Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury
NCT ID: NCT02445417
Last Updated: 2018-09-07
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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COMPLETED
60 participants
OBSERVATIONAL
2015-06-25
Brief Summary
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Detailed Description
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This study is designed to record EEG during birth transition through the first 10 minutes of life.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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EES
Epidermal Electronic System
No interventions assigned to this group
Hydrogel Electrode
Hydrogel based EEG electrode
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
36 Weeks
44 Weeks
ALL
Yes
Sponsors
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The Hartwell 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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Raghuveer TS, Cox AJ. Neonatal resuscitation: an update. Am Fam Physician. 2011 Apr 15;83(8):911-8.
Perez A, Ritter S, Brotschi B, Werner H, Caflisch J, Martin E, Latal B. Long-term neurodevelopmental outcome with hypoxic-ischemic encephalopathy. J Pediatr. 2013 Aug;163(2):454-9. doi: 10.1016/j.jpeds.2013.02.003. Epub 2013 Mar 14.
Massaro AN, Tsuchida T, Kadom N, El-Dib M, Glass P, Baumgart S, Chang T. aEEG evolution during therapeutic hypothermia and prediction of NICU outcome in encephalopathic neonates. Neonatology. 2012;102(3):197-202. doi: 10.1159/000339570. Epub 2012 Jul 12.
Jacobs SE, Berg M, Hunt R, Tarnow-Mordi WO, Inder TE, Davis PG. Cooling for newborns with hypoxic ischaemic encephalopathy. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD003311. doi: 10.1002/14651858.CD003311.pub3.
Shalak LF, Laptook AR, Velaphi SC, Perlman JM. Amplitude-integrated electroencephalography coupled with an early neurologic examination enhances prediction of term infants at risk for persistent encephalopathy. Pediatrics. 2003 Feb;111(2):351-7. doi: 10.1542/peds.111.2.351.
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.
Pichler G, Avian A, Binder C, Zotter H, Schmolzer GM, Morris N, Muller W, Urlesberger B. aEEG and NIRS during transition and resuscitation after birth: promising additional tools; an observational study. Resuscitation. 2013 Jul;84(7):974-8. doi: 10.1016/j.resuscitation.2012.12.025. Epub 2013 Jan 8.
Other Identifiers
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Transition
Identifier Type: -
Identifier Source: org_study_id
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