Intracranial Thrombosis Clinical Trial
Official title:
Utility of Modern Ultrasound Techniques in the Evaluation of Cerebral Venous Sinuses in Neonates
Verified date | May 2008 |
Source | The Hospital for Sick Children |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
Our overall aim is to examine if ultrasound is as accurate as MRI and/or CT in the evaluation of dural venous sinuses. We hypothesize that sonography will be accurate (accuracy >80%) for diagnosing specific anatomic findings of dural venous sinuses.
Status | Completed |
Enrollment | 58 |
Est. completion date | March 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 28 Days |
Eligibility |
Inclusion Criteria: 1. All neonates (up to 28 days old) and preterm infants, hospitalized at HSC who need clinically indicated brain MR and MRV as part of their diagnostic workup. Clinical indications for MR could include birth asphyxia, seizures, irritability, lethargy, abnormal neurological examination, etc. 2. Neonates and preterm infants & who are clinically considered stable to undergo the ultrasound study. This will be determined at the bedside by the neonatology team in attendance. 3. Where consent is available from parents. 4. Only neonates and preterm infants who have undergone a technically adequate MRI study which includes vascular MR venography sequences or CT with contrast will be included. Assessments for technically adequacy will be made by the technologist or the supervising radiologist, as per clinical protocols currently used in the department of diagnostic imaging. This will be determined by referring to notes made on the request form and also by direct communication between the supervising radiologist and team members obtaining consent. Exclusion Criteria: 1. Vital signs will be monitored in the usual manner by the nurses in attendance in the neonatal unit. If the neonate is unstable, an ultrasound study will not be done. 2. If after starting the ultrasound, any signs of instability are noted during the study, the ultrasound study will discontinued. 3. If consent from parent or guardian is not available, the research ultrasound study will not be done. 4. If the ultrasound cannot be done within a 10 hours window of the CT or MR study (due to technical problems with machine or skilled personnel not being available). 5. Neonates & preterm infants who have undergone technically inadequate MR and/or CT will not be included. Such technical inadequacy will be determined by referring to notes made by the technologist on the request form and by direct communication with the supervising radiologist. 6. Neonates & preterm infants undergoing repeat CT and/or MRs will be excluded from the study. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Canada | The Hospital for Sick Children | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Within 10 hours of the MRI scan | No | |
Secondary | The ability of doppler ultrasound to evaluate flow velocities in all dural venous sinuses that will be evaluated in this study. | Within 10 hours of MRI | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04139486 -
adaptatiVe Endovascular Strategy to the CloT MRI in Large Intracranial Vessel Occlusion
|
N/A |