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，在美国，每10,000个新生儿中有4.5个）。它会造成进食、语言、听力和牙齿发育方面的问题。不成功的手术可能无法解决这些问题，并降低儿童社会发展和融入的潜力。目前，选择最佳手术时机的证据不足。然而，在6个月大的时候进行手术是合理的，而不是通常的12个月大的时候，因为在语言技能开始发展的时候提供一个功能健全的上颚可能会导致更好的语言效果。将进行一项随机对照试验，比较6月龄和12月龄手术的结果。所有婴儿都将接受相同类型的上颚手术。大约650名婴儿将被招募并随访至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，以及他们的父母同意参与。主要结果将是盲法评价的腭咽功能不足。次要结果是手术并发症、关节、听力和牙面发育。招聘将需要3年时间。这一发现将适用于世界上任何地方的腭裂儿童。临床站点将是国际唇裂中心联盟的成员，该联盟最近完成了925名婴儿参加由欧洲委员会和NIDCR赞助的单侧唇裂和腭裂的大规模试验：Scandcleft网络（10个手术站点服务于丹麦、芬兰、挪威和瑞典以及英国的5个区域中心）；以及巴西的大型专业裂缝中心（USP-HRAC, Bauru）。项目说明：改善腭裂手术的证据基础将改善腭裂患儿的治疗和社会融合，减轻患儿及其家庭必须承受的补救护理负担，并降低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.