Spina Bifida
Conditions
Keywords
open neural tube defects, autologous umbilical cord patch, myelomeningocele, myeloschisis
Brief summary
The purpose of this study is to determine the impact of an autologous umbilical cord patch for dural closure on the repair of open neural tube defect. The outcomes will evaluate successful defect closure, creation of a more capacious spinal canal, and reduction in inflammatory tissue response versus historical controls.
Interventions
PROCEDUREAutologous umbilical cord patch
Surgery will occur from birth to 24 hours of age. The autologous umbilical cord patch is harvested at time of delivery and immediately processed in a sterile setting in order to create a dural patch as a spinal cord cover to close the developmental defect within a few hours after birth.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Hours
Healthy volunteers
No
Inclusion criteria
* Neonates born with prenatal diagnosis of open neural tube defect (myelomeningocele or myeloschisis) * Resident of the United States * Provision of signed and dated informed consent form * Stated willingness by legally authorized representative (LAR) to comply with all study procedures and availability for the duration of the study * Maternal age 18 years and older * Mother is English or Spanish Speaking
Exclusion criteria
* Sepsis or signs of infection of the neonate * Febrile or other acute illness of the neonate at time of delivery * Major congenital anomaly unrelated to spina bifida that may impact safety of neonate for surgery * Evidence of intra-amniotic or maternal infection related to pregnancy at time of delivery * Maternal use of steroid therapy during pregnancy or neonate use of steroid therapy,except for lung maturity indications * Vaginal delivery * Patch closure of dura is deemed unnecessary * Umbilical cord abnormality * Insufficient autologous cord tissue or patch * Autologous umbilical cord patch that does not meet laboratory safety standards per standard operating procedure (SOP) * Treatment with an investigational drug or other intervention that would influence morbidity or mortality
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants that have wound dehiscence | one-month post-op |
| Number of participants that have Cerebrospinal fluid (CSF) leakage | one-month post-op |
| Number of participants that have CSF leakage | 1-year post-op. |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants that present with tethered cord syndrome | one-month post-op,12-months post-op, 30-months post-op, and 60-months post-op |
| Number of participants that had a change in level of neurological function as assessed by the American Spinal Injury Association Impairment Scale (ASIA) | baseline, one-month post-op,12-months post-op |
Countries
United States
Contacts
Primary ContactStephen Fletcher, DO
Backup ContactCaroline Doughty
Outcome results
None listed