AEEG in Pre-term Infants

NCT ID: NCT04008498

Last Updated: 2023-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-30
• Study Completion Date: 2022-04-30

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 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.

Conditions

Preterm Infant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

AEEG brain monitoring

Intervention Type: DIAGNOSTIC_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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 26 Weeks
• Maximum Eligible Age: 30 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jessop Wing

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

STH19716

Identifier Type: -

Identifier Source: org_study_id