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Device

Remote EEG Device for Neonatal Seizures

N/A

Waitlist Available

Led By Anthony L Fine, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 28 days old or less (postnatal age)

Patient currently in level 1 newborn nursery or level 2 or 3 NICU

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 to 72 hours

Awards & highlights

Study Summary

This trial will test if wireless brain wave monitoring can help newborns by identifying seizures earlier and monitoring for the risk of seizures.

Who is the study for?

This trial is for newborns up to 28 days old who may have brain conditions or are at risk of seizures. They should be in a level 1 nursery or higher NICU. Newborns with other serious medical issues requiring long sedation, or those needing extended EEG monitoring for medical reasons cannot participate.Check my eligibility

What is being tested?

The study is testing the Epilog device, a wireless tool that monitors brain waves (EEG) to detect and assess the risk of seizures in newborn babies more quickly than current methods.See study design

What are the potential side effects?

Since this trial involves non-invasive monitoring with an EEG device, there are minimal expected side effects. However, skin irritation from electrode placement could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My baby is less than 28 days old.

Select...

My newborn is in a level 1, 2, or 3 NICU.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 2 to 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 2 to 72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 to 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluate the effectiveness of the Epilog device in identification of neonates who are at risk for seizures and need formal EEG monitoring or cooling

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.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Remote EEG monitoringExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,205 Previous Clinical Trials

3,766,774 Total Patients Enrolled

Anthony L Fine, MDPrincipal InvestigatorMayo Clinic

Media Library

Epilog device (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05239585 — N/A

Neonatal Encephalopathy Research Study Groups: Remote EEG monitoring

Neonatal Encephalopathy Clinical Trial 2023: Epilog device Highlights & Side Effects. Trial Name: NCT05239585 — N/A

Epilog device (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05239585 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any additional volunteers being sought for this clinical trial?

"It appears that the clinical trial, which was initially posted on January 1st of 2023 and recently updated on October 19th 2022, is no longer actively recruiting patients. However, there are still 224 different medical studies searching for participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Remote EEG Device for Identification of Risk for Neonatal Seizures

Anthony L. Fine, MD 2024. "Remote EEG Device for Identification of Risk for Neonatal Seizures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05239585.