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

Sharp HealthCare60 enrolled

Overview

The purpose of this study is early identification of asphyxiated newborns through eeg starting in the delivery room.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Encephalopathy Asphyxia Newborns

Eligibility

Sex: ALLMin age: 36 WeeksMax age: 44 WeeksHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Term infants * Signed Informed consent Exclusion Criteria: * Known congenital anomalies

Locations (1)

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, United States

Outcomes

Primary Outcomes

EEG recorded

May be up to 60 minutes if applicable

Time frame: Birth to 10 minutes of life

Secondary Outcomes

Skin irritation from EES or hydrogel electrodes

Redness, excoriation

Time frame: 60 minutes of life

Successful adhesion of EES to skin

Redness, excoriation

Time frame: 60 minutes of life

Data from ClinicalTrials.gov

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