Status:
COMPLETED
Real-time State of Vigilance Monitor for the Neonatal Intensive Care Unit
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
University of Nebraska
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sleep Disturbance in Infancy (Disorder)
Neonatal Disease
Eligibility:
All Genders
1-1 years
Brief Summary
The goal of this observational study is to collect data to develop a complete package (hardware, user interface software and algorithms) that can monitor sleep-wake stages in neonates. Real-time EEG d...
Detailed Description
Use Case: Disruption of sleep is a common experience of hospitalized patients of all ages, especially if they are in an intensive care unit (ICU); infants in the NICU often stay weeks to months. The q...
Eligibility Criteria
Inclusion
- Admitted to the Newborn ICU in C\&W Mott Hospital
- \>/= 30 weeks gestational age at the time of birth (\>/= 33 weeks post-conceptional age at enrollment)
Exclusion
- Any diagnosis, patient care, or anticipated patient care that is likely to interfere with the 12 hour recording or would make the recording dangerous to the participant
Key Trial Info
Start Date :
September 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 19 2024
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04920175
Start Date
September 1 2021
End Date
December 19 2024
Last Update
January 24 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109