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Recruiting NCT03419260

Electrographic Seizure Management and Neurobehavioral Outcomes in Critically Ill Children

— Observational Seizures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clinically indicated EEG monitoring..
Who it may be relevant to
Registry conditions: Seizures. Basic parameters: 1 months — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

Electrographic seizures are common in critically ill patients leading to increased use of resource-intense continuous EEG monitoring for seizure identification and management. When identified, electrographic seizures are generally treated with anti-seizure medications, but there are very limited data available regarding optimal treatment in terms of the efficacy or safety of specific anti-seizure medications or overall management strategies. This is a single-center prospective observational study. The investigators aim to: (1) track critically ill patients undergoing clinically indicated EEG monitoring and seizure management to identify risk factors for electrographic seizures, (2) create prediction models guiding EEG monitoring resources to the patients at highest risk for seizures, and (3) evaluate our current management strategy in terms of safety.

Detailed description

Context: Electrographic seizures are common in critically ill patients leading to increased use of resource-intense continuous EEG monitoring for seizure identification and management. When identified, electrographic seizures are generally treated with anti-seizure medications, but there are very limited data available regarding optimal treatment in terms of specific medication selections or overall management strategies. The Children's Hospital of Philadelphia (CHOP) has a formal ICU EEG Monitoring Pathway aiming to standardize EEG monitoring and seizure management. This is a single-center prospective observational study of patients undergoing clinically indicated EEG monitoring to identify risk factors for electrographic seizures and create prediction models guiding limited EEG monitoring resources to the patients at highest risk for seizures, and also to evaluate the current seizure management strategy in terms of safety.

Objectives: The primary objective is to identify risk factors for electrographic seizures in critically ill patients and use these risk factors to create and validate a seizure prediction model. The secondary objective is to evaluate the safety of a targeted and timely electrographic seizure identification and management strategy among critically ill patients guided by a CHOP ICU EEG Monitoring Pathway.

Study Design: Single center observational study of consecutive patients undergoing clinically indicated EEG monitoring.

Setting/Participants: Single-center study of critically ill children in the Pediatric ICU at CHOP undergoing clinically indicated EEG monitoring and seizure management.

Interventions

  • Other Clinically indicated EEG monitoring.
    Children enrolled in the study will be undergoing clinically indicated EEG monitoring. Some children will undergo clinically indicated electrographic seizure management.

Primary outcome measures

  • Electrographic Seizure Occurrence [Time frame: 3 days]
Secondary outcome measures (4)
  • Safety - Mortality [Time frame: 5 days]
  • Safety - Occurrence of Cardiopulmonary adverse effects [Time frame: 5 days]
  • Safety - Occurrence of Organ Dysfunction [Time frame: 5 days]
  • Safety -Occurrence of Hospital Acquired Infections [Time frame: 5 days]

Eligibility criteria

Inclusion criteria

  • Care in the Children's Hospital of Philadelphia Pediatric ICU.
  • Clinically indicated continuous EEG monitoring.
  • Age > 1 month to 18 years.

Exclusion criteria

  • Admitted for Phase 2 (intracranial) EEG monitoring.
  • Intensivist expects to discontinue technological support in the next two days given underlying medical or neurological problems.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Children's Hospital of Philadelphia — Philadelphia

Publications

  • Fung FW, Jacobwitz M, Vala L, Parikh D, Donnelly M, Xiao R, Topjian AA, Abend NS. Electroencephalographic seizures in critically ill children: Management and adverse events. Epilepsia. 2019 Oct;60(10):2095-2104. doi: 10.1111/epi.16341. Epub 2019 Sep 20. PMID 31538340
  • Fung FW, Jacobwitz M, Parikh DS, Vala L, Donnelly M, Fan J, Xiao R, Topjian AA, Abend NS. Development of a model to predict electroencephalographic seizures in critically ill children. Epilepsia. 2020 Mar;61(3):498-508. doi: 10.1111/epi.16448. Epub 2020 Feb 20. PMID 32077099
  • Fung FW, Parikh DS, Donnelly M, Xiao R, Topjian AA, Abend NS. Electrographic Seizure Characteristics and Electrographic Status Epilepticus Prediction. J Clin Neurophysiol. 2025 Jan 1;42(1):64-72. doi: 10.1097/WNP.0000000000001068. Epub 2024 Jan 9. PMID 38194638
  • Fung FW, Parikh DS, Massey SL, Fitzgerald MP, Vala L, Donnelly M, Jacobwitz M, Kessler SK, Xiao R, Topjian AA, Abend NS. Periodic Discharges in Critically Ill Children: Predictors and Outcome. J Clin Neurophysiol. 2024 May 1;41(4):297-304. doi: 10.1097/WNP.0000000000000986. Epub 2023 Dec 1. PMID 38079254
  • Fung FW, Parikh DS, Donnelly M, Jacobwitz M, Topjian AA, Xiao R, Abend NS. EEG Monitoring in Critically Ill Children: Establishing High-Yield Subgroups. J Clin Neurophysiol. 2024 May 1;41(4):305-311. doi: 10.1097/WNP.0000000000000995. Epub 2023 Mar 8. PMID 36893385
  • Fung FW, Fan J, Parikh DS, Vala L, Donnelly M, Jacobwitz M, Topjian AA, Xiao R, Abend NS. Validation of a Model for Targeted EEG Monitoring Duration in Critically Ill Children. J Clin Neurophysiol. 2023 Nov 1;40(7):589-599. doi: 10.1097/WNP.0000000000000940. Epub 2022 Apr 20. PMID 35512186
  • Fung FW, Parikh DS, Massey SL, Fitzgerald MP, Vala L, Donnelly M, Jacobwitz M, Kessler SK, Topjian AA, Abend NS. Periodic and rhythmic patterns in critically ill children: Incidence, interrater agreement, and seizures. Epilepsia. 2021 Dec;62(12):2955-2967. doi: 10.1111/epi.17068. Epub 2021 Oct 12. PMID 34642942
  • Fung FW, Wang Z, Parikh DS, Jacobwitz M, Vala L, Donnelly M, Topjian AA, Xiao R, Abend NS. Electrographic Seizures and Outcome in Critically Ill Children. Neurology. 2021 May 31;96(22):e2749-e2760. doi: 10.1212/WNL.0000000000012032. PMID 33893203

Identifiers

NCT: NCT03419260 · 17-013808 · K02NS096058

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