AEEG in Pre-term Infants (AEEG)

August 3, 2023 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

Amplitude Electroencephalography (aEEG) Monitoring in Preterm Infants: a Feasibility Study on a Neonatal Unit aEEG in Preterm Infants

Amplitude integrated encephalography (aEEG) is a monitor that measures brain activity by attaching leads to a baby's head, and is used routinely in term babies who have brain injury because of a difficult birth. There is little information on how useful aEEG is in premature babies, and most studies only look at small numbers of babies. However, these studies suggest that the aEEG is different in premature babies with brain injury, infections / meningitis, and in those receiving certain drugs. It is also affected by changes in blood pressure and blood acid levels. It is theoretically possible that, if the investigators can detect changes using aEEG early on, the investigators will be able adjust treatment to make a baby better.

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

At the request of our funder (The Children's Hospital Charity),the investigators have been asked to split the research methodology into two phases to secure the full amount of our funding. The differences between the two phases relates to the length of aEEG recording and whether the babies get the follow-up at discharge from the neonatal unit. The reason for developing two phases is that the funder wishes us to prove the concept that the investigators can recruit premature babies to have aEEG using one machine before they pay for a second monitor to allow for the full study to run. The inclusion and exclusion criteria will be the same for both phases of the study.

PHASE ONE:

Methodology:

The baby of any family who consent to be involved in the study will have their head cleaned using a sterile solution. The 5 sticky EEG leads placed on the head and connected to the monitor. The investigators will not use needle electrodes because of the risk of infection and scarring. The screen of the monitor will be covered with a black piece of card so it is not visible to staff or families. This is because the staff do not know what is a normal or abnormal aEEG in a premature baby, and doctors do not want them making treatment decisions based on a test result they do not understand. However, the investigators will ask the nurses to check the screen at the time of usual observations to check that the monitor is still recording and the leads have not fallen off. This can be done by looking at the "impedance" on the screen, as would happen for babies born at term who have aEEG. Nursing staff will also be asked to review the skin regularly at the time of usual cares to make sure it remains healthy.

The aEEG will be recorded continuously for one week, and will then stop. No further follow-up or intervention is planned.

The funders require us to show proof of concept in 6 premature babies before releasing the remainder of our money for additional monitors, nursing time and equipment.

Staff will review the aEEG monitor at the time of usual observations to ensure that the machine is recording, the impedence is within normal levels, a trace is recorded, the EEG leads remain attached, and the skin condition is good.

PHASE TWO:

Babies whose families consent to involvement will have their head cleaned, EEG leads attached, the monitor set up, and observations as described in phase one. The main difference in the two phases is the timing of recording.

In phase two, babies will be recorded continuously for the entire duration of their time on the intensive care unit.

Once the child is receiving high dependency or special care, the investigators will record aEEG for 4 hours once a week until the baby is discharged home. If a participant is moved back to intensive care, the aEEG will be started again if the aEEG monitor is not being used on another baby.

Before being discharged home, the babies in phase two will have additional follow-up. They will receive magnetic resonance imaging (MRI) of the brain on either a 1.5T or dedicated 3T (Firefly) scanner at the University of Sheffield. They will also have a standardised examination of their neurological system performed by a physiotherapist (The Hammersmith Neonatal Neurological Examination).

The investigators will collect clinical details retrospectively from the observation charts and medical notes, including:

  • The gestation age of the baby
  • How long they received ventilation or other forms of respiratory support for
  • How long they needed oxygen for and, and maximum oxygen requirement each day
  • How many infections (sepsis) they had and which organisms were found
  • Whether they had a heart defect called a patent ductus arteriosus and whether treatment was needed for this
  • What the results of their ultrasound scans of the brain were, which are performed routinely in premature babies
  • Whether they had a gut problem called necrotising enterocolitis and whether surgery was needed
  • Whether they developed post-haemorrhagic ventricular dilation, and need for intervention
  • Survival to discharge

The investigators will ask the families for consent to examine any future medical notes / clinic letters to see what the baby's development was like later in life. The investigators will also ask the families for their permission to contact them in the future in the event that the investigators obtain funding for a follow-on study, such as to examine their child's development in more detail in the future.

The investigators will ask parents to complete a short questionnaire about their experience of the monitoring.

The investigators will ask the neonatal nurses to complete a short questionnaire about their experience of the monitoring and whether they have ideas for improving the process, or any training they would like to have.

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.
Interventional

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.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2SF
        • Jessop Wing

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

6 months to 6 months (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Preterm infants between 26+0 and 30+0 weeks gestational age
  • Requiring intensive care following birth
  • Live in Sheffield catchment area
  • English speaking
  • No skin viability issues on the head
  • Study aEEG monitor available for use
  • No known genetic, congenital structural brain abnormality, congenital infection, metabolic condition or other disorder likely to impact on neurological function independent of preterm birth

Exclusion Criteria:

  • Under 26+0 gestational age
  • Known genetic, congenital structural brain abnormality, congenital infection, metabolic condition or other disorder likely to impact on neurological function independent of preterm birth
  • Non-English speakers
  • Non consent

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: AEEG monitoring

Babies whose families consent to involvement will have their head cleaned, EEG leads attached, the monitor set up, and observations.

Babies will be recorded continuously for the entire duration of their time on the intensive care unit.

Once the child is receiving high dependency or special care, the investigators will record aEEG for 4 hours once a week until the baby is discharged home. If a participant is moved back to intensive care, the aEEG will be started again if the aEEG monitor is not being used on another baby.

Before being discharged home, the babies will have additional follow-up. They will receive magnetic resonance imaging (MRI) of the brain on a 1.5T scanner at the University of Sheffield. They will also have a standardised examination of their neurological system performed by a physiotherapist (The Hammersmith Neonatal Neurological Examination).
Diagnostic test: AEEG brain monitoring

Babies will be recorded continuously for the entire duration of their time on the intensive care unit.

Once the child is receiving high dependency or special care, we will record aEEG for 4 hours once a week until the baby is discharged home. If a participant is moved back to intensive care, the aEEG will be started again if the aEEG monitor is not being used on another baby.

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
Recruitment Rate
Time Frame: Upto 24 months after recruitment
This is a feasibility study to inform the design of a larger multi-centre study. Rate of recruitment will determine how many centre's required for a larger study. Amount of time required to reach recruitment targets will inform average recruitment rate.
Upto 24 months after recruitment
Optimal Timing For AEEG Recording
Time Frame: Upto 24 months after recruitment
This is a feasibility study to inform the design of a larger multi-centre study. The results of full AEEG recordings will demonstrate important time points to be recorded for larger study. Time points of abnormal brain activity will be measured and recorded.
Upto 24 months after recruitment

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.
Sheffield Teaching Hospitals NHS Foundation Trust

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 (Actual)

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.
May 30, 2018

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.
April 30, 2022

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.
April 30, 2022

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).
April 2, 2019

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.
July 2, 2019

First Posted (Actual)

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.
July 5, 2019

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.
August 7, 2023

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.
August 3, 2023

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.
August 1, 2023

More Information

Terms related to this study

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.
  • STH19716

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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