Trancranial DopplerNCT06352931
Transcranial Ultrasound and Transcranial Doppler in Diagnosis and Detection of Outcome in Infants With Neurological Diseases
An observational study of Trancranial Doppler, run by Assiut University.
Trial summary
To evaluate the accuracy of transcranial ultrasound in detection of brain pathology in infants with neurological diseases and value of transcranial Doppler in evaluation of intracerebral blood flow in comparison with other radiological modalities according to available imaging. Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Trancranial Doppler
- What is being tested?
- transcranial and transcranial dopp;er
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 30 Jul 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 day to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Newborns and infants (from birth to 2years) with open anterior fontanelle presented with any neurological signs e.g: convulsions, disturbed conscious level \&coma, suspected CNS infection macrocephaly, head trauma, multiple congenital anomalies, persistent vomiting, bulging anterior fontanelle, developmental delay, neurological deficit
Who may be able to join
- Newborns and infants (from birth to 2years) with open anterior fontanelle presented with any neurological signs e.g: convulsions, disturbed conscious level \&coma, suspected CNS infection macrocephaly, head trauma, multiple congenital anomalies, persistent vomiting, bulging anterior fontanelle, developmental delay, neurological deficit.
- -
Who cannot join
- 1-Children with closed anterior fontanelle. 2- Infants without neurological signs.
- -
Trial locations and contacts
No sites are listed yet.
About this study
To evaluate the accuracy of transcranial ultrasound in detection of brain pathology in infants with neurological diseases and value of transcranial Doppler in evaluation of intracerebral blood flow in comparison with other radiological modalities according to available imaging.
Read the detailed description
Neurologic disorders are seen commonly in children, especially in developing countries [1]. They significantly contribute to morbidity and disability in children and contribute significantly to chronic illness and its burden on children [2]. They can result from genetic or environmental factors or a combination of both [3]. Many relatively rare conditions which have high mortality in the past, like cancers, spinal bifida, and sickle cell anemia, now survive and contribute to the burden of chronic childhood diseases [4]. That's why early detection and management of neurological manifestations is very important.
Head and neck radiology has evolved during the century since the discovery of the x ray in 1895 by Wilhelm Conrad Roentgen. In the first few decades, conventional radiography was the diagnostic modality for evaluation of head and neck diseases, Linear tomography was further enhanced with the introduction of thin-section polytomography especially of the temporal bone in 1954, Computed tomography in 1972 and magnetic resonance imaging in 1982 improved our diagnostic capabilities by enabling location and characterization of tumors, cysts, and inflammatory processes in the head and neck and aiding in earlier diagnosis and treatment (5) Dewbury et al in 1980 first reported the use of anterior fontanelle as a bone free window through which brain can be imaged. Since then this technique has become widely accepted and is regarded as the primary imaging method for the neonatal brain [6] A cranial ultrasound is also known as a 'head scan'. Sound waves are used to look at the brain structure and the fluid spaces within the brain (ventricles). It does not involve any ionizing radiation [7] .
Ultrasound waves travel into tissue and are reflected back to the probe at a rate determined by the target tissue's consistency. Reflections of sound that return to the probe are called echoes and are determined by two different materials' interfaces.[8] Cranial US has become an essential primary diagnostic screening tool for intracranial pathologic conditions in infants. Significant technical advances including use of high frequency transducers, imaging through secondary acoustic windows, and incorporation of Doppler imaging allow a comprehensive evaluation of the brain. In addition, US is noninvasive, requires no sedation, can be performed at the bedside with minimal disturbance to the neonate and infants, and may be repeated as often as necessary. [9] Various studies have demonstrated high sensitivity and specificity of transcranial ultrasound in detection of various intracranial abnormalities [10].
