Ignite Creation Date:
2025-12-18 @ 8:28 AM
Ignite Modification Date:
2025-12-23 @ 6:58 PM
Study NCT ID:
NCT05648812
Status:
None
Last Update Posted:
2024-10-15 00:00:00
First Post:
2022-12-05 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neonatal Brain Ultrasound With CEUS and Elastography
Sponsor:
None
Organization:
Study Overview
Official Title:
Contrast Enhanced Ultrasound and Elastography of the Neonatal Brain
Status:
None
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
SonoVue (sulphur hexafluoride) is a contrast agent composed of micro bubbles. It increases echogenicity of the ultrasound thus enhancing the visualisation of vessels and giving better insights into tissue perfusion. The use of sulphur hexafluoride has been approved by FDA and it has been in off-label use in Europe for years. SonoVue is thought to be especially useful for children, because it can enhance the diagnostic capabilities of ultrasound and the examination can be performed without radiation or sedation.
Elastography is a method to investigate the elasticity of a tissue by tracking the shear waves generated by the ultrasound beam. Also this method has been used in Europe and America for years.
The aim of our study is to examine cerebral hemodynamics in neonates using ultrasound of the brain, contrast enhanced ultrasound (CEUS) and ultrasound-guided shear-wave elastography (US-SWE). We aim to recruit four groups of infants: those with no suspected diseases affecting brain perfusion on the first days after birth and infants with either asphyctic injury, stroke or other diseases affecting central nervous system. Total recruitment for different groups is 100 infants in total, during this first study phase. The recruitment period will be up to seven years if needed.
The injections of SonoVue will be administered through pre-existing venous cannulas. The first examination after brain injury will be done as soon as the parental consent has been given. The ultrasound examination altogether is estimated to take about 20 minutes per day. Safety monitoring period is conducted after the injection. The studies will be repeated 0-4 times according to the approval of the caretakers of the child and the disease the child is affected by. CEUS data will be analysed with proper software. US-SWE will be measured repeatedly on both brain hemispheres and on different areas to validate the measurements.
Elastography is a method to investigate the elasticity of a tissue by tracking the shear waves generated by the ultrasound beam. Also this method has been used in Europe and America for years.
The aim of our study is to examine cerebral hemodynamics in neonates using ultrasound of the brain, contrast enhanced ultrasound (CEUS) and ultrasound-guided shear-wave elastography (US-SWE). We aim to recruit four groups of infants: those with no suspected diseases affecting brain perfusion on the first days after birth and infants with either asphyctic injury, stroke or other diseases affecting central nervous system. Total recruitment for different groups is 100 infants in total, during this first study phase. The recruitment period will be up to seven years if needed.
The injections of SonoVue will be administered through pre-existing venous cannulas. The first examination after brain injury will be done as soon as the parental consent has been given. The ultrasound examination altogether is estimated to take about 20 minutes per day. Safety monitoring period is conducted after the injection. The studies will be repeated 0-4 times according to the approval of the caretakers of the child and the disease the child is affected by. CEUS data will be analysed with proper software. US-SWE will be measured repeatedly on both brain hemispheres and on different areas to validate the measurements.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: