Clinical trial NCT02451618: Novel Epidermal Recording and Detection of Seizures
Official title: A Pilot Study of Seizure Detection in Neonates Using Multimodal Temporary Epidermal Electronics
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Seizures
Encephalopathy
Asphyxiated Newborn
Keywords: Perinatal Depression
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
First posted: 2015-05-22
Enrollment: 13
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any newborn admitted to the NICU that requires an EEG for clinical care. Must be less than or equal to 44 weeks corrected gestational age.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Seizure detection
timeFrame: 24 hours
Secondary outcomes:
measure: EEG characterization
timeFrame: 24 hours
measure: Skin integrity from standard EEG vs study electrodes
timeFrame: 24 hours
measure: Hair removal from standard EEG vs study electrodes
timeFrame: 24 hours
Other outcomes:
measure: Apgar scores
timeFrame: Birth to 10 minutes of life
measure: Subject received hypothermia treatment within 6 hours of life
timeFrame: Within 6 hours of life for 72 hours duration
measure: Cause of seizure if known
timeFrame: Participants will be followed for the duration of hospital stay, an average of 10 days.
measure: Anticonvulsant medication(s) subject received
timeFrame: Participants will be followed for the duration of hospital stay, an average of 10 days.
measure: Gestational age
timeFrame: At birth
Locations:
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
Study officials:
affiliation: Sharp Mary Birch Hospital for Women & Newborns
name: Mary J Harbert, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Isaeva E, Isaev D, Savrasova A, Khazipov R, Holmes GL. Recurrent neonatal seizures result in long-term increases in neuronal network excitability in the rat neocortex. Eur J Neurosci. 2010 Apr;31(8):1446-55. doi: 10.1111/j.1460-9568.2010.07179.x. Epub 2010 Apr 6.
citation: van Rooij LG, Toet MC, van Huffelen AC, Groenendaal F, Laan W, Zecic A, de Haan TR, van Straaten IL, Vrancken S, van Wezel G, van der Sluijs J, Ter Horst H, Gavilanes D, Laroche S, Naulaers G, de Vries LS. Effect of treatment of subclinical neonatal seizures detected with aEEG: randomized, controlled trial. Pediatrics. 2010 Feb;125(2):e358-66. doi: 10.1542/peds.2009-0136. Epub 2010 Jan 25.
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citation: Ferree TC, Luu P, Russell GS, Tucker DM. Scalp electrode impedance, infection risk, and EEG data quality. Clin Neurophysiol. 2001 Mar;112(3):536-44. doi: 10.1016/s1388-2457(00)00533-2.
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citation: Kim DH, Lu N, Ma R, Kim YS, Kim RH, Wang S, Wu J, Won SM, Tao H, Islam A, Yu KJ, Kim TI, Chowdhury R, Ying M, Xu L, Li M, Chung HJ, Keum H, McCormick M, Liu P, Zhang YW, Omenetto FG, Huang Y, Coleman T, Rogers JA. Epidermal electronics. Science. 2011 Aug 12;333(6044):838-43. doi: 10.1126/science.1206157.
citation: Volpe JJ. Neonatal Seizures in Neurology of the Newborn, 4th ed. Philadelphia: WB Sanders, 2001: 178-214.