Most cranial sonographic examinations are performed in coronal and the sagittal planes, through the anterior fontanelle that remains useful for scanning 12-14 months of age infants . Posterior and mastoid fontanelles provide a better window for evaluation of posterior fossa structures Pterion is an important window for evaluation of circle of willis .[11] In spite of these views are indispensable for evaluation of posterior fossa malformations as they provide highly detailed views of the cerebellum, fourth ventricle, cisterna magna, and upper spinal canal. Coronal and sagittal planes are the most useful imaging planes for cranial sonography and allow a comprehensive brain examination, they afford a useful window for a limited age only i.e. up to 6 months. [12] Transcranial ultrasound helps in imaging of brain and intraventricular chambers through sound waves reflected from the brain and cerebrospinal fluid (CSF). For the evaluation of extra-axial fluid space, meninges, sinuses, convolutional markings and cerebral cortex, high frequency linear array transducers are better to be used .[13] Many pathological lesions could be detected by trans-cranial ultrasound as Neonatal hypoxic lesions and intracranial hemorrhagic lesions with the resulting ventricular dilatation. Also, it is the technique of choice in detection of periventricular leukomalecia (PVL) . It can detect many congenital malformations of the brain as hydrocephalus secondary to aqueductal stenosis, Chiari II malformation, posterior fossa cystic abnormalities including Dandy-Walker spectrum, holoprosencephaly , schizencephaly, agenesis of the corpus callosum (CC), vein of Galen malformation and arachnoid cysts. Cranial ultrasound also shows high sensitivity in detection of calcification foci resulting from congenital TORCH infection. Finally Intracranial neoplasms which are rare in neonates and infants can be seen by cranial sonography [14].
Transcranial Doppler (TCD) ultrasound including color flow(CF) and pulsed wave (PW) enables the bedside evaluation of these patients; it is a non-invasive, readily available technique for the real-time assessment and monitoring of cerebral blood flow. TCD shows high sensitivity and specificity for the diagnosis of vasospasm after subarachnoid hemorrhage, acute middle cerebral artery (MCA) occlusions and brain death [15]. Furthermore, TCD is a reliable method for estimating the intracranial pressure (ICP) - particularly in the context of traumatic brain injury [16]. The use of TCD has also been described in the management of sepsis [17], central nervous system (CNS) infections [18], and liver and kidney failure [19,20] , there is good evidence to support the use of TCD in screening for sickle cell disease in children and whose risk of a first stroke would be reduced by a blood transfusion [21] Three key parameters can be obtained from the Doppler spectrum: flow direction, velocities, and indices for arterial resistance. Flow direction can be assessed by the colour code. By convention, flow towards the transducer is coded in red and is plotted above the baseline in the pulsed wave Doppler-spectrum; flow away from the transducer is coded in blue and plotted below the baseline. The most commonly used velocity parameter is the time average mean of the maximal velocities (TAMX), also called mean velocity, obtained by manual or automated outlining of the envelope of the spectral waveform over one cardiac cycle. The peak systolic velocity (PSV) and end diastolic velocity (EDV) can also be measured. Two indices reflecting the downstream vascular resistance can be calculated. The pulsatility index (PI) is calculated as PI = (PSV -EDV) / TAMX. The resistance index, RI, is equal to (PSV - EDV) / PSV. [22].
- Conditions
- Trancranial Doppler
- Being tested
- transcranial and transcranial dopp;er
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial and transcranial dopp;erDevice
All patients will be subjected to Transcranial ultrasound examination and compared with other neuroimaging modalities: CT brain or MRI brain and/or MRA \& MRV.
Patients suspected to have ischemic or hemorrhagic disorder, CNS infection or increase intracranial pressure will be evaluated with transcranial Doppler ultrasound and compared with other neuroimaging modalities.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the accuracy of transcranial ultrasound in detection of brain pathology in infants with neurological diseases and value of transcranial doppler
To evaluate the accuracy of transcranial ultrasound in detection of brain pathology in infants with neurological diseases and value of transcranial Doppler in evaluation of intracerebral blood flow in comparison with other radiological modalities according to available imaging.
Measured: one year duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Trancranial DopplerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Sami Abdelrahman Khalifa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352931
- Sponsor's protocol ID
- TCD & TCUS in infants
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kawakatsu Y, Kaneko S, Karama M, Honda S. Prevalence and risk factors of neurological impairment among children aged 6-9 years: from population based cross sectional study in western Kenya. BMC Pediatr. 2012 Dec 3;12:186. doi: 10.1186/1471-2431-12-186.
PubMed 23206271Weber AL. History of head and neck radiology: past, present, and future. Radiology. 2001 Jan;218(1):15-24. doi: 10.1148/radiology.218.1.r01ja2715.
PubMed 11152774Richer EJ, Riedesel EL, Linam LE. Review of Neonatal and Infant Cranial US. Radiographics. 2021 Nov-Dec;41(7):E206-E207. doi: 10.1148/rg.2021210089. No abstract available.
PubMed 34723697Gupta P, Sodhi KS, Saxena AK, Khandelwal N, Singhi P. Neonatal cranial sonography: A concise review for clinicians. J Pediatr Neurosci. 2016 Jan-Mar;11(1):7-13. doi: 10.4103/1817-1745.181261.
