Condition or disease | Intervention/treatment | Phase |
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Preterm Infant | Diagnostic Test: AEEG brain monitoring | Not Applicable |
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 |
Arm | Intervention/treatment |
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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. |
Ages Eligible for Study: | 26 Weeks to 30 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anthony Hart | 07866931088 | Anthony.Hart@sch.nhs.uk |
United Kingdom | |
Jessop Wing | Recruiting |
Sheffield, South Yorkshire, United Kingdom, S10 2SF | |
Contact: Anthony Hart 07866931088 |
Tracking Information | |||||
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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 |
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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:
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. |
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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 |
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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. |
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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
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 26 Weeks to 30 Weeks (Child) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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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 |