Remote EEG Device for Identification of Risk for Neonatal Seizures

Neonatal Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05239585
• Other study ID #: 21-006001
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: January 2026

Study information

• Verified date: April 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Neonatal Encephalopathy
• Seizures

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Mayo Clinic Clinical Trials