Clinical Trial: Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury

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

Detailed Summary:

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.


Sponsor: Sharp HealthCare

Current Primary Outcome: EEG recorded [ Time Frame: Birth to 10 minutes of life ]

May be up to 60 minutes if applicable


Original Primary Outcome:

  • Successful adhesion of EES to skin [ Time Frame: Birth to 10 minutes of life ]
    Ultra thin fluid resistant medical adhesive with thin electric circuitry embedded
  • EEG recorded [ Time Frame: Birth to 10 minutes of life ]
    May be up to 60 minutes if applicable


Current Secondary Outcome:

  • Skin irritation from EES or hydrogel electrodes [ Time Frame: 60 minutes of life ]
    Redness, excoriation
  • Successful adhesion of EES to skin [ Time Frame: 60 minutes of life ]
    Redness, excoriation


Original Secondary Outcome: Skin irritation from EES or hydrogel electrodes [ Time Frame: 60 minutes of life ]

Redness, excoriation


Information By: Sharp HealthCare

Dates:
Date Received: March 31, 2015
Date Started: May 2015
Date Completion: November 2018
Last Updated: November 8, 2016
Last Verified: November 2016