Remote EEG Device for Identification of Risk for Neonatal Seizures

NCT05239585 | Withdrawn FDA Device

• 1 other identifier: 21-006001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Encephalopathy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Remote EEG monitoring

EXPERIMENTAL

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

Interventions

Epilog device 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

Remote EEG monitoring

Eligibility Criteria

• Age: Up to 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Anthony L Fine, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 15, 2022
• Study Start: August 15, 2024
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

US (1)