Timing of Primary Surgery for Cleft Palate

腭裂初次手术时机

• 批准号: 7666755
• 负责人: William Christie Shaw
• 金额: $ 107.68万
• 依托单位: UNIVERSITY OF MANCHESTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7666755
• 关键词: 5 year old; Affect; Age; Birth; Blinded; Brazil; Caring; Child; Child Care; Cleaved cell; Cleft Lip; Cleft Palate; Consent; Denmark; Development; Enrollment; European; Family; Finland; Head; Hearing; Infant; International; Joints; Lead; National Institute of Dental and Craniofacial Research; Norway; Odontogenesis; Operative Surgical Procedures; Outcome; Palate; Parents; Randomized Controlled Trials; Research; Research Design; Site; Social Development; Speech; Surgical complication; Sweden; Time; cleft lip and palate; clinical research site; cost; craniofacial; dentofacial; evidence base; feeding; improved; member; programs; secondary outcome; skills; social integration; sound; trial comparing

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.

描述（由申请人提供）：孤立的left裂是最常见的颅面出生异常（例如，在美国，每10,000个出生4.5个）。它在喂养，言语，听力和牙科发育方面造成了问题。失败的手术可能无法解决这些问题，并减少孩子的社会发展和包容性的潜力。目前，有一个不足的证据基础来选择手术的最佳时机。但是，有一个合理的案例，可以在6个月内进行手术，而不是更常见的时间安排12个月，因为当言语技巧开始发展时，可正常的口感可能会导致更好的语音结果。将进行一项随机对照试验，以比较在6个月或12个月时期进行的手术结果。所有婴儿都将接受相同类型的paper手术。大约有650名婴儿将被招募，并遵循5岁。关键的包含变量是它们具有非综合性裂纹口味，他们被独立判断为医学上适合手术，他们的父母同意参加。主要结果将是由盲法评估评估的咽咽功能不足。次要结果将是手术并发症，表达，听力和牙本质发育。招聘将需要3年。这些发现将适用于世界任何地方的裂口儿童。这些临床场所将是一个国际裂口中心国际联盟的成员，他们最近完成了由欧洲委员会和NIDCR（NIDCR：Scandcleft Network）赞助的单方面裂口和papa仪的大规模试验的注册，该试验（10个手术现场（10个为丹麦，丹麦，芬兰，挪威，瑞典，瑞典和5个机构中心服务）;以及巴西的大型专业裂口中心（USP-HAC，Bauru）。项目叙述：改善left裂手术的证据基础将改善受影响儿童的治疗和社会融合，减轻补救护理的负担，即他们及其家人必须忍受，并降低与left裂相关的护理成本。