Myelomeningocele Repair Randomized Trial (U01-HD41665)

George Washington University, Washington DC

Investigators

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Abstract

[unreadable] DESCRIPTION (provided by applicant): The Management of Myelomeningocele Study (MOMS) is a multi-center unblended 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 the George Washington University Biostatistics Center as the Data and Study Coordinating Center. The primary objective of the trial is to determine whether intrauterine repair of fetal myelomeningocele at 190 to 256 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. [unreadable] [unreadable] 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 myelomeningocele on subsequent urologic 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 30 months corrected age. The aim of the supplement is to determine whether in utero treatment of open myelomeningocele affects the outcome with respect to urinary tract infection, and the need for intermittent catheterization. A committee of independent pediatric urologists will review medical records and imaging studies to determine whether infants meet objective criteria for clean intermittent catheterization. [unreadable] [unreadable] The George Washington University Biostatistics Center will serve as the Data and Study Coordinating Center for this supplement. We will collaborate on study design, revise the protocol and manual of operations, prepare case report forms, arrange publicity, update and maintain the data management system and study internal and external internet sites. We will continue to serve as the central screening and referral site, and we will coordinate the centralized outcome review, as well as the long term follow-up visits conducted at the three centers. [unreadable] [unreadable]