Neonatal Seizures: Semiology, Etiology, Therapy and Prognosis Correlations

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

ACTIVE_NOT_RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-07-01

Brief Summary

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

Epileptic seizures in newborns (often called "neonatal convulsions") represent the most frequent neurological problem in newborns (1-3/1000 newborns). The type of seizure and their etiology is very varied and therefore the therapeutic protocol also requires adaptations with a personalization of the therapeutic approach according to the characteristics of the case according to principles of precision medicine in particular for forms of neonatal epilepsy compared to epileptic seizures acute symptomatic. In recent years it has been highlighted that the clinical characterization and instrumental characterization, in particular electroencephalographic, of epileptic seizures represents an important biomarker that allows the choice of therapy to be oriented appropriately. In the literature there is a lack of single-center studies that relate the type of crisis according to the new ILAE 2017 classification (Fisher 2017) and its proposal for neonatal adaptation (Pressler 2021) with the etiology, type of therapy and outcome neurological after a few years.

The primary aim of the study is to evaluate the correlation between the type of seizure determined according to the ILAE classification (clinical variables), the EEG findings of the epileptic seizures and the specific etiology of the epileptic seizures.

The secondary aim is to evaluate the correlation between seizure type and etiology with effective therapy, length of hospitalization and neurobehavioral development outcome. The study design is a retrospective observational on the population of neonates managed at our center in the last decade.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Novel Network Analysis of Intracranial Stereoelectroencephalography

NCT03916848

Epilepsy in Children Focal Epilepsy Epilepsy Intractable +4 more

UNKNOWN NA

Psychiatric Comorbidities in Children With Generalized Epilepsy

NCT06194422

Psychiatric Comorbidities

NOT_YET_RECRUITING

A Cohort Study on the Prognosis of Neonatal KCNQ2 Gene-associated Epileptic Encephalopathy

NCT03934268

Seizures Seizure Disorder Seizure Newborn +5 more

UNKNOWN

Observance of Anticonvulsant Treatments and Quality of Life of Epileptic Children

NCT03753035

Epilepsy Children, Only Quality of Life +2 more

UNKNOWN

Clinical Evaluation of the Efficacity of Epilepsy Surgery in Infants and Children

NCT02821260

Epilepsy

RECRUITING

Detailed Description

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

The clinical and instrumental variables that will be collected are all those relating to the diagnosis and management of neonatal epileptic seizures and the outcome of psychomotor development. The data will be those collected from the electronic medical record. The videoEEG reports will be completed by the re-evaluation of the original EEG tracing, whenever this data is available.

The official ILAE classification of 2017 by Fisher e al. (2017) and the ILAE neonatal adaptation of 2021 by Pressler et al. (2021) will be used for the seizure type classification.

The sample size is estimated at 140 subjects, approximately 10 subjects per year. The extimate derives from the calculation of the average annual incidence of newborns born in our center or transferred from other hospitals in the period 2008-2018.

Since the etiology of neonatal crises is heterogeneous and there are no preliminary scientific data currently available on the topic, it is not possible to calculate exactly a priori the number of subjects necessary for the results to be significant.

The data analysis will be primarily descriptive and epidemiological in order to detect trends in the associations between the variables. Only after this pilot phase will we try, where possible, to apply statistical tests for significance analysis.

At this point, to evaluate the associations between categorical variables (such as between the "seizure type" category and the "etiology" category), where possible, the Chi-square or Fisher test will be used and the odds ratio calculation.

To evaluate the association between quantitative variables such as the association between length of hospital stay and time of instituting the most effective drug from seizure onset (for each specific etiology), linear regression and Pearson correlation will be used. To evaluate the association between categorical variables (predictors) of the neonatal period (such as type of seizure, etiology, etc.) and developmental outcomes expressed as quantitative measures, the Spearman rank correlation test or MANOVA will be used.

Conditions

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

Neonatal Seizure Epilepsy

Study Design

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

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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

Neonates with seizures

Newborns born at term or prematurely who have had epileptic seizures documented by electroencephalogram in the neonatal period

observational study

Intervention Type OTHER

Observational retrospective study on infants with neonatal seizures

Interventions

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

observational study

Observational retrospective study on infants with neonatal seizures

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Neonatal epileptic seizures documented by conventional EEG or amplitude integrated EEG occurring within the interval from 1/1/2009 to 10/31/2022;
* Postmenstrual age at presentation of the seizure: from 23+0 and 44+6 weeks EG;

Exclusion Criteria

* Patients with a clinical diagnosis of seizures without EEG/aEEG confirmation of seizures.
* Patients who have had epileptic seizures outside the indicated postmenstrual age (from 23+0 up to 44+6)

Eligible Sex

ALL

Accepts Healthy Volunteers

No