Myelomeningocele, Myeloschisis, Spina Bifida; Fetus
Conditions
Keywords
Fetoscopic fetal intervention, Human umbilical cord, NEOX Cord 1K
Brief summary
The objective is to test the efficacy of a laparotomy-assisted fetoscopic surgical approach to cover spina bifida spinal cord developmental defects using cryopreserved human umbilical cords (NEOX Cord 1K®) as a meningeal and skin patch.
Interventions
DEVICENEOX Cord 1K applied fetoscopically
Under general anesthesia and tocolysis, in-utero repair begins with a laparotomy that is followed by exteriorization of the uterus. The fetus is then positioned by external cephalic version. Uterine entry will be accessed using 3 cannulas, followed by heated-humidified carbon dioxide insufflation for visualization. Then, fetoscopically the placode will be examined and dissected. The lesion will be repaired using NEOX Cord 1K® (HUC) for closure of the first layer over the neural placode. Primary closure of the skin will then occur, or NEOX Cord 1K® (human umbilical cord) will be used for skin closure at the discretion of the Pediatric Neurosurgeon. Finally, the laparotomy site will be sutured in multiple layers.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Maternal Inclusion Criteria: 1. Singleton pregnancy 2. Gestational age at screening is 19 to 25 5/7 weeks and gestational age at surgery is 22 to 25 6/7 weeks 3. Maternal age: 18 years and older 4. Body mass index ≤45 kg/m2 (pre-pregnancy) 5. No preterm birth risk factors (short cervix \<20 mm or a history of previous preterm delivery) 6. No previous uterine incision in the active uterine segment 7. Willing to undergo an open fetal repair if the fetoscopic approach is unsuccessful Fetal Inclusion Criteria: 1. Spina bifida defect between T1 to S1 vertebral levels 2. Chiari II malformation 3. No evidence of kyphosis (curved spine) 4. No major life-threatening fetal anomaly unrelated to spina bifida 5. Normal karyotype, or a normal chromosomal microarray analysis (CMA), or a CMA with variants of unknown significance \[fluorescence in situ hybridization (FISH) acceptable if ≥ 24 weeks\].
Exclusion criteria
Maternal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants that can ambulate independently by walking at least 10 steps | 30-36 months after delivery |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with lower extremity motor and sensory levels exceeding the anatomical level of the lesion by ≥ 2 segments | 30-36 months after delivery |
Countries
United States
Contacts
Primary ContactRamesha Papanna, MD, MPH
Backup ContactStephanie W Conaway, BSN
Outcome results
None listed