This is a prospective, single-arm non-randomized interventional study of fetuses to assess the efficacy and safety of fetal embolization of VOGM. Subjects will receive a one-time study intervention of fetal embolization, at or after 34 weeks of gestation. After delivery, neurological assessments will be performed every 6 months for 2 years (adjusted for gestational age). Data will be compared to historical cohorts.
The study involves a single fetal intervention of maternal transuterine, fetal transcranial torcular puncture and median prosencephalic vein embolization for fetuses with vein of Galen malformations (VOGM) with a falcine sinus (FS) width of \>= 7 mm (study population). Detachable platinum coils (Target XL and XXL Detachable Coil, Stryker Neurovascular) will be used to pack the prosencephalic varix. This procedure will take place in an OR at Boston Children's Hospital. Data regarding pre-delivery, delivery and post-delivery status will be collected until the subject is discharged from the hospital. After delivery, neurological assessments will be performed on the child every 6 months for 2 years (adjusted for gestational age). Data will be compared to historical cohorts.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The study involves a single fetal intervention of maternal transuterine, fetal transcranial torcular puncture and median prosencephalic vein embolization. Detachable platinum coils (Target XL and XXL Detachable Coil, Stryker Neurovascular) will be used to pack the prosencephalic varix.
Boston Children's Hospital
Boston, Massachusetts, United States
Efficacy of fetal embolization for patients with vein of Galen malformations
Primary outcome/endpoint: mortality measured from birth to day 30 of life.
Time frame: Birth to day 30 of life
Safety of fetal embolization of patients with vein of Galen malformations
Safety outcomes/endpoint: the incidence of the following serious adverse events (SAEs) from Day 0 (the day of fetal intervention) till birth, as measured by number of events experienced across the number of participants enrolled: 1. Fetal intraparenchymal hemorrhage with mass effect, likely related to the procedure 2. Fetal territorial ischemic infarct, likely related to the procedure 3. Procedure-related fetal hemorrhage, either intracranial or extracranial, requiring transfusion 4. Maternal hemorrhage requiring blood transfusion 5. Procedure-related placental injury requiring urgent Caesarian section
Time frame: Day of fetal intervention to 24 months of age
Brain parenchymal injury
The incidence of brain parenchymal injury on the first postnatal scan will be collected and compared to a historical cohort that did not undergo fetal intervention.
Time frame: Birth to first postnatal scan
Neurodevelopmental milestones at 6 months
A neurological assessment will be performed at 6 months adjusted gestational age using Vineland Adaptive Behavior Scales and the Receptive-Expressive Emergent Language Test. Scores for enrolled participants will be compared to scores from a historical cohort at a similar age.
Time frame: Birth through 6 months
Neurodevelopmental milestones 6 months through 24 months
Neurological assessments will be performed from 6 months adjusted gestational age to 24 months adjusted gestational age using Vineland Adaptive Behavior Scales and the Receptive-Expressive Emergent Language Test, Child Behavior Checklist, DAYC-2 cognitive assessment, and the Bayley examination (if seen in person). Scores for enrolled participants will be compared to scores from a historical cohort at a similar age.
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Time frame: 6 months through 24 months