Sonographic parameters in neonatal Vein of Galen Malformation and their significance as prognostic factors with the inclusion of contrast-enhanced transfontanellar ultrasound

Sonographic parameters in neonatal Vein of Galen Malformation and their significance as prognostic factors with the inclusion of contrast-enhanced transfontanellar ultrasound - SPV-Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030052

Enrollment

Registered

2022-09-06

Start date

2022-07-01

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Q28.28

Interventions

Group 1: Prospective, noninterventional observational study in neonates with Vein of Galen Malformation. Data collection by ultrasound, Doppler/duplex sonography, and contrast-enhanced sonography at f

Eligibility

Sex/Gender

All

Age

No minimum to 1 Months

Inclusion criteria

Inclusion criteria: neonatal Vein of Galen Malformation

Exclusion criteria

Exclusion criteria: Other AV malformation Other malformation or chromosomal disorder affecting prognosis Inpatient admission after the 28th day of life

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the short-term outcome is the cerebral damage assessed by MRI or cranial ultrasonography during the course of hospitalization. The primary endpoint of the long-term outcome is the Parent Report of Children's Abilities Revised (PARCAR) Questionnaire at 23-27 months of age.	—

Secondary

Measure	Time frame
Data on each individual patient are collected at different points in time: 1. during the first inpatient stay for interventional or palliative therapy at Sana Kliniken Duisburg. 2. during subsequent stays at Sana Kliniken Duisburg. 3. during the annual response to a questionnaire on the boundary stones of development. 4. when answering the standardized questionnaire "Parent Report of Children's Abilities Revised" (PARCAR) Questionnaire for the assessment of children's abilities at the age of 23-27 months corrected. 5. neuropsychological testing (WIPPSI-IV) at the age of 5 years. The following endpoints are scheduled for analysis: Short-term outcome parameters: - Imaging-visible cerebral damage from the first MRI to the MRI in the second inpatient stay; recorded by means of a structured reporting system if necessary derivation of a scoring system. - Death/severe cerebral damage on imaging - Bicêtre score before elective intubation for MRI or for embolization, respectively - Organ involvement during the course - Procedural complications of neurointerventional therapy during first inpatient stay - Doppler parameters such as aortic steal, Doppler indices of brain-supplying arteries, flow profile in superior sagittal sinus. Long-term outcome parameters collected at 2 years of age: - Results of the PARCAR parent questionnaire with output of developmental percentiles. - Death/severe multiple disabilities. - Neurological deficits: Hemiparesis, infantile cerebral palsy, motor development delay, i.e., failure to reach or delay in reaching milestones (turning, sitting, walking), language development delay/disorder, shunt-supplied hydrocephalus, epilepsy, visual impairment, hearing impairment - severe procedural complications of neurointerventional therapy: parenchymal hemorrhage, ischemia/infarction, intraventricular hemorrhage with creation of EVD, venous occlusion, arterial dissection or spasm with cerebral insult Long-term outcome parameters collected at	—

Measure

Time frame

Data on each individual patient are collected at different points in time: 1. during the first inpatient stay for interventional or palliative therapy at Sana Kliniken Duisburg. 2. during subsequent stays at Sana Kliniken Duisburg. 3. during the annual response to a questionnaire on the boundary stones of development. 4. when answering the standardized questionnaire "Parent Report of Children's Abilities Revised" (PARCAR) Questionnaire for the assessment of children's abilities at the age of 23-27 months corrected. 5. neuropsychological testing (WIPPSI-IV) at the age of 5 years. The following endpoints are scheduled for analysis: Short-term outcome parameters: - Imaging-visible cerebral damage from the first MRI to the MRI in the second inpatient stay; recorded by means of a structured reporting system if necessary derivation of a scoring system. - Death/severe cerebral damage on imaging - Bicêtre score before elective intubation for MRI or for embolization, respectively - Organ involvement during the course - Procedural complications of neurointerventional therapy during first inpatient stay - Doppler parameters such as aortic steal, Doppler indices of brain-supplying arteries, flow profile in superior sagittal sinus. Long-term outcome parameters collected at 2 years of age: - Results of the PARCAR parent questionnaire with output of developmental percentiles. - Death/severe multiple disabilities. - Neurological deficits: Hemiparesis, infantile cerebral palsy, motor development delay, i.e., failure to reach or delay in reaching milestones (turning, sitting, walking), language development delay/disorder, shunt-supplied hydrocephalus, epilepsy, visual impairment, hearing impairment - severe procedural complications of neurointerventional therapy: parenchymal hemorrhage, ischemia/infarction, intraventricular hemorrhage with creation of EVD, venous occlusion, arterial dissection or spasm with cerebral insult Long-term outcome parameters collected at

—

Countries

Germany

Contacts

Public ContactSimone Schwarz

Klinik für Kinder- und JugendmedizinSana Kliniken Duisburg GmbH

simone.schwarz@sana.de02037333296

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026