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Trial was discontinued due to inadequate signal from study eeg leads.
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| Name | Class |
|---|---|
| The Gerber Foundation | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidermal Electronic System | EES, wireless tattoo electrode | ||
| Hydrogel electrode | EKG electrode, looking at hairline placement of electrodes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Seizure detection | Seizures detected by study electrodes will be compared to seizures detected on conventional EEG recording. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| EEG characterization | Compare quality of brain activity with study leads vs standard leads | 24 hours |
| Skin integrity from standard EEG vs study electrodes | Photographs will be taken to compare skin integrity after each electrode use. |
| Measure | Description | Time Frame |
|---|---|---|
| Apgar scores | Apgars at 1, 5, 10, 15, and 20 minutes of life if applicable | Birth to 10 minutes of life |
| Subject received hypothermia treatment within 6 hours of life | Within 6 hours of life for 72 hours duration |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Mary J Harbert, MD | Sharp Mary Birch Hospital for Women & Newborns | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Mary Birch Hospital for Women and Newborns | San Diego | California | 92123 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12060001 | Background | Tharp BR. Neonatal seizures and syndromes. Epilepsia. 2002;43 Suppl 3:2-10. doi: 10.1046/j.1528-1157.43.s.3.11.x. | |
| 20727485 | Background | Lawrence R, Inder T. Neonatal status epilepticus. Semin Pediatr Neurol. 2010 Sep;17(3):163-8. doi: 10.1016/j.spen.2010.06.010. |
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| ID | Term |
|---|---|
| D012640 | Seizures |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 24 hours |
| Hair removal from standard EEG vs study electrodes | If hair removal is necessary for study electrode placement. | 24 hours |
| Cause of seizure if known | Date and time of seizures and etiology | Participants will be followed for the duration of hospital stay, an average of 10 days. |
| Anticonvulsant medication(s) subject received | Phenobarbital, Levetiracetam, Phosphenytoin, Versed, Blinded Study Drug, Other | Participants will be followed for the duration of hospital stay, an average of 10 days. |
| Gestational age | At birth |
| 20384780 | Background | 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. |
| 20100767 | Background | 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. |
| 21723453 | Background | 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. |
| 11222977 | Background | 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. |
| 10082090 | Background | 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. |
| 21836009 | Background | 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. |
| Background | Volpe JJ. Neonatal Seizures in Neurology of the Newborn, 4th ed. Philadelphia: WB Sanders, 2001: 178-214. |
| D002493 | Central Nervous System Diseases |