About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Autologous umbilical cord patch