Health TrialsbyHealthPanel

Electrographic Seizure Management and Neurobehavioral Outcomes in Critically Ill Children

ConditionSeizures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorChildren's Hospital of Philadelphia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Care in the Children's Hospital of Philadelphia Pediatric ICU.

Clinically indicated continuous EEG monitoring.

Age > 1 month to 18 years.

Disqualifiers

Admitted for Phase 2 (intracranial) EEG monitoring.

Intensivist expects to discontinue technological support in the next two days given underlying medical or neurological problems.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Clinically indicated EEG monitoring.

    Other intervention

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

Treatment groups

2,500 Participants
are divided into 1 treatment group
Group A: Cohort1 intervention

Trial outcomes

Primary outcomes

1

Electrographic Seizure Occurrence

Percentage of subjects who experience electrographic seizures.

Time frame
3 days

Secondary outcomes

1

Safety - Mortality

Percentage of subjects with mortality related to electrographic seizure management.

Time frame
5 days
2

Safety - Occurrence of Cardiopulmonary adverse effects

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.

Time frame
5 days
3

Safety - Occurrence of Organ Dysfunction

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).

Time frame
5 days
4

Safety -Occurrence of Hospital Acquired Infections

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.

Time frame
5 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Philadelphia

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Source ClinicalTrials.gov
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