MedDataX Logo

Value of Copeptin Assay in Children With Febrile Seizures at Sohag University Hospital

NCT ID: NCT05215366

Last Updated: 2022-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-07

Study Completion Date

2022-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Febrile seizures are one of the most common clinical diseases in pediatric neurology. It occurs between 6 months and 6 years of age and occurs in \~2-5% of children. According to the age, frequency, duration, and type of seizures FS is divided into simple febrile seizures and complex febrile seizures Differentiation between febrile seizures and non-ictal events associated with fever such as shivering or dizziness is challenging. Therefore, precise diagnosis of FS after paroxysmal episodes associated with fever is often hindered by the lack of an objective biomarker With the widespread application of technologies, such as molecular biology, in medicine, some biomarkers for predicting or diagnosing FS have attracted attention. Imuekemhe et al in 1989 and 1996 found that lactic acid in the serum and cerebrospinal fluid of children with FS was significantly increased . Arginin-vasopressin hormone AVP released by the pituitary gland, has been shown to be involved in the thermoregulatory response to fever and convulsions Although AVP is unstable in the peripheral blood and, therefore, unsuited for diagnostic use the C-terminal portion of the AVP precursor copeptin has been recognized as a robust marker of AVP secretion . Wellman et al. found that the serum copeptin and Von Willebrand factor of children with FS were significantly higher than those of the control group .

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Febrile Seizure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

children with febrile seizures

copeptin biomarker in children with febrile seizures

Intervention Type DIAGNOSTIC_TEST

biomarkers increase in children with febrile seizures

febrile children without seizures

copeptin biomarker in children with febrile seizures

Intervention Type DIAGNOSTIC_TEST

biomarkers increase in children with febrile seizures

healthy control children

copeptin biomarker in children with febrile seizures

Intervention Type DIAGNOSTIC_TEST

biomarkers increase in children with febrile seizures

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

copeptin biomarker in children with febrile seizures

biomarkers increase in children with febrile seizures

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age from 6 months to 6 years.
* Seizures.
* Fever (≥38°C).

Exclusion Criteria

* Central nervous system infection.
* Epilepsy.
* Previous neurological abnormalities.
* Inborn errors of metabolism.
* Immunological diseases.
* Endocrinal diseases (e.g., diabetes mellitus).
* Obesity.
* Eating disorders.
* Gastrointestinal disorders (e.g., diarrhea).
Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sohag University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mahmoud Ali Abdelrady

resident doctor at pediateric department sohag university hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sohag University Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mahmoud A abd elrady, resident

Role: CONTACT

Phone: 01276923636

Email: [email protected]

abd el rahim A Sadek, professor

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Osama R ElSherif, professor

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Patel N, Ram D, Swiderska N, Mewasingh LD, Newton RW, Offringa M. Febrile seizures. BMJ. 2015 Aug 18;351:h4240. doi: 10.1136/bmj.h4240. No abstract available.

Reference Type BACKGROUND
PMID: 26286537 (View on PubMed)

Leung AK, Hon KL, Leung TN. Febrile seizures: an overview. Drugs Context. 2018 Jul 16;7:212536. doi: 10.7573/dic.212536. eCollection 2018.

Reference Type BACKGROUND
PMID: 30038660 (View on PubMed)

Pechmann A, Wellmann S, Stoecklin B, Kruger M, Zieger B. Increased von Willebrand factor parameters in children with febrile seizures. PLoS One. 2019 Jan 3;14(1):e0210004. doi: 10.1371/journal.pone.0210004. eCollection 2019.

Reference Type BACKGROUND
PMID: 30605489 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Soh-Med-22-01-07

Identifier Type: -

Identifier Source: org_study_id