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Remote EEG Device for Identification of Risk for Neonatal Seizures

Primary Purpose

Neonatal Encephalopathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epilog device
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Neonatal Encephalopathy

Eligibility Criteria

undefined - 30 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Remote EEG monitoring

Arm Description

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

Outcomes

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
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.
Time from initiation of monitoring with Epilog device to monitoring completion or conversion to formal prolonged EEG monitoring.

Secondary Outcome Measures

Full Information

First Posted
January 5, 2022
Last Updated
April 19, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05239585
Brief Title
Remote EEG Device for Identification of Risk for Neonatal Seizures
Official Title
Pilot Study on the Use of a Wearable Remote Electroencephalography Device to Identify Neonates at Risk for Neonatal Seizures and Status Epilepticus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Encephalopathy

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remote EEG monitoring
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Epilog device
Intervention Description
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 Measure Information:
Title
Evaluate the effectiveness of the Epilog device in identification of neonates who are at risk for seizures and need formal EEG monitoring or cooling
Description
Total number of neonates that Epilog device identifies as requiring formal EEG monitoring
Time Frame
Approximately 2 to 72 hours
Title
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.
Description
Time from initiation of monitoring with Epilog device to monitoring completion or conversion to formal prolonged EEG monitoring.
Time Frame
Approximately 2 to 72 hours

10. Eligibility

Sex
All
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony L Fine, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Fine, MD
Phone
507-284-2511
Email
fine.anthony@mayo.edu

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Remote EEG Device for Identification of Risk for Neonatal Seizures

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