Management of Myelomeningocele Study

描述(申请人提供)：脊髓脊膜膨出管理研究(MOMS)是一项多中心非盲法随机临床试验，在加州大学旧金山分校、费城儿童医院和范德比尔特大学医学中心三个临床中心和一个数据协调中心进行。该试验的主要目的是确定宫内修复妊娠19 0至2 5 6周的胎儿MMC是否改善结局，通过1)死亡或需要1年的脑室减压术，以及2)校正年龄30个月时的综合神经功能评分来衡量。 在患有脊柱裂的儿童中，只有一小部分出生时膀胱和括约肌的神经正常，并有终生的泌尿系统后遗症。MMC的产前手术对随后的尿能功能的影响尚不清楚，但确定是至关重要的。这项建议是对MOMS试验的补充，以启动对试验中的婴儿进行更严格的泌尿科随访。预计120名婴儿将在研究期间的三个时间点接受肾脏超声、视频尿流动力学和尿液分析、培养和敏感性检查，分别在新生儿分娩后出院前、12个月和30个月校正年龄时进行。该补充的目的是确定开放性MMC的宫内治疗是否会影响尿路感染的预后，以及是否需要间歇性动脉插管。一个由三名独立的儿科泌尿科医生组成的委员会将审查医疗记录和影像研究，以确定婴儿是否符合清洁间歇导尿的客观标准。

DESCRIPTION (provided by applicant): The Management of Myelomeningocele Study (MOMS) is a multi-center unblinded randomized clinical trial of 200 patients that is underway at three clinical centers, the University of California- San Francisco, The Children's Hospital of Philadelphia, and Vanderbilt University Medical Center, and a data coordinating center. The primary objective of the trial is to determine whether intrauterine repair of fetal MMC at 19 0 to 25 6 weeks gestation improves outcome, as measured by 1) death or the need for ventricular decompressive shunting by one year of life, and 2) a composite neurologic function score at 30 months corrected age. Only a small percentage of children with spina bifida are born with a normal innervation of their bladder and sphincter muscles, with urologic sequelae that are life-long. The effect of prenatal surgery for MMC on subsequent urolgic function is unknown, but vitally important to determine. This proposal is for a supplement to the MOMS trial to initiate a more rigorous urologic follow-up of the infants in the trial. It is anticipated that 120 infants will receive renal sonography, video urodynamics and urinalysis, culture and sensitivity at three time points during the study before neonatal discharge following delivery, at 12 months, and at30 months corrected age. The aim of the supplement is to determine whether in utero treatment of open MMC affects the outcome with respect to urinary tract infection, and the need for intermittent caterterization. A committee of three independent pediatric urologists will review medical records and imaging studies to determine whether infants meet objective criteria for clean intermittent catheterization.