Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
13 participants
OBSERVATIONAL
2015-01-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Epidermal Electronic System
EES, wireless tattoo electrode
No interventions assigned to this group
Hydrogel electrode
EKG electrode, looking at hairline placement of electrodes.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Parents signed informed consent
* CGA 44 weeks or less
Exclusion Criteria
1 Day
ALL
No
Sponsors
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The Gerber Foundation
OTHER
Sharp HealthCare
OTHER
Responsible Party
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M J Harbert
Director of Neonatal Neurology
Principal Investigators
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Mary J Harbert, MD
Role: PRINCIPAL_INVESTIGATOR
Sharp Mary Birch Hospital for Women & Newborns
Locations
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Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, United States
Countries
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References
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Tharp BR. Neonatal seizures and syndromes. Epilepsia. 2002;43 Suppl 3:2-10. doi: 10.1046/j.1528-1157.43.s.3.11.x.
Lawrence R, Inder T. Neonatal status epilepticus. Semin Pediatr Neurol. 2010 Sep;17(3):163-8. doi: 10.1016/j.spen.2010.06.010.
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.
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.
Nagarajan L, Ghosh S, Palumbo L. Ictal electroencephalograms in neonatal seizures: characteristics and associations. Pediatr Neurol. 2011 Jul;45(1):11-6. doi: 10.1016/j.pediatrneurol.2011.01.009.
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.
Young GB, Campbell VC. EEG monitoring in the intensive care unit: pitfalls and caveats. J Clin Neurophysiol. 1999 Jan;16(1):40-5. doi: 10.1097/00004691-199901000-00003.
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.
Volpe JJ. Neonatal Seizures in Neurology of the Newborn, 4th ed. Philadelphia: WB Sanders, 2001: 178-214.
Other Identifiers
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Epidermal Electronics
Identifier Type: -
Identifier Source: org_study_id
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