NCT03419260

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Mar 2017Jan 2027

Study Start

First participant enrolled

March 13, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 4, 2025

Status Verified

February 1, 2025

Enrollment Period

9.8 years

First QC Date

January 24, 2018

Last Update Submit

February 3, 2025

Conditions

Seizures

Keywords

seizuresstatus epilepticusEEG monitoring

Outcome Measures

Primary Outcomes (1)

  • Electrographic Seizure Occurrence

    Percentage of subjects who experience electrographic seizures.

    3 days

Secondary Outcomes (4)

  • Safety - Mortality

    5 days

  • Safety - Occurrence of Cardiopulmonary adverse effects

    5 days

  • Safety - Occurrence of Organ Dysfunction

    5 days

  • Safety -Occurrence of Hospital Acquired Infections

    5 days

Study Arms (1)

Cohort

Critically ill child undergoing clinically indicated EEG monitoring and electrographic seizure management.

Other: Clinically indicated EEG monitoring.

Interventions

Clinically indicated EEG monitoring.OTHER

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

Cohort

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This study is a prospective observational study of consecutive patients undergoing clinically indicated EEG monitoring in the Children's Hospital of Philadelphia Pediatric ICU as guided by an institutional ICU EEG Monitoring Pathway. Each subject will participate from the time of EEG monitoring initiation until the time of hospital discharge. This duration will generally be from several days to several weeks depending on the duration of the hospitalization.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (10)

  • 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: 31538340BACKGROUND

  • 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: 32077099BACKGROUND

  • 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: 38194638BACKGROUND

  • 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: 38079254BACKGROUND

  • 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: 36893385BACKGROUND

  • 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: 35512186BACKGROUND

  • 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: 34642942BACKGROUND

  • 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: 33893203BACKGROUND

  • Fung FW, Parikh DS, Jacobwitz M, Vala L, Donnelly M, Wang Z, Xiao R, Topjian AA, Abend NS. Validation of a model to predict electroencephalographic seizures in critically ill children. Epilepsia. 2020 Dec;61(12):2754-2762. doi: 10.1111/epi.16724. Epub 2020 Oct 16.

    PMID: 33063870BACKGROUND

  • Fung FW, Fan J, Vala L, Jacobwitz M, Parikh DS, Donnelly M, Topjian AA, Xiao R, Abend NS. EEG monitoring duration to identify electroencephalographic seizures in critically ill children. Neurology. 2020 Sep 15;95(11):e1599-e1608. doi: 10.1212/WNL.0000000000010421. Epub 2020 Jul 20.

    PMID: 32690798BACKGROUND

MeSH Terms

Conditions

SeizuresStatus Epilepticus

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicholas S Abend, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas S Abend, MD

CONTACT

215-590-1719abend@chop.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2018

First Posted

February 1, 2018

Study Start

March 13, 2017

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

February 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)