The Neu-Prem Trial: Neuromonitoring of Preterm Newborn Brain During Birth Resuscitation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Neurologic Manifestations
- Sponsor
- Sharp HealthCare
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- EEG
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Anup Katheria, M.D.
Director of Neonatal Research
Sharp HealthCare
Eligibility Criteria
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
Outcomes
Primary Outcomes
EEG
Time Frame: Birth to 72 hours of life
amplitude integrated EEG to measure brain activity
NIRS
Time Frame: Birth to 72 hours of life
Cerebral tissue oxygen saturation (StO2), Near-infrared spectroscopy to measure brain perfusion
Secondary Outcomes
- Maximum FiO2(From birth to 10 minutes of life)
- Heart rate(Birth to 72 hours of life)
- Cardiac output(From neonatal intensive care unit (NICU) admission through 72 hours of life)
- Head Ultrasound(Within 24 hours of life and at approximately 72 hours of life)
- MRI(From birth through discharge to home, up to 9 months of age)
- Neurodevelopmental impairment at 2 year follow up(18 to 30 months corrected gestational age)
- Apgar scores(1, 5 and 10 minutes of life if applicable)
- Cord gases(Upon delivery)
- Resuscitation intervention(From birth to 10 minutes of life)
- Maximum peak inspiratory pressure(From birth to 10 minutes of life)
- Heart rate by EKG during resuscitation (substudy)(Birth)
- Mean arterial blood pressure(From NICU admission through 72 hours of life)
- Use of cardiac inotropes(From birth through discharge to home, up to 9 months of age)