Asphyxiated Newborn, Encephalopathy, Seizures
Conditions
Keywords
Perinatal Depression
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.
Interventions
None listed
Sponsors
The Gerber Foundation
Sharp HealthCare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seizure detection | 24 hours | Seizures detected by study electrodes will be compared to seizures detected on conventional EEG recording. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hair removal from standard EEG vs study electrodes | 24 hours | If hair removal is necessary for study electrode placement. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Apgar scores | Birth to 10 minutes of life | Apgars at 1, 5, 10, 15, and 20 minutes of life if applicable |
| Gestational age | At birth | — |
| Subject received hypothermia treatment within 6 hours of life | Within 6 hours of life for 72 hours duration | — |
| Cause of seizure if known | Participants will be followed for the duration of hospital stay, an average of 10 days. | Date and time of seizures and etiology |
| Anticonvulsant medication(s) subject received | Participants will be followed for the duration of hospital stay, an average of 10 days. | Phenobarbital, Levetiracetam, Phosphenytoin, Versed, Blinded Study Drug, Other |
Countries
United States
Outcome results
None listed