Modern Ultrasound Techniques in the Evaluation of Cerebral Venous Sinuses in Neonates

This study has been completed.
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00555932
First received: November 8, 2007
Last updated: May 22, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention
Intracranial Thrombosis
Procedure: Ultrasound

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 58
Study Start Date: May 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Ultrasound
All the studies will be performed with the portable ultrasound machine used on a regular basis in the neonatal care unit.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00555932

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Manohar Shroff The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Manohar Shroff/Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00555932     History of Changes
Other Study ID Numbers: 1000010745
Study First Received: November 8, 2007
Last Updated: May 22, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Intracranial Thrombosis
Cerebral Sinovenous Thrombosis
Pediatrics
Cranial Ultrasound

Additional relevant MeSH terms:
Intracranial Thrombosis
Thrombosis
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Embolism and Thrombosis
Intracranial Embolism and Thrombosis
Nervous System Diseases
Thromboembolism
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014