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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02445417
Recruitment Status : Completed
First Posted : May 15, 2015
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
The Hartwell Foundation
Information provided by (Responsible Party):
M J Harbert, Sharp HealthCare

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

Condition or disease
Encephalopathy Asphyxia Newborns

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.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury
Actual Study Start Date : June 25, 2015
Actual Primary Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
EES
Epidermal Electronic System
Hydrogel Electrode
Hydrogel based EEG electrode



Primary Outcome Measures :
  1. EEG recorded [ Time Frame: Birth to 10 minutes of life ]
    May be up to 60 minutes if applicable


Secondary Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   36 Weeks to 44 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Term infants at delivery (37-44 weeks gestational age)
Criteria

Inclusion Criteria: Term infants

  • Signed Informed consent

Exclusion Criteria:

  • Known congenital anomalies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445417


Locations
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United States, California
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, United States, 92123
Sponsors and Collaborators
Sharp HealthCare
The Hartwell Foundation
Investigators
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Principal Investigator: Mary J Harbert, MD Sharp Mary Birch Hospital for Women & Newborns
Additional Information:
Publications:

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Responsible Party: M J Harbert, Director of Neonatal Neurology, Sharp HealthCare
ClinicalTrials.gov Identifier: NCT02445417    
Other Study ID Numbers: Transition
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Keywords provided by M J Harbert, Sharp HealthCare:
Perinatal depression
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Asphyxia
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Death
Pathologic Processes