Assessment of Pre Hospital Rescue Intervention for Seizure in Pediatric Patients

December 4, 2024 updated by: Samah Gamal Hussien, Assiut University
  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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Fatma abdelfatah ali
  • Phone Number: 0 1006347038

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

pediatric with seizure and take rescue intervention prehospital

Description

Inclusion Criteria:

  • Patient with recurrent attack of seizure and with prolonged seizure with prescribed treatment at home.
  • Patients aged from 2 years to 18 years

Exclusion Criteria:

  • First attack of seizure
  • condition mimic epilepsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
(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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Seizure triggers
Time Frame: Baseline

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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pre hospital TTT of seizure

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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