Urologic Management to Preserve Renal Function Protocol - Component C

维持肾功能方案的泌尿系统管理 - 成分 C

• 批准号: 10441104
• 负责人: Jonathan C Routh
• 金额: $ 2.5万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10441104
• 关键词: Urologic; Management; Preserve; Renal; Function

ABSTRACT The optimal urologic management of newborns and young children with spina bifida (SB) remains undefined. It is intuitive that early assessment of the neuropathic bladder in children with the myelomeningocele (MMC) form of SB by urodynamic testing and subsequent intervention for those at high risk for renal injury would be beneficial, but little data exist to prove superiority over observation. The Urologic Management to Preserve Initial Renal Function Protocol for Young Children with Spina Bifida (UMPIRE) study was conceived to closely evaluate and follow newborns with MMC in order to preserve initial renal function and allow these children to reach adulthood with the best possible renal and bladder outcomes. An iterative protocol was created to prospectively follow these children for the first five years of life on a set protocol. The Duke Comprehensive SB clinic was selected as one of the inaugural nine centers to enroll newborns into the study that was initiated in 2014 due in part to the size and diversity of Duke’s SB population and in part due to the clinical and scientific acumen of the pediatric urology team at Duke. Clinical-scientists at Duke have been instrumental in the implementation, initial evaluation, analysis, and dissemination of this protocol; in addition, Duke’s urology team has been heavily involved in SB activities, such as the Spina Bifida Association’s Professional Advisory Council, demonstrating our commitment to improving the lives of individuals living with SB and of their families. It is critical that the UMPIRE study be extended to continue to assess the currently enrolled children at Duke. The initial plan for UMPIRE analyses was that the initial 5 years of the UMPIRE protocol would focus on early bladder function and development of urinary tract infections. The second 5-year period will be focused on bowel and bladder continence outcomes, while the third 5-year period will focus more on renal outcomes and defining the most appropriate indications for urologic surgeries. Currently, no enrolled children have reached five years of age, meaning that the analyses of the first 5-year block are thus far not yet complete. Continued data ascertainment beyond five years of age and into school-aged years will allow UMPIRE researchers to better determine the long-term benefits and possible risks of the protocol towards achieving positive health outcomes for young children with SB. The primary aims for our continued participation in the UMPIRE study are 1) to continue to collect longitudinal data on previous enrolled patients according to the protocol, 2) continue to approach all infants with MMC who are 3 months old or younger for enrollment, and 3) continue the leadership role of our clinical-scientists in the refinement of data collection, analysis of data, and dissemination of findings. Specific newly proposed aims include demonstrating the reliability of the urodynamic categorization used in the UMPIRE study, determining if sonographic renal length measurements are helpful in the longitudinal follow up of young children with SB, and examining the incidence of UTI in study participants to determine if the practice of antibiotic prophylaxis should be expanded or contracted.

摘要