Research Approaches to Improve the Care and Outcomes of People Living with Spina Bifida- Component C

NIH RePORTER · ALLCDC · U01 · $25,000 · view on reporter.nih.gov ↗

Abstract

Project Summary- Component C The urologic management of the newborn and young child with spina bifida is currently based on dogma and “expert opinion”, a significant limitation when it comes to determining “best practice” standards. It is accepted that >90% of newborns with spina bifida have normal kidney function and normal appearing kidneys. If unattended; approximately 50% encounter some degree of kidney compromise by the age of 5 years. There is a need for standardization of the urologic care of the newborn and young child with spina bifida using a management protocol that will protect kidney function and control hostile bladder function. The proposed Urologic Management to Preserve Initial Renal Function Protocol for Young Children with Spina Bifida (UMPIRE Protocol) from birth through the age of 10 years provides the opportunity to develop an evidenced- based model for the care of children with a neurogenic bladder secondary to spina bifida. The desired outcome of the protocol is to preserve and protect normal kidney function while utilizing resources in a cost efficient fashion. The previous funding cycle provided the framework for the UMPIRE protocol and described the treatment regimen for the child with spina bifida from birth through the first 5 years of life. Continuing to follow these children for the next 5 years, until age 10, will be critically important in validating the success of the protocol as written. The University of Alabama at Birmingham (UAB) has enrolled 35 patients in the UMPIRE project which represents 100% of patients born with spina bifida at our site. Throughout the duration of the protocol, testing of bladder function is undertaken along with assessment of kidney function and appearance. Data is collected on an ongoing basis that is sent electronically to the CDC for analysis. Changes to the protocol may occur when it becomes apparent changes would improve kidney health. A successful outcome has universal appeal and the potential to standardize the care of children with neurogenic bladder dysfunction across all neuropathic disorders of which spina bifida makes up the greatest percent based on etiology. This becomes exceedingly important not only for the large centers caring for children with a neurogenically abnormal bladder but also for smaller centers that don’t have the patient volume that would allow them to make any reasonable predictions on management based on their own data. In addition to continuing to provide data points on the 35 patients currently enrolled, UAB also intends to continue patient enrollment of all newborns born with spina bifida at our site. Finally, UAB has proposed a project to determine the incidence of bladder hostility in patients enrolled in the National Spina Bifida Patient Registry prior to the beginning of the UMPIRE protocol and compare that with patients enrolled in the UMPIRE.

Key facts

NIH application ID
11142939
Project number
6U01DD001236-05M001
Recipient
UNIVERSITY OF ALABAMA AT BIRMINGHAM
Principal Investigator
David B Joseph
Activity code
U01
Funding institute
ALLCDC
Fiscal year
2023
Award amount
$25,000
Award type
6
Project period
2019-09-01 → 2025-08-31