NCT02605733

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 130 (actual)
• Sponsor: Sharp HealthCare · Academic / Other
• Sex: All
• Age: 72 Hours
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Neurologic Manifestations
• Premature Birth
• Hypoxia-Ischemia, Brain

Interventions

Type	Name	Description
DEVICE	EEG	amplitude integrated electroencephalography
DEVICE	NIRS	regional tissue oximetry

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-12-31
• Completion: 2021-05-13
• First posted: 2015-11-16
• Last updated: 2021-12-13

Locations

1 site across 1 country: United States