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

Primary Purpose

Intracranial Thrombosis

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Ultrasound

About this trial

This is an interventional diagnostic trial for Intracranial Thrombosis focused on measuring Intracranial Thrombosis, Cerebral Sinovenous Thrombosis, Pediatrics, Cranial Ultrasound

Eligibility Criteria

1 Hour - 28 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
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.
Where consent is available from parents.
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:

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.
If after starting the ultrasound, any signs of instability are noted during the study, the ultrasound study will discontinued.
If consent from parent or guardian is not available, the research ultrasound study will not be done.
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).
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.
Neonates & preterm infants undergoing repeat CT and/or MRs will be excluded from the study.

Sites / Locations

The Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Arm Description

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.

Outcomes

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.

Secondary Outcome Measures

The ability of doppler ultrasound to evaluate flow velocities in all dural venous sinuses that will be evaluated in this study.

Full Information

NCT ID

NCT00555932

First Posted

November 8, 2007

Last Updated

May 19, 2015

Sponsor

The Hospital for Sick Children

1. Study Identification

Unique Protocol Identification Number

NCT00555932

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hospital for Sick Children

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracranial Thrombosis

Keywords

Intracranial Thrombosis, Cerebral Sinovenous Thrombosis, Pediatrics, Cranial Ultrasound

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Ultrasound

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

Within 10 hours of the MRI scan

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Hour

Maximum Age & Unit of Time

28 Days

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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. Where consent is available from parents. 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: 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. If after starting the ultrasound, any signs of instability are noted during the study, the ultrasound study will discontinued. If consent from parent or guardian is not available, the research ultrasound study will not be done. 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). 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. Neonates & preterm infants undergoing repeat CT and/or MRs will be excluded from the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manohar Shroff

Organizational Affiliation

The Hospital for Sick Children

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Hospital for Sick Children

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X8

Country

Canada

12. IPD Sharing Statement

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed/22532234

Description

Link to final publication abstract

Learn more about this trial

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

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