Preterm InfantAEEGNCT04008498
AEEG in Pre-term Infants
A study testing AEEG brain monitoring in people with Preterm Infant, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 26 to 30 weeks
- Conditions the study is for
- Preterm Infant
- What is being tested?
- AEEG brain monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 May 2018to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 30 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Preterm Infant
- Being tested
- AEEG brain monitoring
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEEG brain monitoringDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| AEEG monitoring | Experimental | 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). Receives: Diagnostic Test: AEEG brain monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
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.
Measured: Upto 24 months after recruitment
Optimal Timing For AEEG Recording
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.
Measured: Upto 24 months after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start30 May 2018
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008498
- Sponsor's protocol ID
- STH19716
- Acronym
- AEEG
- Status last verified
- Aug 2023
- First submitted
- 2 Apr 2019
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amplitude Electroencephalography (aEEG) Monitoring in Preterm Infants: a Feasibility Study on a Neonatal Unit aEEG in Preterm Infants
- ClinicalTrials.gov ID
- NCT04008498
- Acronym / sponsor ID
- AEEG / STH19716
- Conditions
- Preterm Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AEEG monitoring | Experimental | Diagnostic Test: AEEG brain monitoringBabies 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). |
Who may qualify
- Ages
- 26 to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AEEG brain monitoringBabies 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. | Diagnostic test | AEEG monitoring |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AEEG brain monitoring in people with Preterm Infant, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Upto 24 months after recruitment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.