Modern Ultrasound Techniques in the Evaluation of Cerebral Venous Sinuses in Neonates
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Utility of Modern Ultrasound Techniques in the Evaluation of Cerebral Venous Sinuses in Neonates|
- To prospectively evaluate the feasibility of visualization of normal dural venous sinuses, their patency, and normal variations with ultrasound in newborn children (preterm & term), using cross sectional imaging (MRI and/or CT) as reference standards. [ Time Frame: Within 10 hours of the MRI scan ] [ Designated as safety issue: No ]
- The ability of doppler ultrasound to evaluate flow velocities in all dural venous sinuses that will be evaluated in this study. [ Time Frame: Within 10 hours of MRI ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
The research head ultrasound (HUS) will be performed at the bedside in the Neonatal Unit. The ultrasound examination will be performed within 10 hours time window of the MR and or CT study.
All the studies will be performed with the portable ultrasound machine used on a regular basis in the neonatal care unit.
Cranial ultrasound is an established technique for evaluation of the neonatal brain. However its role in the evaluation of cerebral dural venous sinuses in neonates has not been established. It is very important to evaluate the cerebral dural venous sinuses, as cerebral sinovenous thrombosis (CSVT) is an increasingly recognized condition in neonates.
There is an obvious clinical need for systematically evaluating the role of ultrasound with doppler in the evaluation of cerebral venous sinuses. Advances in diagnostic imaging have led to rapid clinical implementation of newer technologies like MR and CT for evaluation of venous sinuses. However technological advances in older imaging methods like ultrasound which have advantages of being non-invasive and being performed at the bedside have not been evaluated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555932
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Manohar Shroff||The Hospital for Sick Children|