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出境医 / 临床实验 / AEEG in Pre-term Infants (AEEG)

AEEG in Pre-term Infants (AEEG)

Study Description
Brief 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. 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 we can detect changes using aEEG early on, we will be able adjust treatment to make a baby better.

Condition or disease Intervention/treatment Phase
Preterm Infant Diagnostic Test: AEEG brain monitoring Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Amplitude Electroencephalography (aEEG) Monitoring in Preterm Infants: a Feasibility Study on a Neonatal Unit aEEG in Preterm Infants
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : October 30, 2020
Arms and Interventions
Arm Intervention/treatment
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, 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.

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.


Outcome Measures
Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   26 Weeks to 30 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
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Contact: Anthony Hart 07866931088 Anthony.Hart@sch.nhs.uk

Locations
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United Kingdom
Jessop Wing Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2SF
Contact: Anthony Hart    07866931088      
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Tracking Information
First Submitted Date  ICMJE April 2, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date July 5, 2019
Actual Study Start Date  ICMJE May 30, 2018
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AEEG in Pre-term Infants
Official Title  ICMJE Amplitude Electroencephalography (aEEG) Monitoring in Preterm Infants: a Feasibility Study on a Neonatal Unit aEEG in Preterm Infants
Brief 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. 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 we can detect changes using aEEG early on, we will be able adjust treatment to make a baby better.
Detailed Description

At the request of our funder (The Children's Hospital Charity), we 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 we 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. We 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 we do not want them making treatment decisions based on a test result they do not understand. However, we 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, 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.

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).

We 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

We 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. We will also ask the families for their permission to contact them in the future in the event that we obtain funding for a follow-on study, such as to examine their child's development in more detail in the future.

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

We 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Preterm Infant
Intervention  ICMJE 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.

Study Arms  ICMJE 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, 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.

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).

Intervention: Diagnostic Test: AEEG brain monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 2, 2019)
22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 26 Weeks to 30 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anthony Hart 07866931088 Anthony.Hart@sch.nhs.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04008498
Other Study ID Numbers  ICMJE STH19716
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sheffield Teaching Hospitals NHS Foundation Trust
Study Sponsor  ICMJE Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sheffield Teaching Hospitals NHS Foundation Trust
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP