Remote EEG Device for Identification of Risk for Neonatal Seizures

Mayo Clinic

Status: Withdrawn

Conditions: Neonatal Encephalopathy

Treatments: Device: Epilog device

Study type: Interventional

Funder types: Other

Identifiers

NCT05239585

21-006001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: Under 30 days old

Volunteers: No 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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Remote EEG monitoring

Experimental group

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

Treatment:

Device: Epilog device