SeizureNCT06723431
Assessment of Pre Hospital Rescue Intervention for Seizure in Pediatric Patients
An observational study of Seizure, run by Assiut University.
Trial summary
1. Evaluation of pre hospital rescue intervention of seizure management. 2. To investigate the type of rescue medication, Efficacy, route of administration, Side effects of this drug, frequency and Indication of its use. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Seizure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Nov 2025
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric with seizure and take rescue intervention prehospital
Who may be able to join
- Patient with recurrent attack of seizure and with prolonged seizure with prescribed treatment at home.
- Patients aged from 2 years to 18 years
Who cannot join
- First attack of seizure
- condition mimic epilepsy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Fatma abdelfatah ali contact
About this study
- Evaluation of pre hospital rescue intervention of seizure management.
- To investigate the type of rescue medication, Efficacy, route of administration, Side effects of this drug, frequency and Indication of its use.
Read the detailed description
An epileptic seizure is a transient occurrence with signs or symptoms due to abnormal excessive and synchronous neuronal activity in the brain.
There are many different types of seizures:
Current classification designates two large categories - partial or generalized. In a partial seizure, one area of the cortex is thought to be activated initially and may show simple symptoms such as a motor or sensory phenomena.
Partial seizures may rapidly secondarily generalize and spread to involve all cortical areas.
Generalized seizures result from diffuse cortical activation at seizure onset . Seizure cluster provides an opportunity to administer prompt treatment.
Delays in the treatment of seizure emergencies are often associated with negative patient outcomes.
Seizure clusters become less responsive to treatment when they continue unabated over time .
In addition to using anti epileptic medications, the treatment of seizures aims at correcting any identifiable causative process. Care is needed to prevent any secondary brain injury, which may include advanced respiratory and cardiovascular support. Monitoring is necessary to detect hypotension and hypoxia and steps taken to correct those conditions when recognized. Common complications may include traumatic injuries such as tongue lacerations or scalp lacerations . Convulsive status epileptic leads to brain damage on the cellular level and may itself be epileptogenic. Transformed or subtle generalized convulsive status epileptic or non convulsive seizures detected by EEG monitoring in critically ill patients may also contribute to brain laceration .
- Conditions
- Seizure
- Keywords
- seizure in pediatric patients
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| (A)Patient with seizure received rescue interventional (B) Patient with seizure didn't receive it | We will do 2 groups : Group A: Patient with recurrent attack of seizure and with prolonged seizure with prescribed treatment at home, Patients aged from 2 years to 18 years, Received rescue intervention. Group B: Patient with recurrent attack of seizure and with prolonged seizure without prescribed treatment at home, Patients aged from 2 years to 18 years, didn't Received rescue intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim of the study
- Evaluation of prehospital rescue intervention of seizure management.
- To investigate the type of rescue medication,
- it's Efficacy.
- it's route of administration.
- Side effects of this drug.
- frequency .
- Indication of it's use.
Measured: Baseline
Secondary outcomes (1)
Seizure triggers
Seizures can be triggered by things in the environment. Seizure triggers don't cause epilepsy, but they may trigger seizures in people who have epilepsy.
Most people with epilepsy don't have reliable triggers that always cause a seizure. However, they often can identify factors that make it easier to have a seizure. Possible :seizure triggers include
- Illness
- Skipping doses of antiseizure medicines or taking more than prescribed.
- Dehydration
- Lack of sleep
- Flashing lights
- Stress
- Hormone changes during the menstrual cycle• Illicit drug use
- Skipped meals
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 Dec 2024
- Study startJan 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionNov 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 SeizureStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Gamal Hussien, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723431
- Sponsor's protocol ID
- Pre hospital TTT of seizure
- Status last verified
- Dec 2024
- First submitted
- 1 Oct 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Laccheo I, Sonmezturk H, Bhatt AB, Tomycz L, Shi Y, Ringel M, DiCarlo G, Harris D, Barwise J, Abou-Khalil B, Haas KF. Non-convulsive status epilepticus and non-convulsive seizures in neurological ICU patients. Neurocrit Care. 2015 Apr;22(2):202-11. doi: 10.1007/s12028-014-0070-0.
PubMed 25246236Silbergleit R, Durkalski V, Lowenstein D, Conwit R, Pancioli A, Palesch Y, Barsan W; NETT Investigators. Intramuscular versus intravenous therapy for prehospital status epilepticus. N Engl J Med. 2012 Feb 16;366(7):591-600. doi: 10.1056/NEJMoa1107494.
PubMed 22335736Cloyd J, Haut S, Carrazana E, Rabinowicz AL. Overcoming the challenges of developing an intranasal diazepam rescue therapy for the treatment of seizure clusters. Epilepsia. 2021 Apr;62(4):846-856. doi: 10.1111/epi.16847. Epub 2021 Feb 22.
