Novel Epidermal Recording and Detection of Seizures

Terminated

• Conditions: Seizures; Encephalopathy; Asphyxiated Newborn

• Registration Number: NCT02451618
• Lead Sponsor: Sharp HealthCare

Brief Summary

For any newborn that exhibits possible seizure activity or has altered mental status of unknown etiology, continuous bedside EEG recording is the standard of care to detect subclinical seizure activity. The experimental aspect of this study will be the application of test electrodes (EES or EKG) to evaluate if the electrodes can be used to produce a continuous bedside recording of brain activity in the same manner as an EEG recording, while ideally producing less irritation of newborn skin than conventional EEG electrodes.

Detailed Description

Infants admitted to our NICU that require a standard EEG for clinical diagnosis will be approached for consent to test one of two new methods of EEG recording. Patients will be randomized to the new epidermal electronic system (EES) or the a hydrogel EKG electrode. All patients will continue to receive the standard of care EEG monitoring.

EES is slim new temporary tattoo technology that can easily be applied to the skin without requiring a technician or scrubbing and preparation as with standard EEG lead. The hydrogel EKG are FDA approved leads normally used to detect cardiac rhythm.

Specific Aims:

1. To compare the rate of detection of neonatal seizures between a new method of recording electrical brain rhythms (EES or EKG) and the current standard of care (EEG, or electroencephalography.)

2. To compare characterization of electrical brain activity between EES or EKG and EEG in the neonate.

Study Timeline

• Study Start: 2015-01-27
• Study First Submitted: 2015-03-31
• Study First Submitted QC: 2015-05-21
• Study First Posted: 2015-05-22
• Primary Completion: 2017-11-03
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Hospitalized neonates who already require continuous EEG recording for clinical care
• Parents signed informed consent
• CGA 44 weeks or less

Exclusion Criteria

• Patient is moribund

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seizure detection	24 hours	Seizures detected by study electrodes will be compared to seizures detected on conventional EEG recording.

Secondary Outcome Measures

Name	Time	Method
EEG characterization	24 hours	Compare quality of brain activity with study leads vs standard leads
Skin integrity from standard EEG vs study electrodes	24 hours	Photographs will be taken to compare skin integrity after each electrode use.
Hair removal from standard EEG vs study electrodes	24 hours	If hair removal is necessary for study electrode placement.

Trial Locations

Locations (1)

Sharp Mary Birch Hospital for Women and Newborns; 🇺🇸 San Diego, California, United States