Novel Epidermal Recording and Detection of Seizures

Study Overview
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Brief Summary
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For any newborn that exhibits possible seizure activity or has altered mental status of unknown etiology, continuous bedside EEG recording is the standard of care to detect subclinical seizure activity. The experimental aspect of this study will be the application of test electrodes (EES or EKG) to evaluate if the electrodes can be used to produce a continuous bedside recording of brain activity in the same manner as an EEG recording, while ideally producing less irritation of newborn skin than conventional EEG electrodes.

Detailed Description
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Infants admitted to our NICU that require a standard EEG for clinical diagnosis will be approached for consent to test one of two new methods of EEG recording. Patients will be randomized to the new epidermal electronic system (EES) or the a hydrogel EKG electrode. All patients will continue to receive the standard of care EEG monitoring. EES is slim new temporary tattoo technology that can easily be applied to the skin without requiring a technician or scrubbing and preparation as with standard EEG lead. The hydrogel EKG are FDA approved leads normally used to detect cardiac rhythm. Specific Aims: To compare the rate of detection of neonatal seizures between a new method of recording electrical brain rhythms (EES or EKG) and the current standard of care (EEG, or electroencephalography.) To compare characterization of electrical brain activity between EES or EKG and EEG in the neonate.

Official Title
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A Pilot Study of Seizure Detection in Neonates Using Multimodal Temporary Epidermal Electronics

Conditions
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Seizures, Encephalopathy, Asphyxiated Newborn

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized neonates who already require continuous EEG recording for clinical care Parents signed informed consent CGA 44 weeks or less Exclusion Criteria: Patient is moribund

Ages Eligible for Study
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Minimum Age: 1 Day

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Epidermal Electronic System<br>EES, wireless tattoo electrode | |
| Hydrogel electrode<br>EKG electrode, looking at hairline placement of electrodes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure detection | Seizures detected by study electrodes will be compared to seizures detected on conventional EEG recording. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG characterization | Compare quality of brain activity with study leads vs standard leads | 24 hours | 
| Skin integrity from standard EEG vs study electrodes | Photographs will be taken to compare skin integrity after each electrode use. | 24 hours | 
| Hair removal from standard EEG vs study electrodes | If hair removal is necessary for study electrode placement. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perinatal Depression