Novel Epidermal Recording and Detection of Seizures (NERDS)

Sharp HealthCare

Status: Terminated

Conditions: Seizures; Encephalopathy; Asphyxiated Newborn

Study type: Observational

Funder types: Other

Identifiers

NCT02451618

Epidermal Electronics

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 1+ day old

Volunteers: No Healthy Volunteers

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

Trial design

13 participants in 2 patient groups

Epidermal Electronic System

Description:

EES, wireless tattoo electrode

Hydrogel electrode

Description:

EKG electrode, looking at hairline placement of electrodes.