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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sharp HealthCare

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Gerber Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 13, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Neu-Prem

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