Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04008498 |
| Other study ID # |
STH19716 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 30, 2018 |
| Est. completion date |
April 30, 2022 |
Study information
| Verified date |
August 2023 |
| Source |
Sheffield Teaching Hospitals NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
