Brain AbnormalitiesNCT05113108
Transcranial Ultrasound Screening of Nursery Unit Neonatesfor Brain Abnormalities
An observational study of Brain Abnormalities, run by Basma Fawzy Abd Elhameed Ali.
Trial summary
To investigate the prevalence of cerebral abnormal findings in neonates admitted at nursery unit.{11} to identify the associated clinical features and to better target neonatal CUS investigations.{11} Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Brain Abnormalities
- What is being tested?
- CUS
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to Feb 2023
- 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 28 days
- All sexes
- Child
Study population: Neonates undergoing CUS at nursery unit at university hospital
Who may be able to join
- All neonates suspected clinically to be suffered from brain lesions at nursery unit at assiut university hospitals
Who cannot join
- Patients above the age of 28 days
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Transcranial Ultrasound Screening of Nursery Unit Neonatesfor Brain Abnormalities in Assuit University Hospital
- To investigate the prevalence of cerebral abnormal findings in neonates admitted at nursery unit.{11}
- to identify the associated clinical features and to better target neonatal CUS investigations.{11}
Read the detailed description
Preterm birth is associated with various brain injuries. The earlier the period of gestation, more is the incidence of brain injuries. Brain injuries are known to be one of the most important factors leading to significant morbidity and mortality in these vulnerable preterm babies.{1} Cranial ultrasound (CUS) examinations have been performed on preterm infants to diagnose various perinatal brain injuries and for the prediction of long term outcomes.{2} Cranial ultrasonography (CUS) is the preferred modality to image the neonatal brain.{3} The advantages of CUS are numerous: it can be performed at the bedside with little disturbance to the infant, it is relatively safe, and can be repeated whenever needed, enabling visualization of ongoing brain maturation and the evolution of lesions.{4,5}
- Conditions
- Brain Abnormalities
- Being tested
- CUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUSDevice
All neonates undergoing CUS at nursery unit at assiut university hospital. Cranial ultrasound is performed with basic grayscale imaging. For optimal resolution and good overview, a multifrequency (5-10 MHz) linear or convex sector transducer is used. Imaging is obtained through the anterior fontanel in the coronal and sagittal planes.{12,13} Typically, six to eight coronal images are obtained beginning at the frontal lobes just anterior to the frontal horns and extending to the occipital lobes posterior to the lateral ventricle trigones.{14} The transducer is then rotated 90°, and approximately five images are obtained, including a midline sagittal view of the corpus callosum and cerebellar vermis in addition to bilateral parasagittal images beginning in the midline and progressing laterally through the peripheral cortex.Doppler ultrasound may be added to assess ischemic areas.{13-15}
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the preavalence of cerebral abnormal findings in neonates
Cranial Ultrasound is performed with basic grayscale imaging
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain AbnormalitiesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basma Fawzy Abd Elhameed Ali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Basma Fawzy Abd Elhameed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113108
- Sponsor's protocol ID
- Neonatal cranial Ultrasound
- Status last verified
- Nov 2021
- First submitted
- 28 Oct 2021
- Last updated
- 29 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maalouf EF, Duggan PJ, Counsell SJ, Rutherford MA, Cowan F, Azzopardi D, Edwards AD. Comparison of findings on cranial ultrasound and magnetic resonance imaging in preterm infants. Pediatrics. 2001 Apr;107(4):719-27. doi: 10.1542/peds.107.4.719.
PubMed 11335750
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Ultrasound Screening of Nursery Unit Neonatesfor Brain Abnormalities in Assuit University Hospital
- ClinicalTrials.gov ID
- NCT05113108
- Acronym / sponsor ID
- Neonatal cranial Ultrasound
- Conditions
- Brain Abnormalities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Basma Fawzy Abd Elhameed AliUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 9 Nov 2021 (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 investigate the prevalence of cerebral abnormal findings in neonates admitted at nursery unit.{11}
- to identify the associated clinical features and to better target neonatal CUS investigations.{11}
Detailed description
Preterm birth is associated with various brain injuries. The earlier the period of gestation, more is the incidence of brain injuries. Brain injuries are known to be one of the most important factors leading to significant morbidity and mortality in these vulnerable preterm babies.{1} Cranial ultrasound (CUS) examinations have been performed on preterm infants to diagnose various perinatal brain injuries and for the prediction of long term outcomes.{2} Cranial ultrasonography (CUS) is the preferred modality to image the neonatal brain.{3} The advantages of CUS are numerous: it can be performed at the bedside with little disturbance to the infant, it is relatively safe, and can be repeated whenever needed, enabling visualization of ongoing brain maturation and the evolution of lesions.{4,5}
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- Neonates undergoing CUS at nursery unit at university hospital
Key inclusion criteria (1 listed)
- All neonates suspected clinically to be suffered from brain lesions at nursery unit at assiut university hospitals
Key exclusion criteria (1 listed)
- Patients above the age of 28 days
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 |
|---|---|---|
| CUSAll neonates undergoing CUS at nursery unit at assiut university hospital. Cranial ultrasound is performed with basic grayscale imaging. For optimal resolution and good overview, a multifrequency (5-10 MHz) linear or convex sector transducer is used. Imaging is obtained through the anterior fontanel in the coronal and sagittal planes.{12,13} Typically, six to eight coronal images are obtained beginning at the frontal lobes just anterior to the frontal horns and extending to the occipital lobes posterior to the lateral ventricle trigones.{14} The transducer is then rotated 90°, and approximately five images are obtained, including a midline sagittal view of the corpus callosum and cerebellar vermis in addition to bilateral parasagittal images beginning in the midline and progressing laterally through the peripheral cortex.Doppler ultrasound may be added to assess ischemic areas.{13-15} | Device | – |
Primary outcome
Investigate the preavalence of cerebral abnormal findings in neonates
Time frame: Baseline
Cranial Ultrasound is performed with basic grayscale imaging
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Background: PubMed 11335750Maalouf EF, Duggan PJ, Counsell SJ, Rutherford MA, Cowan F, Azzopardi D, Edwards AD. Comparison of findings on cranial ultrasound and magnetic resonance imaging in preterm infants. Pediatrics. 2001 Apr;107(4):719-27. doi: 10.1542/peds.107.4.719.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Abnormalities, run by Basma Fawzy Abd Elhameed Ali.
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 1 inclusion and 1 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 29 Nov 2021. 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 Basma Fawzy, Resident doc (01062646952, basmafawzy80@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate the preavalence of cerebral abnormal findings in neonates (time frame: Baseline). 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 NCT05113108, which also lists 1 linked publication.
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 29 Nov 2021.