microEEG for Neonatal Apnea, Bradycardia and Desaturation
NCT ID: NCT02436616
Last Updated: 2016-02-29
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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UNKNOWN
50 participants
OBSERVATIONAL
2013-01-31
2016-07-31
Brief Summary
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Detailed Description
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To investigate this relationship and obtain findings which are relevant to clinical care, a variety of obstacles need to be overcome. Among these obstacles is the high cost of standard EEG machines, inability of most standard machines to operate in electrically-noisy environments such as the NICU, and the absence of full-time coverage neurologists for prompt EEG interpretation. The investigators seek to determine the feasibility of obtaining an artifact-free EEG in the NICU with accurate detection of background rhythm abnormalities. The investigators will utilize an existing digital wireless telemetry unit, the "microEEG" for the NICU for this purpose. The microEEG device is specifically designed to overcome obstacles to standard EEG recording.
To address the shortage of trained pediatric neurophysiologists, the investigators will investigate the feasibility of a case management system for centralized EEG interpretation using off-site neurologists.
Finally, the investigators will examine the inter-rater reliability of EEG interpretation in the developing premature infant. This will allow the development of consensus guidelines for EEG interpretations.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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EEG monitoring
All subjects enrolled in this observational study will undergo EEG monitoring using the microEEG device.
microEEG
microEEG is a miniature, wireless, and battery-powered EEG device used to obtain EEG recording in challenging environment. All infants have an initial EEG at study enrollment. Follow up microEEGs will be performed at approximately 2-4 week intervals, depending on the Corrected Gestational Age (CGA).
If ABD events have not resolved at 34 weeks, an 8 hour recording will be performed prior to discharge or at 42 weeks CGA, whichever comes first. EEG will be assessed in 3 hour epochs. The EEG will be reviewed off line by two blinded neurologists and classified as normal or abnormal based on CGA and other findings. Follow up EEGs will be scored similarly, with emphasis on maturation.
Interventions
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microEEG
microEEG is a miniature, wireless, and battery-powered EEG device used to obtain EEG recording in challenging environment. All infants have an initial EEG at study enrollment. Follow up microEEGs will be performed at approximately 2-4 week intervals, depending on the Corrected Gestational Age (CGA).
If ABD events have not resolved at 34 weeks, an 8 hour recording will be performed prior to discharge or at 42 weeks CGA, whichever comes first. EEG will be assessed in 3 hour epochs. The EEG will be reviewed off line by two blinded neurologists and classified as normal or abnormal based on CGA and other findings. Follow up EEGs will be scored similarly, with emphasis on maturation.
Eligibility Criteria
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Inclusion Criteria
2. postnatal ages 0-30 days. The patients will be recruited upon manifesting one of the following
* apneas (cessation of breathing \> 10 seconds) x2 in a 12 hour span
* bradycardias (HR \< 100/min) x2 in 12 hours
* oxygen desaturations (\<80%) x 2 in 12 hours
* a single ABD event that does not resolve with stimulation or an increase in fractional oxygen delivery (FiO2).
Exclusion Criteria
2. The infant has exposed dermis on the scalp due to immaturity
3. Any scalp skin lesions such as pustules, large abrasions The patient will be Withdrawn if
* Informed consent is withdrawn
* adverse events (i.e..scalp lesions) develop
30 Days
ALL
No
Sponsors
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State University of New York - Downstate Medical Center
OTHER
Brookdale University Hospital Medical Center
OTHER
Bio-Signal Group Corp.
INDUSTRY
Responsible Party
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Principal Investigators
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Zachary Ibrahim, MD
Role: PRINCIPAL_INVESTIGATOR
State University of New York - Downstate Medical Center
Locations
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State University of New York/Downstate Medical Center
Brooklyn, New York, United States
Brookdale University Hospital and Medical Center,
Brooklyn, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Zachary Ibrahim, MD
Role: primary
Geetha Chari, MD
Role: backup
Roger Kim, MD
Role: primary
Related Links
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Abstract from International Chil Neurology Congress
Other Identifiers
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307016-7
Identifier Type: -
Identifier Source: org_study_id