NCT02445417
Completed
Not Applicable
Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Encephalopathy
- Sponsor
- Sharp HealthCare
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- EEG recorded
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is early identification of asphyxiated newborns through eeg starting in the delivery room.
Detailed Description
There is a need for a reliable detector of birth asphyxia so that newborns with birth asphyxia can have timely and accurate diagnosis to receive therapeutic hypothermia within 6 hrs of life, which has been shown to significantly reduce deaths and improve long term developmental outcomes. This study is designed to record EEG during birth transition through the first 10 minutes of life.
Investigators
M J Harbert
Director of Neonatal Neurology
Sharp HealthCare
Eligibility Criteria
Inclusion Criteria
- •Term infants
- •Signed Informed consent
Exclusion Criteria
- •Known congenital anomalies
Outcomes
Primary Outcomes
EEG recorded
Time Frame: Birth to 10 minutes of life
May be up to 60 minutes if applicable
Secondary Outcomes
- Successful adhesion of EES to skin(60 minutes of life)
- Skin irritation from EES or hydrogel electrodes(60 minutes of life)
Study Sites (1)
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