microEEG for Neonatal Apnea, Bradycardia and Desaturation

UnknownOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

June 30, 2016

Study Completion Date

July 31, 2016

Conditions
ApneaBradycardiaPremature BirthSeizures
Interventions
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."

Trial Locations (2)

11203

RECRUITING

State University of New York/Downstate Medical Center, Brooklyn

11212

RECRUITING

Brookdale University Hospital and Medical Center,, Brooklyn

Sponsors
All Listed Sponsors
collaborator

State University of New York - Downstate Medical Center

OTHER

collaborator

Brookdale University Hospital Medical Center

OTHER

lead

Bio-Signal Group Corp.

INDUSTRY

NCT02436616 - microEEG for Neonatal Apnea, Bradycardia and Desaturation | Biotech Hunter | Biotech Hunter