NCT06045676

Brief Summary

Epilepsy is a chronic disease triggered by increased impulsiveness of nerve cells in the brain and may require a lifelong treatment. Epilepsy is confirmed by two or more unprovoked seizures in more than 24 hours. Febrile Convulsion is another type of seizure occurring due to fever over 38 °C without a history of convulsion, CNS infection, electrolyte imbalance, metabolic disorder, intoxication, and trauma. Unlike epileptic seizures, there are non-epileptic seizures such as Breath Holding Spells that affect children's behaviors and often look like epileptic seizures. QT parameters elongation show the danger of dysrhythmia and unexpected sicknesses such as cardiomyopathy, mitral valve prolapse, ischemic coronary illness, and kidney disorders. Many investigators have reported changes in QT parameters in various diseases such as diabetes mellitus, celiac disease, thalassemia , epilepsy ,Breath holding spells and febrile seizure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

September 25, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2024

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 13, 2023

Last Update Submit

September 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • QT interval

    Distance from the beginning of the Q wave to the end of the T wave at least in eight leads from the standard ECG

    12 months

Study Arms (5)

Drug Resistant Epilepsy

Seizures Not Respond to two lines of Anti epileptic Medications

Device: ECG

Drug Responsive Epilepsy

Seizures Respond to one or two lines of Anti epileptic Medications

Device: ECG

Febrile Seizures

type of seizure occurring due to fever over 38 °C without a history of convulsion

Device: ECG

Breath Holding Spells

children's behaviors look like epileptic seizures due to crying up to a minute followed by losing consciousness

Device: ECG

Control

Healthy Children free from any convulsion

Device: ECG

Interventions

ECGDEVICE

ECG with special comment on QT interval. QT interval was measured as the distance from the beginning of the Q wave to the end of the T wave at least in eight leads from the standard ECG.

Breath Holding SpellsControlDrug Resistant EpilepsyDrug Responsive EpilepsyFebrile Seizures

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

children with drug resistant epilepsy , responsive epilepsy , febrile seizures and breath holding spells with age of 1 year to 12 years

You may qualify if:

  • children with drug resistant epilepsy.
  • febrile seizures.
  • age of 1 year to 12 years.

You may not qualify if:

  • age below 1 year and above 12 years
  • children with convulsion secondary cns infection , encephalitis, encephalopathy , toxic and metabolic problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Sohag, Egypt

Location

MeSH Terms

Conditions

Seizures

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Central Study Contacts

Amany K El Zanaty, resident

CONTACT

Mohamed M Fawaz, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

September 25, 2023

Primary Completion

September 25, 2024

Study Completion

September 25, 2024

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations