Asphyxia Newborns, Encephalopathy
Conditions
Keywords
Perinatal depression
Brief summary
The purpose of this study is early identification of asphyxiated newborns through eeg starting in the delivery room.
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.
Interventions
None listed
Sponsors
The Hartwell Foundation
Sharp HealthCare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
36 Weeks to 44 Weeks
Healthy volunteers
Yes
Inclusion criteria
Term infants * Signed Informed consent
Exclusion criteria
* Known congenital anomalies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EEG recorded | Birth to 10 minutes of life | May be up to 60 minutes if applicable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin irritation from EES or hydrogel electrodes | 60 minutes of life | Redness, excoriation |
| Successful adhesion of EES to skin | 60 minutes of life | Redness, excoriation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Positive Pressure Ventilation | Birth to 10 minutes of life | By bag and mask or endotracheal tube |
| Continuous Positive Airway Pressure | Birth to 10 minutes of life | — |
| Epinephrine administration | Birth to 10 minutes of life | — |
| Apgar scores | Birth to 10 minutes of life | At 1, 5, 10, 15 and 20 minutes of life if done |
| Normal saline bolus administration | Birth to 10 minutes of life | — |
| Chest compressions | Birth to 10 minutes of life | — |
| Near-infrared spectroscopy measurement | Birth to 10 minutes of life. May extend to 60 minutes of life if applicable. | Non-invasive brain tissue oximetry recording |
| Sodium bicarbonate administration | Birth to 10 minutes of life | — |
| Blowby oxygen at delivery | Birth to 10 minutes of life | — |
| Intubation at delivery | Birth to 10 minutes of life | for meconium suctioning or ventilation purposes |
Countries
United States
Outcome results
None listed