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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: EEG
* Device: NIRS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 72 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: EEG|amplitude integrated electroencephalography|
|Device: NIRS|regional tissue oximetry|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG | amplitude integrated EEG to measure brain activity | Birth to 72 hours of life | 
| NIRS | Cerebral tissue oxygen saturation (StO2), Near-infrared spectroscopy to measure brain perfusion | Birth to 72 hours of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apgar scores | 1 and 5 minute Apgar scores | 1, 5 and 10 minutes of life if applicable | 
| Cord gases | Arterial or venous pH (acid/base), base deficit | Upon delivery | 
| Resuscitation intervention | Fraction of inspired oxygen (FiO2), cpap, positive pressure ventilation (PPV), intubations. | From birth to 10 minutes of life | 
| Maximum FiO2 | Maximum FiO2 during resuscitation at birth | From birth to 10 minutes of life | 
| Maximum peak inspiratory pressure | Peak inspiratory pressure of respiratory support | From birth to 10 minutes of life | 
| Heart rate |  | Birth to 72 hours of life | 
| Heart rate by EKG during resuscitation (substudy) | 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). | Birth | 
| 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 | Dopamine, dobutamine, epinephrine | From birth through discharge to home, up to 9 months of age | 
| Head Ultrasound | Cranial ultrasonography | Within 24 hours of life and at approximately 72 hours of life | 
| MRI | Presence of brain injury (e.g. intraventricular hemorrhage (IVH), (PVL) | From birth through discharge to home, up to 9 months of age | 
| Neurodevelopmental impairment at 2 year follow up | Neurodevelopmental assessment at 2 year corrected gestational age | 18 to 30 months corrected gestational age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature infant, Amplitude integrated EEG, Near-infrared spectroscopy