The Neu-Prem Trial: Neuromonitoring of Preterm Newborn Brain During Birth Resuscitation



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease, Neurology, Women's Studies
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology, Reproductive
Healthy:No
Age Range:Any
Updated:11/30/2018
Start Date:October 2015
End Date:July 2019

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Trial Summary
Trial Overview
Inclusion Criteria
The purpose of this study is to characterize the normal brain function of premature infants
(23 to 31+6 weeks GA) during birth transition and through the first 72 hours of life.

The investigators will measure components of brain function using two sophisticated,
non-invasive technologies. First, amplitude integrated electroencephalography (EEG), a
"simplified" EEG with four sensors (single channel), enables continuous non-invasive
monitoring of cerebral activity. Second, near-infrared spectroscopy (NIRS) is another
non-invasive technology that allows continuous real-time measurement of regional tissue
oxygen utilization of the brain. Both technologies have been used in newborns and have been
predictive of brain injury or neurodevelopmental impairment.

Inclusion Criteria:

- 23 to 31+6 weeks gestational age at birth

Exclusion Criteria:

- Known congenital anomalies

- Parents refuse consent

- Neonatologist declined due to subject instability
We found this trial at
1
site
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California 92123
Principal Investigator: Anup Katheria, MD
Phone: 858-939-4198
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mi
from
San Diego, CA
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