PubMed 27195026
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Ultrasound and Transcranial Doppler in Diagnosis and Detection of Outcome in Infants With Neurological Diseases
- ClinicalTrials.gov ID
- NCT06352931
- Acronym / sponsor ID
- TCD & TCUS in infants
- Conditions
- Trancranial Doppler
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 8 Apr 2024 (actual)
- 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.
To evaluate the accuracy of transcranial ultrasound in detection of brain pathology in infants with neurological diseases and value of transcranial Doppler in evaluation of intracerebral blood flow in comparison with other radiological modalities according to available imaging.
Detailed description
Neurologic disorders are seen commonly in children, especially in developing countries [1]. They significantly contribute to morbidity and disability in children and contribute significantly to chronic illness and its burden on children [2]. They can result from genetic or environmental factors or a combination of both [3]. Many relatively rare conditions which have high mortality in the past, like cancers, spinal bifida, and sickle cell anemia, now survive and contribute to the burden of chronic childhood diseases [4]. That's why early detection and management of neurological manifestations is very important.
Head and neck radiology has evolved during the century since the discovery of the x ray in 1895 by Wilhelm Conrad Roentgen. In the first few decades, conventional radiography was the diagnostic modality for evaluation of head and neck diseases, Linear tomography was further enhanced with the introduction of thin-section polytomography especially of the temporal bone in 1954, Computed tomography in 1972 and magnetic resonance imaging in 1982 improved our diagnostic capabilities by enabling location and characterization of tumors, cysts, and inflammatory processes in the head and neck and aiding in earlier diagnosis and treatment (5) Dewbury et al in 1980 first reported the use of anterior fontanelle as a bone free window through which brain can be imaged. Since then this technique has become widely accepted and is regarded as the primary imaging method for the neonatal brain [6] A cranial ultrasound is also known as a 'head scan'. Sound waves are used to look at the brain structure and the fluid spaces within the brain (ventricles). It does not involve any ionizing radiation [7] .
Ultrasound waves travel into tissue and are reflected back to the probe at a rate determined by the target tissue's consistency. Reflections of sound that return to the probe are called echoes and are determined by two different materials' interfaces.[8] Cranial US has become an essential primary diagnostic screening tool for intracranial pathologic conditions in infants. Significant technical advances including use of high frequency transducers, imaging through secondary acoustic windows, and incorporation of Doppler imaging allow a comprehensive evaluation of the brain. In addition, US is noninvasive, requires no sedation, can be performed at the bedside with minimal disturbance to the neonate and infants, and may be repeated as often as necessary. [9] Various studies have demonstrated high sensitivity and specificity of transcranial ultrasound in detection of various intracranial abnormalities [10].
Most cranial sonographic examinations are performed in coronal and the sagittal planes, through the anterior fontanelle that remains useful for scanning 12-14 months of age infants . Posterior and mastoid fontanelles provide a better window for evaluation of posterior fossa structures Pterion is an important window for evaluation of circle of willis .[11] In spite of these views are indispensable for evaluation of posterior fossa malformations as they provide highly detailed views of the cerebellum, fourth ventricle, cisterna magna, and upper spinal canal. Coronal and sagittal planes are the most useful imaging planes for cranial sonography and allow a comprehensive brain examination, they afford a useful window for a limited age only i.e. up to 6 months. [12] Transcranial ultrasound helps in imaging of brain and intraventricular chambers through sound waves reflected from the brain and cerebrospinal fluid (CSF). For the evaluation of extra-axial fluid space, meninges, sinuses, convolutional markings and cerebral cortex, high frequency linear array transducers are better to be used .[13] Many pathological lesions could be detected by trans-cranial ultrasound as Neonatal hypoxic lesions and intracranial hemorrhagic lesions with the resulting ventricular dilatation. Also, it is the technique of choice in detection of periventricular leukomalecia (PVL) . It can detect many congenital malformations of the brain as hydrocephalus secondary to aqueductal stenosis, Chiari II malformation, posterior fossa cystic abnormalities including Dandy-Walker spectrum, holoprosencephaly , schizencephaly, agenesis of the corpus callosum (CC), vein of Galen malformation and arachnoid cysts. Cranial ultrasound also shows high sensitivity in detection of calcification foci resulting from congenital TORCH infection. Finally Intracranial neoplasms which are rare in neonates and infants can be seen by cranial sonography [14].
