CompletedNot Applicable

Study on Optic Nerve Sheath Diameter Measurements in Prolonged Pediatric Seizures

Turkey (Türkiye)197 participantsStarted 2020-09-01

Plain-language summary

A total of 88 postictal children with generalized or focal seizures were included in the study. The ONSD and ONSD/ETD ratio was measured independently by a pediatric neurologist and pediatric emergency expert, three times in both eyes using non-contrasted computed tomography taken within one hour after the seizure. The characteristics of seizures (duration, etiology, initiated treatment, and frequency) were recorded. Non-traumatic patients with normal head computed tomography findings at the hospital admission were considered as the control group (n=109).

Who can participate

Age range

1 Year – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * seizures were observed by a health worker or directly with home videos. * prolonged seizures were used: those lasting more than 5 minutes for focal seizures and more than 10 minutes for generalized seizures. Exclusion Criteria: * Incomplete medical records; prior intracranial lesions, such as cysts (arachnoid, and pineal cysts), * Chiari malformations, sequelae gliotic lesions, or incidental space-occupying lesions (cavernoma, lipoma, etc.); * Chronic neuromuscular disease, metabolic or genetic disorders; * Ocular trauma, periorbital cellulitis glaucoma, refraction errors, or optic disc drusen; or a history of retinopathy of prematurity * Images with streak and movement artifacts, as well as images with pathologies that prevent measurement of the ONSD

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

elevated ICP in postictal cildren

Timeframe: 0-4 hours of emergengy department admission

to prove seizures cause elevated ICP by measuring optic nerve sheath diameter (ONSD) and optic nerve in sheath diameter to eyeball transverse diameter (ETD) ratio and comparing these results with healthy controls

Timeframe: 4th to 5th hour of emergengy department admission

to prove various seizure types cause variations in ICP and to show these can be detected by measuring optic nerve sheath diameter (ONSD) and optic nerve in sheath diameter to eyeball transverse diameter (ETD) ratio

Timeframe: 4th to 5th hour of emergengy department admission

Trial details

NCT IDNCT06451289

SponsorBalikesir University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-12-01

View on ClinicalTrials.gov More Intracranial Pressure Increase trials

Plain-language summary

Who can participate

Age range

1 Year – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

elevated ICP in postictal cildren

Timeframe: 0-4 hours of emergengy department admission

Timeframe: 4th to 5th hour of emergengy department admission