Management of Myelomeningocele Study

Childrens Hospital Of Philadelphia, Philadelphia PA

Investigators

Linked publications & trials

Abstract

[unreadable] 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. [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 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. [unreadable] [unreadable]