Electrographic Seizure Management and Neurobehavioral Outcomes in Critically Ill Children

Recruiting

• Conditions: Seizures
• Interventions: Other: Clinically indicated EEG monitoring.

• Registration Number: NCT03419260
• Lead Sponsor: Children's Hospital of Philadelphia

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.

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.

Study Timeline

• Study Start: 2017-03-13
• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-01-31
• Study First Posted: 2018-02-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	Clinically indicated EEG monitoring.	Critically ill child undergoing clinically indicated EEG monitoring and electrographic seizure management.

Primary Outcome Measures

Name	Time	Method
Electrographic Seizure Occurrence	3 days	Percentage of subjects who experience electrographic seizures.

Secondary Outcome Measures

Name	Time	Method
Safety -Occurrence of Hospital Acquired Infections	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.
Safety - Mortality	5 days	Percentage of subjects with mortality related to electrographic seizure management.
Safety - Occurrence of Cardiopulmonary adverse effects	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.
Safety - Occurrence of Organ Dysfunction	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).

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States