Intracranial AbscessNCT07051382
Transcranial Sonographic Evaluation of Preterm Neonates Presenting With Seizures and Its Association With IA
An observational study of Intracranial Abscess, run by Superior University at 1 site in Pakistan.
Trial summary
This study aimed to evaluate preterm neonates presenting with seizures using transcranial sonography (cranial ultrasound) to detect intracranial abnormalities. Read more about this study
- Who is it for?
- Ages 1 week to 20 weeks
- Conditions the study is for
- Intracranial Abscess
- What is being tested?
- Transcranial Sonographic Examination (Cranial Ultrasound)
- How many people
- 122 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Mar 2025to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 week to 20 weeks
- All sexes
- No healthy volunteers
- Child
Study population: This group consisted of preterm neonates who presented with seizures and showed abnormalities on cranial ultrasound, such as: Germinal Matrix ,Hemorrhage (GMH) Intraventricular, Periventricular Leukomalacia (PVL) , Hydrocephalus , Cerebral infarction or parenchymal lesions.
Who may be able to join
- Both genders during neonatal period i.e. up to 28 days of postnatal life.
- Seizures having any birth weight and gestational age.3.6.2
Who cannot join
- Preterm with Congenital spinal anomalies causing seizures such as spina-bifida, scoliosisetc.
- Extra-cranial anomalies causing seizures such as arteriovenous malformation (AVM) or metabolic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Sonographic Evaluation of Preterm Neonates Presenting With Seizures and Its Association With Intracranial Abnormalities
This study aimed to evaluate preterm neonates presenting with seizures using transcranial sonography (cranial ultrasound) to detect intracranial abnormalities.
Read the detailed description
To determine the prevalence and types of intracranial abnormalities detected by transcranial sonography in preterm neonates who present with seizures, and to analyze the association between these findings and clinical outcomes.
- Conditions
- Intracranial Abscess
- Being tested
- Transcranial Sonographic Examination (Cranial Ultrasound)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Sonographic Examination (Cranial Ultrasound)Diagnostic test
No evidence of intracranial abnormalities such as intraventricular hemorrhage, germinal matrix hemorrhage, periventricular leukomalacia, hydrocephalus, or infarction.
Brain structures were assessed to be age-appropriate for gestational development.
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Administred Questioner
Self Administred Questioner for taking the data and values
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start17 Mar 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AbscessStudies of the same condition, open and under way.
- More trials run by Superior 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-control
- Time perspective
- Retrospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051382
- Sponsor's protocol ID
- MSAHSW/Batch-Fall23/921
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Sonographic Evaluation of Preterm Neonates Presenting With Seizures and Its Association With Intracranial Abnormalities
- ClinicalTrials.gov ID
- NCT07051382
- Acronym / sponsor ID
- MSAHSW/Batch-Fall23/921
- Conditions
- Intracranial Abscess
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 4 Jul 2025 (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.
This study aimed to evaluate preterm neonates presenting with seizures using transcranial sonography (cranial ultrasound) to detect intracranial abnormalities.
Detailed description
To determine the prevalence and types of intracranial abnormalities detected by transcranial sonography in preterm neonates who present with seizures, and to analyze the association between these findings and clinical outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 week to 20 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This group consisted of preterm neonates who presented with seizures and showed abnormalities on cranial ultrasound, such as: Germinal Matrix ,Hemorrhage (GMH) Intraventricular, Periventricular Leukomalacia (PVL) , Hydrocephalus , Cerebral infarction or parenchymal lesions.
Key inclusion criteria (2 listed)
- Both genders during neonatal period i.e. up to 28 days of postnatal life.
- Seizures having any birth weight and gestational age.3.6.2
Key exclusion criteria (2 listed)
- Preterm with Congenital spinal anomalies causing seizures such as spina-bifida, scoliosisetc.
- Extra-cranial anomalies causing seizures such as arteriovenous malformation (AVM) or metabolic diseases.
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 Sonographic Examination (Cranial Ultrasound)No evidence of intracranial abnormalities such as intraventricular hemorrhage, germinal matrix hemorrhage, periventricular leukomalacia, hydrocephalus, or infarction. Brain structures were assessed to be age-appropriate for gestational development. | Diagnostic test | – |
Primary outcome
Self Administred Questioner
Time frame: 12 Months
Self Administred Questioner for taking the data and values
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Abscess, run by Superior University at 1 site in Pakistan.
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: under way, not looking for participants, as of the sponsor's last update on 4 Jul 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Self Administred Questioner (time frame: 12 Months). 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 4 Jul 2025.