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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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 Summary: 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.
Sponsor: Sharp HealthCare

Current Primary Outcome:

  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Apgar scores [ Time Frame: 1, 5 and 10 minutes of life if applicable ]
  • Cord gases [ Time Frame: Upon delivery ]
    Arterial or venous pH (acid/base), base deficit
  • Resuscitation intervention [ Time Frame: From birth to 10 minutes of life ]
    Fraction of inspired oxygen (FiO2), cpap, positive pressure ventilation (PPV), intubations.
  • Maximum FiO2 [ Time Frame: From birth to 10 minutes of life ]
  • Maximum peak inspiratory pressure [ Time Frame: From birth to 10 minutes of life ]
  • Heart rate [ Time Frame: Birth to 72 hours of life ]
  • Heart rate by EKG during resuscitation (substudy) [ Time Frame: 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 [ Time Frame: From neonatal intensive care unit (NICU) admission through 72 hours of life ]
  • Mean arterial blood pressure [ Time Frame: From NICU admission through 72 hours of life ]
  • Use of cardiac inotropes [ Time Frame: From birth through discharge to home, up to 9 months of age ]
    Dopamine, dobutamine, epinephrine
  • Head Ultrasound [ Time Frame: Within 24 hours of life and at approximately 72 hours of life ]
  • MRI [ Time Frame: From birth through discharge to home, up to 9 months of age ]
    Presence of brain injury (e.g. intraventricular hemorrhage (IVH), (PVL)


Original Secondary Outcome:

  • Apgar scores [ Time Frame: 1, 5 and 10 minutes of life if applicable ]
  • Cord gases [ Time Frame: Upon delivery ]
    Arterial or venous pH (acid/base), base deficit
  • Resuscitation intervention [ Time Frame: From birth to 10 minutes of life ]
    Fraction of inspired oxygen (FiO2), cpap, positive pressure ventilation (PPV), intubation, chest compressions, volume, medications
  • Maximum FiO2 [ Time Frame: From birth to 10 minutes of life ]
  • Maximum peak inspiratory pressure [ Time Frame: From birth to 10 minutes of life ]
  • Heart rate [ Time Frame: Birth to 72 hours of life ]
  • Cardiac output [ Time Frame: From neonatal intensive care unit (NICU) admission through 72 hours of life ]
  • Mean arterial blood pressure [ Time Frame: From NICU admission through 72 hours of life ]
  • Use of cardiac inotropes [ Time Frame: From birth through discharge to home, up to 9 months of age ]
    Dopamine, dobutamine, epinephrine
  • Head Ultrasound [ Time Frame: Within 24 hours of life and at approximately 72 hours of life ]
  • MRI [ Time Frame: From birth through discharge to home, up to 9 months of age ]
    Presence of brain injury (e.g. intraventricular hemorrhage (IVH), (PVL)


Information By: Sharp HealthCare

Dates:
Date Received: October 30, 2015
Date Started: October 2015
Date Completion:
Last Updated: February 20, 2017
Last Verified: February 2017