title: Design and Methodological Considerations of the Centers for Disease Control and Prevention Urologic and Renal Protocol for the Newborn and Young Child with Spina Bifida.
abstract: Care of children with spina bifida has significantly advanced in the last half century, resulting in gains in longevity and quality of life for affected children and caregivers. Bladder dysfunction is the norm in patients with spina bifida and may result in infection, renal scarring and chronic kidney disease. However, the optimal urological management for spina bifida related bladder dysfunction is unknown.
  
  
  
  In 2012 the Centers for Disease Control and Prevention convened a working group composed of pediatric urologists, nephrologists, epidemiologists, methodologists, community advocates and Centers for Disease Control and Prevention personnel to develop a protocol to optimize urological care of children with spina bifida from the newborn period through age 5 years.
  
  
  
  An iterative quality improvement protocol was selected. In this model participating institutions agree to prospectively treat all newborns with spina bifida using a single consensus based protocol. During the 5-year study period outcomes will be routinely assessed and the protocol adjusted as needed to optimize patient and process outcomes. Primary study outcomes include urinary tract infections, renal scarring, renal function and bladder characteristics. The protocol specifies the timing and use of testing (eg ultrasonography, urodynamics) and interventions (eg intermittent catheterization, prophylactic antibiotics, antimuscarinic medications). Starting in 2014 the Centers for Disease Control and Prevention began funding 9 study sites to implement and evaluate the protocol.
  
  
  
  The Centers for Disease Control and Prevention Urologic and Renal Protocol for the Newborn and Young Child with Spina Bifida began accruing patients in 2015. Assessment in the first 5 years will focus on urinary tract infections, renal function, renal scarring and clinical process improvements.
authors.affiliation: Division of Urology, Duke University Medical Center, Durham, North Carolina. Electronic address: jonathan.routh@duke.edu.
authors.forename: Jonathan C
authors.initials: JC
authors.lastname: Routh
authors.affiliation: Division of Urology, Lurie Children's Hospital of Chicago, Chicago, Illinois.
authors.forename: Earl Y
authors.initials: EY
authors.lastname: Cheng
authors.affiliation: Department of Urology, Oregon Health Sciences University, Portland, Oregon.
authors.forename: J Christopher
authors.initials: JC
authors.lastname: Austin
authors.affiliation: Division of Nephrology, Boston Children's Hospital, Boston, Massachusetts.
authors.forename: Michelle A
authors.initials: MA
authors.lastname: Baum
authors.affiliation: Department of Urology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Patricio C
authors.initials: PC
authors.lastname: Gargollo
authors.affiliation: Department of Urology, Seattle Children's Hospital, Seattle, Washington.
authors.forename: Richard W
authors.initials: RW
authors.lastname: Grady
authors.affiliation: National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Adrienne R
authors.initials: AR
authors.lastname: Herron
authors.affiliation: Division of Urology, Children's Hospital Los Angeles, Los Angeles, California.
authors.forename: Steven S
authors.initials: SS
authors.lastname: Kim
authors.affiliation: Department of Urology, Riley Hospital for Children, Indianapolis, Indiana.
authors.forename: Shelly J
authors.initials: SJ
authors.lastname: King
authors.affiliation: Division of Urology, Texas Children's Hospital/Baylor College of Medicine, Houston, Texas.
authors.forename: Chester J
authors.initials: CJ
authors.lastname: Koh
authors.affiliation: National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Pangaja
authors.initials: P
authors.lastname: Paramsothy
authors.affiliation: Spina Bifida Association, Arlington, Virginia.
authors.forename: Lisa
authors.initials: L
authors.lastname: Raman
authors.affiliation: Division of Pediatric Pulmonary Medicine, Children's Hospital of Richmond at Virginia Commonwealth University, Richmond, Virginia.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Schechter
authors.affiliation: Division of General Pediatrics, Children's Hospital Los Angeles, Los Angeles, California.
authors.forename: Kathryn A
authors.initials: KA
authors.lastname: Smith
authors.affiliation: Division of Pediatric Urology, Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, Tennessee.
authors.forename: Stacy T
authors.initials: ST
authors.lastname: Tanaka
authors.affiliation: National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Judy K
authors.initials: JK
authors.lastname: Thibadeau
authors.affiliation: Division of Developmental Medicine, Seattle Children's Hospital, Seattle, Washington.
authors.forename: William O
authors.initials: WO
authors.lastname: Walker
authors.affiliation: Division of Urology, Primary Children's Hospital, Salt Lake City, Utah.
authors.forename: M Chad
authors.initials: MC
authors.lastname: Wallis
authors.affiliation: Division of Urology, Duke University Medical Center, Durham, North Carolina.
authors.forename: John S
authors.initials: JS
authors.lastname: Wiener
authors.affiliation: Department of Urology, University of Alabama-Birmingham, Birmingham, Alabama.
authors.forename: David B
authors.initials: DB
authors.lastname: Joseph
mesh_terms: D002487:Centers for Disease Control and Prevention, U.S.; D002675:Child, Preschool; D002985:Clinical Protocols / Q000592:standards*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D016135:Spinal Dysraphism / Q000150:complications; D014481:United States; D001750:Urinary Bladder, Neurogenic / Q000209:etiology / Q000628:therapy*
keywords: neurogenic; pediatrics; spinal dysraphism; urinary bladder; urology