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

December 9, 2021 updated by: Anup Katheria, M.D., Sharp HealthCare
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • Sharp Mary Birch Hospital for Women and Newborns

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Premature infants delivered at 23 to 31 +6 weeks gestational age at Sharp MBHWN.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEG
Time Frame: Birth to 72 hours of life
amplitude integrated EEG to measure brain activity
Birth to 72 hours of life
NIRS
Time Frame: Birth to 72 hours of life
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
Time Frame: 1, 5 and 10 minutes of life if applicable
1 and 5 minute Apgar scores
1, 5 and 10 minutes of life if applicable
Cord gases
Time Frame: Upon delivery
Arterial or venous pH (acid/base), base deficit
Upon delivery
Resuscitation intervention
Time Frame: From birth to 10 minutes of life
Fraction of inspired oxygen (FiO2), cpap, positive pressure ventilation (PPV), intubations.
From birth to 10 minutes of life
Maximum FiO2
Time Frame: From birth to 10 minutes of life
Maximum FiO2 during resuscitation at birth
From birth to 10 minutes of life
Maximum peak inspiratory pressure
Time Frame: From birth to 10 minutes of life
Peak inspiratory pressure of respiratory support
From birth to 10 minutes of life
Heart rate
Time Frame: Birth to 72 hours of life
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).
Birth
Cardiac output
Time Frame: From neonatal intensive care unit (NICU) admission through 72 hours of life
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
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
From birth through discharge to home, up to 9 months of age
Head Ultrasound
Time Frame: Within 24 hours of life and at approximately 72 hours of life
Cranial ultrasonography
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)
From birth through discharge to home, up to 9 months of age
Neurodevelopmental impairment at 2 year follow up
Time Frame: 18 to 30 months corrected gestational age
Neurodevelopmental assessment at 2 year corrected gestational age
18 to 30 months corrected gestational age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sharp HealthCare

Collaborators

The Gerber Foundation

Investigators

  • Principal Investigator: Anup Katheria, MD, Sharp HealthCare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

May 13, 2021

Study Registration Dates

First Submitted

October 30, 2015

First Submitted That Met QC Criteria

November 12, 2015

First Posted (Estimate)

November 16, 2015

Study Record Updates

Last Update Posted (Actual)

December 13, 2021

Last Update Submitted That Met QC Criteria

December 9, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neu-Prem

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neurologic Manifestations

Clinical Trials on EEG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe