Neonatal Seizures: Semiology, Etiology, Therapy and Prognosis Correlations

NCT06308185 | Active Not Recruiting

• 1 other identifier: EPINEO
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neonatal Seizure; Epilepsy

Outcome Measures

Primary Outcomes (2)

• Seizure Type and etiology correlation

  Correlation between seizure type (ILAE classification) and etiology

  1 year

• EEG and etiology correlation

  Correlation between EEG background and EEG ictal patterns and etiology

  1 year

Secondary Outcomes (2)

• Etiology and and effective drug correlation

  1 year

• Etiology and neurobehavioral outcome correlation

  1 year

Study Arms (1)

Neonates with seizures

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

Other: observational study

Interventions

observational study OTHER

Observational retrospective study on infants with neonatal seizures

Neonates with seizures

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with epileptic seizures that occurred in the neonatal period, which were confirmed with conventional EEG or aEEG admitted to the Neonatology and Neonatal Intensive Care Unit of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

You may qualify if:

• 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;

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Related Publications (6)

• Pisani F, Facini C, Bianchi E, Giussani G, Piccolo B, Beghi E. Incidence of neonatal seizures, perinatal risk factors for epilepsy and mortality after neonatal seizures in the province of Parma, Italy. Epilepsia. 2018 Sep;59(9):1764-1773. doi: 10.1111/epi.14537. Epub 2018 Aug 22.

  PMID: 30132843 RESULT

• Cornet MC, Sands TT, Cilio MR. Neonatal epilepsies: Clinical management. Semin Fetal Neonatal Med. 2018 Jun;23(3):204-212. doi: 10.1016/j.siny.2018.01.004. Epub 2018 Jan 31.

  PMID: 29426806 RESULT

• Nunes ML, Yozawitz EG, Zuberi S, Mizrahi EM, Cilio MR, Moshe SL, Plouin P, Vanhatalo S, Pressler RM; Task Force on Neonatal Seizures, ILAE Commission on Classification & Terminology. Neonatal seizures: Is there a relationship between ictal electroclinical features and etiology? A critical appraisal based on a systematic literature review. Epilepsia Open. 2019 Jan 25;4(1):10-29. doi: 10.1002/epi4.12298. eCollection 2019 Mar.

  PMID: 30868112 RESULT

• Shellhaas RA, Wusthoff CJ, Tsuchida TN, Glass HC, Chu CJ, Massey SL, Soul JS, Wiwattanadittakun N, Abend NS, Cilio MR; Neonatal Seizure Registry. Profile of neonatal epilepsies: Characteristics of a prospective US cohort. Neurology. 2017 Aug 29;89(9):893-899. doi: 10.1212/WNL.0000000000004284. Epub 2017 Jul 21.

  PMID: 28733343 RESULT

• Fisher RS, Cross JH, French JA, Higurashi N, Hirsch E, Jansen FE, Lagae L, Moshe SL, Peltola J, Roulet Perez E, Scheffer IE, Zuberi SM. Operational classification of seizure types by the International League Against Epilepsy: Position Paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):522-530. doi: 10.1111/epi.13670. Epub 2017 Mar 8.

  PMID: 28276060 RESULT

• Pressler RM, Cilio MR, Mizrahi EM, Moshe SL, Nunes ML, Plouin P, Vanhatalo S, Yozawitz E, de Vries LS, Puthenveettil Vinayan K, Triki CC, Wilmshurst JM, Yamamoto H, Zuberi SM. The ILAE classification of seizures and the epilepsies: Modification for seizures in the neonate. Position paper by the ILAE Task Force on Neonatal Seizures. Epilepsia. 2021 Mar;62(3):615-628. doi: 10.1111/epi.16815. Epub 2021 Feb 1.

  PMID: 33522601 RESULT

MeSH Terms

Conditions

Epilepsy

Interventions

Observation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Robertino Dilena, MD

  Fondazione IRCCS C' Granda Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: June 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: July 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)