PubMed 33617690Young GB, Claassen J. Nonconvulsive status epilepticus and brain damage: further evidence, more questions. Neurology. 2010 Aug 31;75(9):760-1. doi: 10.1212/WNL.0b013e3181f32141. No abstract available.
PubMed 20805520
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pre Hospital Rescue Intervention for Seizure in Pediatric Patients
- ClinicalTrials.gov ID
- NCT06723431
- Acronym / sponsor ID
- Pre hospital TTT of seizure
- Conditions
- Seizure
- Keywords
- seizure in pediatric patients
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 9 Dec 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.
- Evaluation of pre hospital rescue intervention of seizure management.
- To investigate the type of rescue medication, Efficacy, route of administration, Side effects of this drug, frequency and Indication of its use.
Detailed description
An epileptic seizure is a transient occurrence with signs or symptoms due to abnormal excessive and synchronous neuronal activity in the brain.
There are many different types of seizures:
Current classification designates two large categories - partial or generalized. In a partial seizure, one area of the cortex is thought to be activated initially and may show simple symptoms such as a motor or sensory phenomena.
Partial seizures may rapidly secondarily generalize and spread to involve all cortical areas.
Generalized seizures result from diffuse cortical activation at seizure onset . Seizure cluster provides an opportunity to administer prompt treatment.
Delays in the treatment of seizure emergencies are often associated with negative patient outcomes.
Seizure clusters become less responsive to treatment when they continue unabated over time .
In addition to using anti epileptic medications, the treatment of seizures aims at correcting any identifiable causative process. Care is needed to prevent any secondary brain injury, which may include advanced respiratory and cardiovascular support. Monitoring is necessary to detect hypotension and hypoxia and steps taken to correct those conditions when recognized. Common complications may include traumatic injuries such as tongue lacerations or scalp lacerations . Convulsive status epileptic leads to brain damage on the cellular level and may itself be epileptogenic. Transformed or subtle generalized convulsive status epileptic or non convulsive seizures detected by EEG monitoring in critically ill patients may also contribute to brain laceration .
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| (A)Patient with seizure received rescue interventional (B) Patient with seizure didn't receive it | – | –We will do 2 groups : Group A: Patient with recurrent attack of seizure and with prolonged seizure with prescribed treatment at home, Patients aged from 2 years to 18 years, Received rescue intervention. Group B: Patient with recurrent attack of seizure and with prolonged seizure without prescribed treatment at home, Patients aged from 2 years to 18 years, didn't Received rescue intervention. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric with seizure and take rescue intervention prehospital
Key inclusion criteria (2 listed)
- Patient with recurrent attack of seizure and with prolonged seizure with prescribed treatment at home.
- Patients aged from 2 years to 18 years
Key exclusion criteria (2 listed)
- First attack of seizure
- condition mimic epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Aim of the study
Time frame: Baseline
1. Evaluation of prehospital rescue intervention of seizure management. 2. To investigate the type of rescue medication, 1. it's Efficacy. 2. it's route of administration. 3. Side effects of this drug. 4. frequency . 5. Indication of it's use.
1 secondary outcome
Seizure triggers
Time frame: Baseline
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 9 Dec 2024.
- Background: PubMed 25246236Laccheo I, Sonmezturk H, Bhatt AB, Tomycz L, Shi Y, Ringel M, DiCarlo G, Harris D, Barwise J, Abou-Khalil B, Haas KF. Non-convulsive status epilepticus and non-convulsive seizures in neurological ICU patients. Neurocrit Care. 2015 Apr;22(2):202-11. doi: 10.1007/s12028-014-0070-0.
- Background: PubMed 22335736Silbergleit R, Durkalski V, Lowenstein D, Conwit R, Pancioli A, Palesch Y, Barsan W; NETT Investigators. Intramuscular versus intravenous therapy for prehospital status epilepticus. N Engl J Med. 2012 Feb 16;366(7):591-600. doi: 10.1056/NEJMoa1107494.
- Background: PubMed 33617690Cloyd J, Haut S, Carrazana E, Rabinowicz AL. Overcoming the challenges of developing an intranasal diazepam rescue therapy for the treatment of seizure clusters. Epilepsia. 2021 Apr;62(4):846-856. doi: 10.1111/epi.16847. Epub 2021 Feb 22.
- Background: PubMed 20805520Young GB, Claassen J. Nonconvulsive status epilepticus and brain damage: further evidence, more questions. Neurology. 2010 Aug 31;75(9):760-1. doi: 10.1212/WNL.0b013e3181f32141. No abstract available.
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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.
Fatma abdelfatah ali contact
Questions about this trial
What is this clinical trial studying?
An observational study of Seizure, 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: opening soon, as of the sponsor's last update on 9 Dec 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?
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?
Contact Samah Gamal Hussien, doctor (+201025389433 ext. +201023852301, samahelewa085@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim of the study (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 NCT06723431, 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 9 Dec 2024.