，以提供关于试验结果的(非正式的)信息；以及11)存档所有相关的源文件，以便在试验完成后(例如，在当局检查的情况下)可以将试验数据与源数据进行比较。项目简介：改善腭裂手术的证据基础将改善受影响儿童的治疗和社会融合，减少他们及其家人必须忍受的补救护理负担，并降低与腭裂相关的护理成本。

DESCRIPTION (provided by applicant): Isolated cleft palate is the commonest craniofacial birth anomaly (e.g., 4.5 per 10,000 births in the US). It creates problems in feeding, speech, hearing, and dental development. Surgery may fail to resolve these problems and reduce the child's potential for social development and inclusion. The purpose of the "Timing of Primary Surgery for Cleft Palate" trial is to investigate the influence of the timing of cleft palate surgery on speech outcomes and the Data Coordinating Center (DCC) will support the activities of the trial with the provision of administrative, logistical, and biostatistical support for the development, implementation, and successful completion of the trial protocol. To accomplish this objective, the DCC will: 1) actively participate on trial-wide committees; 2) manage the information systems required to conduct an international study utilizing a secure study-specific web portal to facilitate randomization, data entry, and communication between the DCC and site coordinators; 3) coordinate overall study activities, including scheduling meetings and conference calls, recording and distributing minutes, and preparing study materials; 4) arrange for and conduct ongoing training of study staff with respect to data collection, data entry, and trial monitoring; 5) conduct central monitoring and conduct yearly site visits, in partnership with the administrative site, to monitor site compliance with Good Clinical Practice guidelines; 6) monitor recruitment and timeliness of data acquisition and data entry at sites and carry out quality assurance procedures on all study data; 7) track the collection and transfer, of speech, clinical, genetic and audiological data and prepare and oversee distribution of the final ("locked") study data; 8) provide statistical expertise throughout the study to include monitoring of the randomization routine, preparation of reports to the Data and Safety Monitoring Board and execute the statistical analysis plan for analysis of final study data; 9) prepare manuscripts for publications to disseminate study findings; 10) prepare a public web page to provide information (in lay terms) regarding trial findings; and 11) archiving of all relevant source documents so that the trial data can be compared against source data after completion of the trial (e.g. in case of inspection from authorities). Project Narrative: Improving the evidence base for cleft palate surgery will improve the treatment and social integration of affected children, reduce the burden of remedial care that they and their families must endure, and reduce the cost of care associated with cleft palate.