Remote EEG Device for Identification of Risk for Neonatal Seizures

Not Applicable

Withdrawn

• Conditions: Neonatal Encephalopathy
• Interventions: Device: Epilog device

• Registration Number: NCT05239585
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-02-03
• Study First Posted: 2022-02-15
• Status Verified: 2024-08
• Study Start: 2024-08-15
• Primary Completion: 2024-08-15
• Study Completion: 2024-08-15
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

• Medical comorbidity which would result in prolonged need for sedation
• Prolonged EEG monitoring is medically indicated

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Remote EEG monitoring	Epilog device	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

Primary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of the Epilog device in identification of neonates who are at risk for seizures and need formal EEG monitoring or cooling	Approximately 2 to 72 hours	Total number of neonates that Epilog device identifies as requiring formal EEG monitoring
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.	Approximately 2 to 72 hours	Time from initiation of monitoring with Epilog device to monitoring completion or conversion to formal prolonged EEG monitoring.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States