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Completed

NCT Number: NCT02605733

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

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.

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Key information

Conditions

Neurologic Manifestations Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Female Urogenital Diseases and Pregnancy Complications Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Nervous System Diseases Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Signs and Symptoms, Respiratory Urogenital Diseases Vascular Diseases

Age range

Up to 72 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EEG

Device

amplitude integrated electroencephalography

Other names: amplitude integrated electroencephalography

NIRS

Device

regional tissue oximetry

Other names: Near-infrared spectroscopy

Primary outcomes

  1. EEG

    Time frame: Birth to 72 hours of life

    amplitude integrated EEG to measure brain activity

  2. NIRS

    Time frame: Birth to 72 hours of life

    Cerebral tissue oxygen saturation (StO2), Near-infrared spectroscopy to measure brain perfusion

Secondary outcomes

  1. Apgar scores

    Time frame: 1, 5 and 10 minutes of life if applicable

    1 and 5 minute Apgar scores

  2. Cord gases

    Time frame: Upon delivery

    Arterial or venous pH (acid/base), base deficit

  3. Resuscitation intervention

    Time frame: From birth to 10 minutes of life

    Fraction of inspired oxygen (FiO2), cpap, positive pressure ventilation (PPV), intubations.

  4. Maximum FiO2

    Time frame: From birth to 10 minutes of life

    Maximum FiO2 during resuscitation at birth

  5. Maximum peak inspiratory pressure

    Time frame: From birth to 10 minutes of life

    Peak inspiratory pressure of respiratory support

  6. Heart rate

    Time frame: Birth to 72 hours of life

  7. 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).

  8. Cardiac output

    Time frame: From neonatal intensive care unit (NICU) admission through 72 hours of life

  9. Mean arterial blood pressure

    Time frame: From NICU admission through 72 hours of life

  10. Use of cardiac inotropes

    Time frame: From birth through discharge to home, up to 9 months of age

    Dopamine, dobutamine, epinephrine

  11. Head Ultrasound

    Time frame: Within 24 hours of life and at approximately 72 hours of life

    Cranial ultrasonography

  12. 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)

  13. Neurodevelopmental impairment at 2 year follow up

    Time frame: 18 to 30 months corrected gestational age

    Neurodevelopmental assessment at 2 year corrected gestational age

Sponsors and collaborators

Lead sponsor

Sharp HealthCare

Other

Collaborators

  • The Gerber Foundation

Registry information

Acronym: Neu-Prem

Important dates

Study start
2015
Primary completion
2016
Study completion
2021
First posted
Nov 16, 2015
Registry last updated
Dec 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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