NCT05239585

Remote EEG Device for Identification of Risk for Neonatal Seizures

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 30 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Neonatal Encephalopathy

Interventions

Type	Name	Description
DEVICE	Epilog device	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

Timeline

• Start date: 2024-08-15
• Primary completion: 2024-08-15
• Completion: 2024-08-15
• First posted: 2022-02-15
• Last updated: 2024-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study