Intracranial ThrombosisNCT00555932
Modern Ultrasound Techniques in the Evaluation of Cerebral Venous Sinuses in Neonates
A study testing Ultrasound in people with Intracranial Thrombosis, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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 more about this study
- Who is it for?
- Ages 1 hour to 28 days
- Conditions the study is for
- Intracranial Thrombosis
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- May 2007to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Intracranial Thrombosis
- Being tested
- Ultrasound
- Keywords
- Intracranial Thrombosis, Cerebral Sinovenous Thrombosis, Pediatrics, Cranial Ultrasound
- Medical subject headings
- Intracranial Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
All the studies will be performed with the portable ultrasound machine used on a regular basis in the neonatal care unit.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 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. Receives: Procedure: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 10 hours of MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startMay 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial ThrombosisStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manohar Shroff, The Hospital for Sick Children
- Investigators
- Manohar Shroff, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555932
- Sponsor's protocol ID
- 1000010745
- Status last verified
- May 2008
- First submitted
- 8 Nov 2007
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Modern Ultrasound Techniques in the Evaluation of Cerebral Venous Sinuses in Neonates
- ClinicalTrials.gov ID
- NCT00555932
- Acronym / sponsor ID
- 1000010745
- Conditions
- Intracranial Thrombosis
- Keywords
- Intracranial Thrombosis, Cerebral Sinovenous Thrombosis, Pediatrics, Cranial Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 9 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: UltrasoundThe 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. |
Who may qualify
- Ages
- 1 hour to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundAll the studies will be performed with the portable ultrasound machine used on a regular basis in the neonatal care unit. | Procedure or surgery | 1 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
- Link to final publication abstractLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manohar Shroff principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Intracranial Thrombosis, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.