Premature Birth Clinical Trial
Official title:
Wireless Novel microEEG for Neonatal Apnea and Community Neurological Network
The study utilizes microEEG (a novel miniaturized, FDA approved EEG device) to prospectively investigate the cerebral electrical activity of infants with Apnea, Bradycardia and Desaturation events. This project will also assess the feasibility of using the microEEG device in the Neonatal Intensive Care Unit (NICU) setting and the feasibility of remote centralized interpretation in this setting.
Most preterm infants have episodes of apnea (cessation of breathing), bradycardia (low heart
rate), and desaturations (low levels of oxygen in the blood) (ABD events). The resolution of
ABD episodes depends to a large extent on the maturation of the central nervous system
(CNS). The electroencephalogram (EEG) is a reliable and noninvasive tool for recording the
electrical activity of the CNS. The relationship between ABD events and cerebral electrical
activity has not been well investigated. The investigators seek to examine the relationship
between EEG findings and the resolution of ABD events in the developing premature infant.
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.
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