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microEEG for Neonatal Apnea, Bradycardia and Desaturation

NCT02436616 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2016-02-29

No results posted yet for this study

Summary

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.

Conditions

  • Apnea
  • Bradycardia
  • Premature Birth
  • Seizures

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.

Sponsors & Collaborators

  • State University of New York - Downstate Medical Center

    collaborator OTHER

  • Brookdale University Hospital Medical Center

    collaborator OTHER

  • Bio-Signal Group Corp.

    lead INDUSTRY

Principal Investigators

  • Zachary Ibrahim, MD · State University of New York - Downstate Medical Center

Eligibility

Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-06-30
Completion
2016-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02436616 on ClinicalTrials.gov