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NCT Number: NCT03419260

Electrographic Seizure Management and Neurobehavioral Outcomes in Critically Ill Children

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.

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Nichoals S Abend, MD

CONTACT

215-590-1719

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Electrographic Seizure Occurrence

    Time frame: 3 days

    Percentage of subjects who experience electrographic seizures.

Secondary outcomes

  1. Safety - Mortality

    Time frame: 5 days

    Percentage of subjects with mortality related to electrographic seizure management.

  2. Safety - Occurrence of Cardiopulmonary adverse effects

    Time frame: 5 days

    Percentage of subjects with cardiopulmonary adverse effects related to electrographic seizure management. Cardiopulmonary problems include subcategories of anaphylactic reactions, bradycardia (<5th percentile for age), hypotension (<5th percentile for age), hypoxemia (saturation <90%), lactic acidosis (>2 mmol/l), and intubation requirement.

  3. Safety - Occurrence of Organ Dysfunction

    Time frame: 5 days

    Percentage of subjects with organ dysfunction adverse effects related to electrographic seizure management. Organ dysfunction that will include subcategories of allergic skin manifestations, acute kidney injury, hepatitis and acute liver injury, coagulopathy, and cytopenias (rbc, wbc, platelets).

  4. Safety -Occurrence of Hospital Acquired Infections

    Time frame: 5 days

    Percentage of subjects with hospital acquired infection adverse effects related to electrographic seizure management. Hospital acquired infections that will include subcategories of central line associated bloodstream infections, urinary tract infection, and ventilator associated pneumonia.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicholas S Abend, MD

CONTACT

[email protected]

215-590-1719

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2017
Primary completion
2028
Study completion
2028
First posted
Feb 1, 2018
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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