Skip to content

Natural History and Prognosis of Pediatric Epilepsies With Different Etiology

Natural History and Prognosis of Pediatric Epilepsies With Different Etiology: Long-term Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07588971
Enrollment
2300
Registered
2026-05-15
Start date
2021-10-26
Completion date
2027-06-01
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Epilepsies

Keywords

Pediatric Epilepsies, Epilepsies, Pediatric Neuropsychiatry

Brief summary

Epilepsy is one of the most common neurological diseases in Italy, affecting about 500,000 people. Pediatric age represents one of the most affected groups with a consequent significant impact on the quality of life of the families involved. The study aims to monitor the cognitive functions of patients followed at our center in order to determine the main types of pathways and highlight their determinants. The ultimate goal is to define what are the main clinical and instrumental predictors of cognitive function and its variation over time.

Interventions

None listed

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

* Patients seen at the Children's Neuropsychiatry of the Fondazione Policlinico Gemelli IRCCS (UOS Diagnosis and Treatment of Drug-Resistant Epilepsies, Day Hospital or inpatient setting at the Department of Children's Neuropsychiatry) with onset of first seizure between the ages of 0 and 18 years and subsequent diagnostic confirmation of epilepsy (2 or more unprovoked seizures at least 24 hours apart or definite epilepsy syndrome, with diagnostic confirmation by the child neuropsychiatrist). * Patients already followed at Child Neuropsychiatry with a diagnosis of epilepsy with age of onset between 0 and 18 years. * Patients referred to our Center during follow-up with a diagnosis of epilepsy with age of onset between 0 and 18 years.

Exclusion criteria

* Patients with unconfirmed diagnosis of epilepsy after the first critical episode. * Patients from other Centers, for whom the history, clinical and instrumental data are not sufficiently detailed and in accordance with the methodologies followed at our Center. * Patients with follow-up \< 2 years. * Patients for whom study consent is not provided.

Design outcomes

Primary

MeasureTime frameDescription
neurodevelopment level12 months after entry visitEvaluate prescholar global development and scholar cognitive level with Griffiths or Weschler scales where applicable according to age.

Secondary

MeasureTime frameDescription
Seizure outcome24 months after entry visitEvaluate the reduction in seizures (percentage)
QOLIE-3124 months after entry visitEvaluate the Impact of the Epilepsy on the quality of life
Clinical Global Impression Scale24 months after entry visitEvaluate the global clinical impression to have a measure of epilepsy severity and the burden of antiseizure medication on daily life.

Countries

Italy

Contacts

CONTACTDomenica Immacolata Battaglia, MD
domenicaimmacolata.battaglia@policlinicogemelli.it+39 0630159222
CONTACTMichela Quintiliani, MD
michela.quintiliani@guest.policlinicogemelli.it+39 0630159222
PRINCIPAL_INVESTIGATORDomenica Immacolata Battaglia

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026