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OpenTrials
Completed

NCT Number: NCT02445417

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

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

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Key information

Conditions

Encephalopathy Asphyxia Neonatorum Asphyxia Newborns Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Nervous System Diseases

Age range

36 week–44 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Term infants

  • Signed Informed consent

Exclusion criteria

  • Known congenital anomalies

Treatment and study plan

Primary outcomes

  1. EEG recorded

    Time frame: Birth to 10 minutes of life

    May be up to 60 minutes if applicable

Secondary outcomes

  1. Skin irritation from EES or hydrogel electrodes

    Time frame: 60 minutes of life

    Redness, excoriation

  2. Successful adhesion of EES to skin

    Time frame: 60 minutes of life

    Redness, excoriation

Other outcomes

  1. Apgar scores

    Time frame: Birth to 10 minutes of life

    At 1, 5, 10, 15 and 20 minutes of life if done

  2. Blowby oxygen at delivery

    Time frame: Birth to 10 minutes of life

  3. Intubation at delivery

    Time frame: Birth to 10 minutes of life

    for meconium suctioning or ventilation purposes

  4. Positive Pressure Ventilation

    Time frame: Birth to 10 minutes of life

    By bag and mask or endotracheal tube

  5. Continuous Positive Airway Pressure

    Time frame: Birth to 10 minutes of life

  6. Epinephrine administration

    Time frame: Birth to 10 minutes of life

  7. Sodium bicarbonate administration

    Time frame: Birth to 10 minutes of life

  8. Normal saline bolus administration

    Time frame: Birth to 10 minutes of life

  9. Chest compressions

    Time frame: Birth to 10 minutes of life

  10. Near-infrared spectroscopy measurement

    Time frame: Birth to 10 minutes of life. May extend to 60 minutes of life if applicable.

    Non-invasive brain tissue oximetry recording

Sponsors and collaborators

Lead sponsor

Sharp HealthCare

Other

Collaborators

  • The Hartwell Foundation

Registry information

Important dates

Study start
2015
Primary completion
2017
First posted
May 15, 2015
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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