Hypoxia-Ischemia, Brain, Neurologic Manifestations, Premature Birth
Conditions
Keywords
Premature infant, Amplitude integrated EEG, Near-infrared spectroscopy
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.
Interventions
DEVICEEEG
amplitude integrated electroencephalography
DEVICENIRS
regional tissue oximetry
Sponsors
The Gerber Foundation
Sharp HealthCare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 72 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NIRS | Birth to 72 hours of life | Cerebral tissue oxygen saturation (StO2), Near-infrared spectroscopy to measure brain perfusion |
| EEG | Birth to 72 hours of life | amplitude integrated EEG to measure brain activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apgar scores | 1, 5 and 10 minutes of life if applicable | 1 and 5 minute Apgar scores |
| Cord gases | Upon delivery | Arterial or venous pH (acid/base), base deficit |
| Resuscitation intervention | From birth to 10 minutes of life | Fraction of inspired oxygen (FiO2), cpap, positive pressure ventilation (PPV), intubations. |
| Maximum FiO2 | From birth to 10 minutes of life | Maximum FiO2 during resuscitation at birth |
| Maximum peak inspiratory pressure | From birth to 10 minutes of life | Peak inspiratory pressure of respiratory support |
| Heart rate | Birth to 72 hours of life | — |
| Heart rate by EKG during resuscitation (substudy) | Birth | A substudy of 40 infants will have EKG leads placed on newborns during resuscitation; 20 will have the display blinded, and 20 will have values available to the team. The amount of resuscitation (mean airway pressure FiO2 will be compared between groups). |
| Cardiac output | From neonatal intensive care unit (NICU) admission through 72 hours of life | — |
| 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 | Dopamine, dobutamine, epinephrine |
| Head Ultrasound | Within 24 hours of life and at approximately 72 hours of life | Cranial ultrasonography |
| MRI | From birth through discharge to home, up to 9 months of age | Presence of brain injury (e.g. intraventricular hemorrhage (IVH), (PVL) |
| Neurodevelopmental impairment at 2 year follow up | 18 to 30 months corrected gestational age | Neurodevelopmental assessment at 2 year corrected gestational age |
Countries
United States
Outcome results
None listed