Remote EEG Device for Identification of Risk for Neonatal Seizures

Study Overview
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Brief Summary
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The purpose of this study is to see if the use of wireless brain wave monitoring can be helpful for newborns and help their medical providers identify seizures earlier and to monitor for the risk for seizures.

Detailed Description
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Our goals are to evaluate the effectiveness of the Epilog device in identification of neonates who are at risk for seizures and need formal EEG monitoring or cooling. The current process for these patients would be transfer from Rochester Methodist Hospital to the St. Mary's level 3 NICU for EEG monitoring. Given that in case of neonatal encephalopathy, there is 6-hour window in which to make the critical decision of whether to initiate therapeutic hypothermia or not, rapid access to EEG data is crucial. We would like to perform a pilot study on use of wireless EEG technology in neonates with mild neonatal encephalopathy and neonates with spells to see if this device can be used to determine the risk for neonatal seizure and need for escalation of care and full scalp EEG.

Official Title
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Pilot Study on the Use of a Wearable Remote Electroencephalography Device to Identify Neonates at Risk for Neonatal Seizures and Status Epilepticus

Conditions
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Neonatal Encephalopathy

Intervention / Treatment
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* Device: Epilog device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 28 days old or less (postnatal age) Neonatal encephalopathy as judged by clinical team or symptoms concerning for subtle seizures Patient currently in level 1 newborn nursery or level 2 or 3 NICU Exclusion Criteria: Medical comorbidity which would result in prolonged need for sedation Prolonged EEG monitoring is medically indicated

Ages Eligible for Study
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Maximum Age: 30 Days

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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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote EEG monitoring<br>All subjects will pilot the use of wireless EEG technology in neonates with mild neonatal encephalopathy and neonates with spells to see if this device can be used to determine the risk for neonatal seizure and need for escalation of care and full scalp EEG | Device: Epilog device<br>* Pilot the use of wireless EEG technology in neonates with mild neonatal encephalopathy and neonates with spells to see if this device can be used to determine the risk for neonatal seizure and need for escalation of care and full scalp EEG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effectiveness of the Epilog device in identification of neonates who are at risk for seizures and need formal EEG monitoring or cooling | Total number of neonates that Epilog device identifies as requiring formal EEG monitoring | Approximately 2 to 72 hours | 
| Evaluate time to formal long-term EEG monitoring in neonates monitored with the Epilog device compared to a historical control cohort of neonates undergoing EEG evaluation. | Time from initiation of monitoring with Epilog device to monitoring completion or conversion to formal prolonged EEG monitoring. | Approximately 2 to 72 hours |