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CompletedNCT00555932Updated May 20, 2015

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

An interventional study of Ultrasound in Intracranial Thrombosis, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 1 Hour to 28 Days. Per ClinicalTrials.gov, last updated 2015-05-20.

Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Non-randomized
Ages
1 Hour to 28 Days
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Intracranial Thrombosis

Keywords

  • Intracranial Thrombosis
  • Cerebral Sinovenous Thrombosis
  • Pediatrics
  • Cranial Ultrasound
03

In context

Intracranial Thrombosis

26 studies on the registry are indexed under Intracranial Thrombosis; 9 are open to participants now.

This study's enrollment of 58 is below the median of 192 across 12 interventional studies indexed under Intracranial Thrombosis.

Browse Intracranial Thrombosis studies →

Lead sponsor

The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Hour to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
58 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureUltrasound

    All the studies will be performed with the portable ultrasound machine used on a regular basis in the neonatal care unit.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

1 site
  • The Hospital for Sick Children
    Toronto, Ontario M5G 1X8, Canada
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00555932
Lead sponsor
The Hospital for Sick Children
Responsible party
Manohar Shroff (Chief, Diagnostic Imaging, Pediatric Neuroradiologist, The Hospital for Sick Children) — Principal investigator
First posted
Nov 9, 2007
Start date
May 2007
Primary completion
Mar 2008
Completion
Mar 2008
Last update
May 20, 2015

Study contacts

Manohar Shroff
principal investigator · The Hospital for Sick Children

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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