NCT06723431

Brief Summary

  1. 1.Evaluation of pre hospital rescue intervention of seizure management.
  2. 2.To investigate the type of rescue medication, Efficacy, route of administration, Side effects of this drug, frequency and Indication of its use.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

9 months

First QC Date

October 1, 2024

Last Update Submit

December 4, 2024

Conditions

Keywords

seizure in pediatric patients

Outcome Measures

Primary Outcomes (1)

  • Aim of the study

    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 Outcomes (1)

  • Seizure triggers

    Baseline

Study Arms (1)

(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.

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pediatric with seizure and take rescue intervention prehospital

You may qualify if:

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

You may not qualify if:

  • First attack of seizure
  • condition mimic epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 25246236BACKGROUND
  • Silbergleit 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.

    PMID: 22335736BACKGROUND
  • Cloyd 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.

    PMID: 33617690BACKGROUND
  • Young 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.

    PMID: 20805520BACKGROUND

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Samah Gamal Hussien, doctor

CONTACT

Fatma abdelfatah ali

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assessment of pre hospital rescue intervention for seizure in pediatric patients

Study Record Dates

First Submitted

October 1, 2024

First Posted

December 9, 2024

Study Start

January 1, 2025

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

December 9, 2024

Record last verified: 2024-12