Transcranial Doppler (TCD) ultrasound including color flow(CF) and pulsed wave (PW) enables the bedside evaluation of these patients; it is a non-invasive, readily available technique for the real-time assessment and monitoring of cerebral blood flow. TCD shows high sensitivity and specificity for the diagnosis of vasospasm after subarachnoid hemorrhage, acute middle cerebral artery (MCA) occlusions and brain death [15]. Furthermore, TCD is a reliable method for estimating the intracranial pressure (ICP) - particularly in the context of traumatic brain injury [16]. The use of TCD has also been described in the management of sepsis [17], central nervous system (CNS) infections [18], and liver and kidney failure [19,20] , there is good evidence to support the use of TCD in screening for sickle cell disease in children and whose risk of a first stroke would be reduced by a blood transfusion [21] Three key parameters can be obtained from the Doppler spectrum: flow direction, velocities, and indices for arterial resistance. Flow direction can be assessed by the colour code. By convention, flow towards the transducer is coded in red and is plotted above the baseline in the pulsed wave Doppler-spectrum; flow away from the transducer is coded in blue and plotted below the baseline. The most commonly used velocity parameter is the time average mean of the maximal velocities (TAMX), also called mean velocity, obtained by manual or automated outlining of the envelope of the spectral waveform over one cardiac cycle. The peak systolic velocity (PSV) and end diastolic velocity (EDV) can also be measured. Two indices reflecting the downstream vascular resistance can be calculated. The pulsatility index (PI) is calculated as PI = (PSV -EDV) / TAMX. The resistance index, RI, is equal to (PSV - EDV) / PSV. [22].
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborns and infants (from birth to 2years) with open anterior fontanelle presented with any neurological signs e.g: convulsions, disturbed conscious level \&coma, suspected CNS infection macrocephaly, head trauma, multiple congenital anomalies, persistent vomiting, bulging anterior fontanelle, developmental delay, neurological deficit
Key inclusion criteria (2 listed)
- Newborns and infants (from birth to 2years) with open anterior fontanelle presented with any neurological signs e.g: convulsions, disturbed conscious level \&coma, suspected CNS infection macrocephaly, head trauma, multiple congenital anomalies, persistent vomiting, bulging anterior fontanelle, developmental delay, neurological deficit.
- -
Key exclusion criteria (2 listed)
- 1-Children with closed anterior fontanelle. 2- Infants without neurological signs.
- -
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 |
|---|---|---|
| transcranial and transcranial dopp;erAll patients will be subjected to Transcranial ultrasound examination and compared with other neuroimaging modalities: CT brain or MRI brain and/or MRA \& MRV. Patients suspected to have ischemic or hemorrhagic disorder, CNS infection or increase intracranial pressure will be evaluated with transcranial Doppler ultrasound and compared with other neuroimaging modalities. | Device | – |
Primary outcome
To evaluate the accuracy of transcranial ultrasound in detection of brain pathology in infants with neurological diseases and value of transcranial doppler
Time frame: one year duration
To evaluate the accuracy of transcranial ultrasound in detection of brain pathology in infants with neurological diseases and value of transcranial Doppler in evaluation of intracerebral blood flow in comparison with other radiological modalities according to available imaging.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Background: PubMed 23206271Kawakatsu Y, Kaneko S, Karama M, Honda S. Prevalence and risk factors of neurological impairment among children aged 6-9 years: from population based cross sectional study in western Kenya. BMC Pediatr. 2012 Dec 3;12:186. doi: 10.1186/1471-2431-12-186.
- Background: PubMed 11152774Weber AL. History of head and neck radiology: past, present, and future. Radiology. 2001 Jan;218(1):15-24. doi: 10.1148/radiology.218.1.r01ja2715.
- Background: PubMed 34723697Richer EJ, Riedesel EL, Linam LE. Review of Neonatal and Infant Cranial US. Radiographics. 2021 Nov-Dec;41(7):E206-E207. doi: 10.1148/rg.2021210089. No abstract available.
- Background: PubMed 27195026Gupta P, Sodhi KS, Saxena AK, Khandelwal N, Singhi P. Neonatal cranial sonography: A concise review for clinicians. J Pediatr Neurosci. 2016 Jan-Mar;11(1):7-13. doi: 10.4103/1817-1745.181261.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Trancranial Doppler, run by Assiut University.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa Khalifa, master (00201006379716, esraasami225@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the accuracy of transcranial ultrasound in detection of brain pathology in infants with neurological diseases and value of transcranial doppler (time frame: one year duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06352931, which also lists 4 linked publications.
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 8 Apr 2024.