Timing of Primary Surgery for Cleft Palate

描述（由申请人提供）：孤立性腭裂是最常见的颅面出生异常（例如，4.5在美国，每10，000名新生儿）。它会在进食、言语、听力和牙齿发育方面产生问题。不成功的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的潜力。在这个时候，没有充分的证据基础来选择最佳的手术时机。然而，有一个合理的情况下，在6个月，而不是更常见的时间12个月进行手术，因为当语言技能开始发展时，提供一个功能性腭可能会导致更好的语言结果。将进行一项随机对照试验，以比较在6个月或12个月时进行手术的结局。所有婴儿将接受相同类型的腭手术。大约650名婴儿将入组并随访至5岁。关键的纳入变量是他们患有非综合征性腭裂，他们被独立地判断为医学上适合手术，并且他们的父母同意参与。主要结局将是由设盲法官评估的咽功能不足。次要结局将是手术并发症、关节、听力和牙面发育。招聘需要3年时间。这一发现将适用于世界任何地区的腭裂儿童。这些临床研究中心将是一个国际唇腭裂中心联盟的成员，该联盟最近完成了925名婴儿参加由欧盟委员会和NIDCR赞助的单侧唇腭裂大规模试验：Scandcleft网络（10个手术中心，服务于丹麦、芬兰、挪威和瑞典以及英国的5个区域中心）;和巴西的一个大型专门的唇腭裂中心（USP-HRAC，Bauru）。项目叙述：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，减轻他们及其家庭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. Unsuccessful surgery may fail to resolve these problems and reduce the child's potential for social development and inclusion. At this time there is an inadequate evidence base for selecting the optimal timing for surgery. There is however a plausible case for undertaking surgery at 6 months, rather than the more usual timing of 12 months, as the provision of a functioning palate when speech skills begin to develop may lead to better speech outcomes. A randomized control trial will be undertaken to compare the outcomes of surgery performed either at age 6 months or at age 12 months. All infants will receive the same type of palate surgery. Approximately 650 infants will be enrolled and followed until age 5 years. The key inclusion variables are that they have non-syndromic cleft palate, they have been independently judged to be medically fit for surgery, and their parents consent to participation. The main outcome will be insufficient velopharyngeal function assessed by blinded judges. Secondary outcomes will be surgical complications, articulation, hearing, and dentofacial development. Recruitment will take 3 years. The findings will be applicable to children with cleft palate in any part of the world. The clinical sites will be members of an international consortium of cleft centers who recently completed enrollment of 925 infants into large scale trials of unilateral cleft lip and palate sponsored by the European Commission and NIDCR: the Scandcleft Network (10 surgical sites serving all of Denmark, Finland, Norway and Sweden and five regional centers in the UK); and a large specialized cleft center in Brazil (USP-HRAC, Bauru). 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.