Purpose of this Study
We are doing this study to collect information about our state-of-the-art methods to care for the bladder and kidneys of babies born with spina bifida. We want to compare the results of these methods with other hospitals around the country that are following the same guidelines to protect the bladder and kidney health of infants with spina bifida. We and the other centers following these guidelines will regularly evaluate the outcomes of this care and modify the methods accordingly.
Who Can Participate?
Eligibility
Infants who are born with the myelomeningocele (open) form of spina bifida during the first 3 months of life.
For more information, contact the study team at <a href= "mailto: denise.lech@duke.edu">denise.lech@duke.edu.</a>
For more information, contact the study team at <a href= "mailto: denise.lech@duke.edu">denise.lech@duke.edu.</a>
Age Range
0
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to enroll your child in this study, we will treat their bladder and kidneys in the same manner that we treat all newborns with spina bifida. For those who enroll, we will compare their outcomes (without any identifying information) with children treated at other medical centers to determine what is the best way to manage bladders and kidneys. We will keep tabs on your child's health and progress for up to 10 years.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
Urologic Management to Preserve Renal Function Protocol - Duke Project
Study Website
Principal Investigator
John
Wiener
Protocol Number
PRO00061849
NCT ID
NA
Phase
N/A
Enrollment Status
Open to Enrollment