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

S

Sharp HealthCare

Status

Completed

Conditions

Encephalopathy
Asphyxia Newborns

Study type

Observational

Funder types

Other

Identifiers

NCT02445417
Transition

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

36 to 44 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Term infants

  • Signed Informed consent

Exclusion Criteria:

  • Known congenital anomalies

Trial design

60 participants in 2 patient groups

EES
Description:
Epidermal Electronic System
Hydrogel Electrode
Description:
Hydrogel based EEG electrode

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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