Neonatal Encephalopathy
Conditions
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.
Interventions
DEVICEEpilog 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
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 30 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effectiveness of the Epilog device in identification of neonates who are at risk for seizures and need formal EEG monitoring or cooling | Approximately 2 to 72 hours | 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. | Approximately 2 to 72 hours | Time from initiation of monitoring with Epilog device to monitoring completion or conversion to formal prolonged EEG monitoring. |
Countries
United States
Outcome results
None listed