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

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

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.

Study Overview

• Status: Completed
• Conditions: Intracranial Thrombosis
• Intervention / Treatment: Procedure: Ultrasound

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 4 weeks (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Manohar Shroff, The Hospital for Sick Children

Publications and helpful links

Helpful Links

• Link to final publication abstract

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (ACTUAL): March 1, 2008
• Study Completion (ACTUAL): March 1, 2008

Study Registration Dates

• First Submitted: November 8, 2007
• First Submitted That Met QC Criteria: November 8, 2007
• First Posted (ESTIMATE): November 9, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): May 20, 2015
• Last Update Submitted That Met QC Criteria: May 19, 2015
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Pediatrics; Intracranial Thrombosis; Cerebral Sinovenous Thrombosis; Cranial Ultrasound
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Embolism and Thrombosis; Intracranial Embolism and Thrombosis; Thromboembolism; Thrombosis; Intracranial Thrombosis
• Other Study ID Numbers: 1000010745