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

Completed

• Conditions: Premature Birth; Neurologic Manifestations; Hypoxia-Ischemia, Brain

• Registration Number: NCT02605733
• Lead Sponsor: Sharp HealthCare

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-30
• Study First Submitted QC: 2015-11-12
• Study First Posted: 2015-11-16
• Primary Completion: 2016-12-31
• Study Completion: 2021-05-13
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EEG	Birth to 72 hours of life	amplitude integrated EEG to measure brain activity
NIRS	Birth to 72 hours of life	Cerebral tissue oxygen saturation (StO2), Near-infrared spectroscopy to measure brain perfusion

Secondary Outcome Measures

Name	Time	Method
Maximum FiO2	From birth to 10 minutes of life	Maximum FiO2 during resuscitation at birth
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	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
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 peak inspiratory pressure	From birth to 10 minutes of life	Peak inspiratory pressure of respiratory support
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).
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

Trial Locations

Locations (1)

Sharp Mary Birch Hospital for Women and Newborns; 🇺🇸 San Diego, California, United States