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

Sharp HealthCare

Status: Completed

Conditions: Neurologic Manifestations; Hypoxia-Ischemia, Brain; Premature Birth

Treatments: Device: NIRS; Device: EEG

Study type: Observational

Funder types: Other

Identifiers

NCT02605733

Neu-Prem

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 130 patients

Sex: All

Ages: Under 72 hours old

Volunteers: No Healthy Volunteers

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