Febrile SeizureNCT05215366
Value of Copeptin Assay in Children With Febrile Seizures at Sohag University Hospital
An observational study of Febrile Seizure, run by Sohag University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Febrile Seizure
- What is being tested?
- copeptin biomarker in children with febrile seizures
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jan 2022to 15 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study will include three groups of children (30 for each): children with febrile seizures (group 1), febrile children without seizures (group 2), and healthy control children (group 3). at Pediatric neurology outpatient clinic and Pediatric Department at Sohag University Hospital.
Who may be able to join
- Age from 6 months to 6 years.
- Seizures.
- Fever (≥38°C).
Who cannot join
- Central nervous system infection.
- Epilepsy.
- Previous neurological abnormalities.
- Inborn errors of metabolism.
- Immunological diseases.
- Endocrinal diseases (e.g., diabetes mellitus).
Show all 9Show fewer
- Obesity.
- Eating disorders.
- Gastrointestinal disorders (e.g., diarrhea).
Trial locations and contacts
1 site in 1 country.
abd el rahim A Sadek, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Osama R ElSherif, professor
About this study
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 .
- Conditions
- Febrile Seizure
- Being tested
- copeptin biomarker in children with febrile seizures
- Medical subject headings
- Seizures, Febrile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
copeptin biomarker in children with febrile seizuresDiagnostic test
biomarkers increase in children with febrile seizures
| Study group | Role | What they receive |
|---|---|---|
| children with febrile seizures | Not described Receives: Diagnostic Test: copeptin biomarker in children with febrile seizures | |
| febrile children without seizures | Not described Receives: Diagnostic Test: copeptin biomarker in children with febrile seizures | |
| healthy control children | Not described Receives: Diagnostic Test: copeptin biomarker in children with febrile seizures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of copeptin assay in children with febrile seizures at Sohag University Hospital
Serum copeptin venous blood samples (3 ml) will be obtained from children with FS (within 3 hours of seizures) as well as the two control groups. .
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start7 Jan 2022
- Primary completion1 Aug 2022 (estimated)
- Study completion15 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Febrile SeizureStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ali Abdelrady, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215366
- Sponsor's protocol ID
- Soh-Med-22-01-07
- Status last verified
- Jan 2022
- First submitted
- 18 Jan 2022
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26286537Leung AK, Hon KL, Leung TN. Febrile seizures: an overview. Drugs Context. 2018 Jul 16;7:212536. doi: 10.7573/dic.212536. eCollection 2018.
PubMed 30038660Pechmann 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.
PubMed 30605489
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Copeptin Assay in Children With Febrile Seizures at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05215366
- Acronym / sponsor ID
- Soh-Med-22-01-07
- Conditions
- Febrile Seizure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 15 Aug 2022 (estimated)
- First posted
- 31 Jan 2022 (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.
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 .
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| children with febrile seizures | – | Diagnostic Test: copeptin biomarker in children with febrile seizures |
| febrile children without seizures | – | Diagnostic Test: copeptin biomarker in children with febrile seizures |
| healthy control children | – | Diagnostic Test: copeptin biomarker in children with febrile seizures |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study will include three groups of children (30 for each): children with febrile seizures (group 1), febrile children without seizures (group 2), and healthy control children (group 3). at Pediatric neurology outpatient clinic and Pediatric Department at Sohag University Hospital.
Key inclusion criteria (3 listed)
- Age from 6 months to 6 years.
- Seizures.
- Fever (≥38°C).
Key exclusion criteria (9 listed)
- Central nervous system infection.
- Epilepsy.
- Previous neurological abnormalities.
- Inborn errors of metabolism.
- Immunological diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| copeptin biomarker in children with febrile seizuresbiomarkers increase in children with febrile seizures | Diagnostic test | children with febrile seizures, febrile children without seizures, healthy control children |
Primary outcome
Value of copeptin assay in children with febrile seizures at Sohag University Hospital
Time frame: 8 months
Serum copeptin venous blood samples (3 ml) will be obtained from children with FS (within 3 hours of seizures) as well as the two control groups. .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Background: PubMed 26286537Patel 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.
- Background: PubMed 30038660Leung AK, Hon KL, Leung TN. Febrile seizures: an overview. Drugs Context. 2018 Jul 16;7:212536. doi: 10.7573/dic.212536. eCollection 2018.
- Background: PubMed 30605489Pechmann 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
abd el rahim A Sadek, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Seizure, run by Sohag University at 1 site in Egypt.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud A abd elrady, resident (01276923636, mahmoud011175@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of copeptin assay in children with febrile seizures at Sohag University Hospital (time frame: 8 months). 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 NCT05215366, which also lists 3 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 31 Jan 2022.