Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-06 @ 12:29 PM
Study NCT ID:
NCT02605733
Status:
COMPLETED
Last Update Posted:
2021-12-13
First Post:
2015-10-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Neu-Prem Trial: Neuromonitoring of Preterm Newborn Brain During Birth Resuscitation
Sponsor:
Sharp HealthCare
Organization:
Study Overview
Official Title:
The Neu-Prem Trial: Neuromonitoring of Preterm Newborn Brain During Birth Resuscitation
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Neu-Prem
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: