Outcomes of Furlow&Conventional Palatoplasty Procedures

弗洛的结果

• 批准号: 6507873
• 负责人: ROBERT J HAVLIK
• 金额: $ 11.29万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2004-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6507873
• 关键词: behavioral /social science research tag; cleft palate; clinical research; clinical trials; human subject; human therapy evaluation; infant human (0-1 year); language development; oral facial restoration; oral pharyngeal surgery; outcomes research; patient oriented research; postoperative complications; preschool child (1-5); speech disorders

DESCRIPTION (provided by applicant): This clinical trial planning grant is to design a multi-center, multi-disciplinary prospectively randomized trial to evaluate the outcomes following two cleft palate repair techniques--Furlow double-Z palatoplasty (Double Z) and intra-velar veloplasty (IVV). The specific aims of the study are to determine if the primary endpoints of the occurrence of oro-nasal fistulae and the rate of velopharyngeal insufficiently of children undergoing double Z or IVV palatoplasty at 10-12 months of age are the same. It is also believed that cleft type and cleft width may influence these primary endpoints, a series of specific measurements of palatal architecture will be made at the time of palatal repair. Secondary endpoints will be to determine if the occurrence of oro-nasal fistulae or velopharyngeal competence differs as a result of any of these architectural parameters in the two techniques of palatal repair. Patients will be recruited from four major referral sites: Riley Hospital for Children, Children's Medical Center of Akron, Mott Children's Hospital and Children's Mercy Hospital in Kansas City. Total planned enrollment in the trial is 300 cleft patients over three years. Prior to surgery, appropriate screens will be performed to exclude patients with cognitive delay, sensori-neuronal hearing loss, or neuromuscular disorders. All non-syndromic patients with cleft palate, with or without cleft lip, will be offered participation in the trial. Audiology testing will be performed throughout the study to minimize the influence of hearing loss upon the data. A speech-language assessment will be performed at nine months of age, and follow-up speech language assessments will be at six-month intervals until 36 months of age, and on an annual basis thereafter until six years of age, or until secondary surgical management is recommended. In addition, a master tape at the 48-month visit will be sent to five independent speech-language pathologists for evaluation in a blinded fashion. Velopharyngeal assessment will be made using nasometry management and analysis will be performed through a separate data center. There are no randomized controlled trials published that compare these techniques of double Z or IVV, and, furthermore, there have been very few randomized trials published in cleft studies, despite this being the third most common birth defect. In addition, there have been no studies on the palatal architecture parameters and their influence upon oronasal fistulae and velopharyngeal competence that have been published.

描述（由申请人提供）： 这项临床试验计划资助是设计一项多中心，多学科的前瞻性随机试验，以评估两种腭裂修复技术-Furlow双Z腭裂修复术（Double Z）和软腭内修复术（IVV）的结果。 本研究的具体目的是确定在10-12个月时接受双Z或IVV腭成形术的儿童的口鼻瘘发生率和咽喉功能不全发生率的主要终点是否相同。 腭裂类型和宽度也可能影响这些主要终点，在腭裂修复时将进行一系列具体的腭结构测量。 次要终点是确定两种腭修复技术中的任何这些结构参数是否会导致口鼻瘘或咽喉功能的发生不同。 患者将从四个主要的转诊地点招募：莱利儿童医院、阿克伦儿童医疗中心、莫特儿童医院和堪萨斯城的儿童慈善医院。 该试验计划在三年内招募300名唇腭裂患者。 手术前，将进行适当的筛查，以排除认知延迟、感觉神经元听力损失或神经肌肉疾病的患者。 所有非综合征性腭裂患者（伴或不伴唇裂）将参加本试验。 将在整个研究期间进行听力学测试，以尽量减少听力损失对数据的影响。 将在9个月大时进行言语语言评估，并每隔6个月进行一次后续言语语言评估，直至36个月大，此后每年进行一次，直至6岁，或直至建议进行二次手术治疗。 此外，将48个月访视时的母带发送给5名独立的语言病理学家，以盲态方式进行评价。 将使用鼻测量管理进行腭咽评估，并通过单独的数据中心进行分析。 目前还没有发表比较双Z或IVV技术的随机对照试验，而且，尽管这是第三大常见的出生缺陷，但在唇腭裂研究中发表的随机试验很少。 此外，还没有关于腭结构参数及其对口鼻瘘和咽喉功能影响的研究发表。