Spina Bifida (SB) is a congenital neurologic defect that can affect multiple organ systems in the fetus, growing child, and adult. SB results from incomplete neural tube closure and protrusion of spinal membranes and nerves by the end of the first month of pregnancy. Myelomeningocele is the most severe form of SB in which the spinal cord and nerves come through the spinal defect and are exposed on the surface. This results in a wide range of impairments that affect many body systems. In urology specifically, variation in care between centers is recognized beginning at birth and myelomeningocele closure. It is well known that over 90% of children with myelomeningocele have neurogenic bladder, and if untreated, the sequelae of neurogenic bladder may result in renal failure over time. Urologic care in infants may be proactive to identify and initiate early treatment of hostil bladders or may be more observational with initiation of therapy only when kidneys begin to suffer insult. The National SB Patient Registry (NSBPR) was initiated in 2008 by the Centers for Disease Control and Prevention (CDC) and now has collected data on over 4000 patients from 19 SB clinics across the nation. This pilot project has demonstrated the ability of multiple SB centers to work collaboratively to enroll SB patient and collect pertinent patient data in an effor to improve care of SB patients collectively.(2) The next logical step of the registry is to examine critical issues in the care of SB patients by application of this model of multi-center collaboratie data collection. The CDC recently enlisted experts in pediatric urology and nephrology to develop a protocol for prospective standardized urologic management of newborns with myelomeningocele (Urologic Protocol for the Protection of Renal Function - UPPF) to be conducted over the first five years of life. The number of affected newborns across the U.S. is too small to make feasible a randomized, prospective controlled trial between proactive and observational management, but regular evaluation of a standardized protocol should allow determinations to be made about the necessity and regularity of interventions, such as imaging, urodynamic testing, and laboratory tests, to preserve renal function in the growing child. This project proposes to test the feasibility of implementation of the UPPF at Duke, assess the long term urologic outcomes of renal and bladder function in children following the UPPF over the first five years of life, and determine the necessity of following all components of the UPPF during the five years to optimally achieve the goal of preservation of renal function as a positive health outcome.
The CDC recently enlisted experts in pediatric urology and nephrology to develop a protocol for prospective standardized urologic management of newborns with myelomeningocele (Urologic Protocol for the Protection of Renal Function - UPPF) to be conducted over the first five years of life. The number of affected newborns across the U.S. is too small to make feasible a randomized, prospective controlled trial between proactive and observational management, but regular evaluation of a standardized protocol should allow determinations to be made about the necessity and regularity of interventions, such as imaging, urodynamic testing, and laboratory tests, to preserve renal function in the growing child. This application proposes to recruit newborns with myelomeningocele treated at Duke and follow them for five years for data collection and analysis related to the UPPF.
