Clinical trial NCT05215366: Value of Copeptin Assay in Children With Febrile Seizures at Sohag University Hospital
Official title: Value of Copeptin Assay in Children With Febrile Seizures at Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Febrile Seizure
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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 .


Eligibility criteria: 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).

Primary outcomes:
measure: Value of copeptin assay in children with febrile seizures at Sohag University Hospital
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: 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.
citation: Leung AK, Hon KL, Leung TN. Febrile seizures: an overview. Drugs Context. 2018 Jul 16;7:212536. doi: 10.7573/dic.212536. eCollection 2018.
citation: 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.