The proposed project is an additional component to be submitted with part of the Oregon Spina Bifida Registry Project- Component B. This project, titled, Urologic Protocol for Infants with Myelomeningocele, is responsive to Component C. Component C involves the use of a standardized bladder management protocol for children with neurogenic bladder dysfunction secondary to Spina Bifida. Bladder management is of paramount importance in maintaining normal renal function and protecting the kidney from injury due to infection or high intravesical pressure. Active bladder management consisting of a program of clean intermittent catheterization and medical management of neurogenic bladder dysfunction has been associated with lower risk of hydronephrosis, renal scarring, and the need for major reconstructive surgery, such as bladder augmentation. The primary goal of the protocol is to prevent renal injury as will be shown with the preservation of renal function measured by serum Cr and GFR, lack of renal scarring as demonstrated by DMSA renal scintigraphy, and normal growth of the kidneys with the absence of hydronephrosis demonstrated by serial renal ultrasonography. The Oregon Spina Bifida Bifida Registry Project has been a funded site of the NSBPR since its inception since 2008. Oregon has enrolled approximately 99% of eligible patients into the registry. As a study center, children at our institution would be enrolled as infants and managed over a 5-year period following the proposed protocol. Given the high enrollment rate so far with the Oregon Spina Bifida registry and that the proposed management protocol is very similar to the current standard clinical management it is expected that most parents would be willing to enroll their child. We meet the criteria for eligibility with an average of 5 newborns born per year from 2011-2013 with Spina Bifida and managed at our center (16 patients total). Data will be entered into the national registry as patients are managed according to the protocol. The protocol consists of standard medical care and should present minimal risk to enrolled patients. The patients will be carefully monitored for compliance with the program, adherence to the protocol schedule, and safety. At the end of 5 years renal function will be evaluated and compared to baseline findings from studies obtained during infancy.

Public Health Relevance

The use of a Urologic Protocol for the Preservation of renal Function (UPPF) would standardize bladder management for newborns with Spina Bifida. The hypothesis is that early optimal management of the bladder will prevent kidney and bladder damage in these young patients. This could decrease the risk if chronic kidney disease and hypertension in patients with Spina Bifida.

Agency
National Institute of Health (NIH)
Institute
Centers for Disease Control and Prevention (NCBDD)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DD001058-03
Application #
9108700
Study Section
Special Emphasis Panel (ZDD1)
Project Start
2014-09-01
Project End
2019-08-31
Budget Start
2016-09-01
Budget End
2017-08-31
Support Year
3
Fiscal Year
2016
Total Cost
Indirect Cost
Name
Oregon Health and Science University
Department
Type
Organized Research Units
DUNS #
096997515
City
Portland
State
OR
Country
United States
Zip Code
97239