Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury

Completed

• Conditions: Encephalopathy; Asphyxia Newborns

• Registration Number: NCT02445417
• Lead Sponsor: Sharp HealthCare

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.

Study Timeline

• Study First Submitted: 2015-03-31
• Study First Submitted QC: 2015-05-12
• Study First Posted: 2015-05-15
• Study Start: 2015-06-25
• Primary Completion: 2017-08-31
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Term infants

• Signed Informed consent

Exclusion Criteria

• Known congenital anomalies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EEG recorded	Birth to 10 minutes of life	May be up to 60 minutes if applicable

Secondary Outcome Measures

Name	Time	Method
Skin irritation from EES or hydrogel electrodes	60 minutes of life	Redness, excoriation
Successful adhesion of EES to skin	60 minutes of life	Redness, excoriation

Trial Locations

Locations (1)

Sharp Mary Birch Hospital for Women and Newborns; 🇺🇸 San Diego, California, United States