HIE Connect

Parent Information Leaflet — Unexposed Cohort

1. Introduction

You have been given this leaflet because we are conducting a study to better understand the effects of a condition called hypoxic-ischaemic encephalopathy (HIE) caused by a lack of oxygen around birth, on early brain development. We will compare the early brain development of babies who had HIE to that of healthy babies who did not have any birth complications.

We invite you and your baby to take part in this study to help us with valuable information on brain development in healthy babies and contribute to understanding the early brain development in babies who had treatment for HIE. This leaflet will explain what the “HIE-CONNECT” study is about and what will happen if you decide to take part in the study.

2. What is the purpose of the study?

We would like to better understand how the functioning of the brain develops in the first year of life after receiving cooling therapy for HIE in comparison to babies who did not have HIE. We will also aim to understand how the early development and functioning of the brain are related to later intellectual development and factors around the birth or newborn period. The information we gather from this study will help us to improve the outcomes of babies who have had HIE.

3. Can my baby take part in the study?

Your baby can take part in the “HIE-CONNECT” study if they had a normal, healthy birth with no complications. Please note that participation in this study is completely voluntary and even if you decide to take part now, you can withdraw from the study at any later time.

4. What happens if I choose to take part?

If you are the parent or legal guardian of the baby, please read the following information carefully.

• If you will be willing to participate in the study, but have additional questions, please contact us using the email or telephone number below.

Tel: 07484511264
Email: hieconnect-study@bristol.ac.uk

• If you do not have additional questions and will be willing to participate in the study, please complete and sign the consent form, either online or return the completed paper version using the prepaid envelope. The consent form includes your contact information so that the research team can get in touch with you.
• If you are not willing to participate in the study, we would appreciate if you could email us the reason and offer feedback to improve the study (optional).

After we have received your contact details via the consent form, we will contact you to arrange the study visits. When you visit us, we will reconfirm the consent and provide you the copy of the consent form.

We will invite you and your baby to two study visits to the Cardiff University Centre for Human Developmental Science, located at 70 Park Pl, Cardiff CF10 3AT when your baby is around 3 and 6 months of age. We will pay for your travel, parking and provide food during your visit. When you and your baby come to the study visit, we will further explain the study and collect some information about your baby’s health and development, make you and your baby feel comfortable. We will then measure brain activity using EEG (measures the electrical signals in the brain using sensors placed on the scalp), and brain activation signal using fNIRS (uses light to measure changes in blood flow in the brain).

Both methods are safe and painless and will take about 3 hours to complete both measurements. We will video your baby during the recordings. These videos are important for quality control
purposes, for instance to ensure the sensors are in the correct position and to monitor your baby’s engagement throughout the session. We will ask
whether we can use photos and videos of your baby during the sessions for educational purposes and it is your decision whether you would allow that. You will be able to take a break, settle the baby for sleep and feed them at any point during the study visit.

We will perform EEG recording when your baby is awake and asleep. During EEG recording when awake, your baby will be sitting on your lap or in a highchair in front of a computer screen. To assess how your baby is learning about the environment, your baby will be shown some pictures and listen to sounds. We will use pictures and sounds familiar to babies, ensuring they feel comfortable.

We will use different measures to check whether your baby is awake or asleep. We will place a small belt around the baby’s chest without causing any discomfort to the baby to measure respiration. We may also put a few sticky electrodes on the baby’s chest to measure the heart rate. We may also put a few electrodes on the side of the eyes or on the chin to measure muscle activity. These measures help us understand your baby's sleep patterns and brain activity without causing any discomfort.

During the 3 months visit, we will also record a short 5 to 10 minute video of your baby lying on their back to observe their movements. These videos will be securely stored, only accessible to staff involved in the study, and kept until your baby is 25 years old. An optional visit will happen at 9 months of age.

During 3 and 6 months visits, we will ask you to fill out short questionnaires about your baby’s development and behaviour. These questionnaires are widely used by health professionals and researchers to help find out about your baby’s development. We will also ask you to fill out a questionnaire about your baby’s sleep habits. We will also collect information about your emotional well-being and any stress you may be experiencing concerning your childbirth experience. The questionnaires will be completed during the study visits either online or using a paper form. Additionally, you will be invited to fill out a questionnaire about your baby’s development when your baby is two years of age. This questionnaire will be sent to you electronically to complete online.

For a few babies, we will invite you for a brain MRI scan at 3 and 6 months of age. Brain scan will provide pictures of brain regions that will help us to match the signals we obtain from the fNIRS/EEG to the regions in the brain. Brain MRI scan will happen at Cardiff University Brain Research Imaging Centre (CUBRIC), Maindy Road, Cardiff, Wales, UK, CF24 4HQ, to do the MRI brain scan.

You will receive an Amazon voucher of £20 at the 6 months visit as a thank you for participation in the study. We will offer to send a plain English summary of the study results to parents or guardians who would like to receive them.

5. Are there any advantages to taking part?

This study will help us better understand the effects of oxygen deprivation around birth after treatment with cooling therapy on development of brain function. This could help us improve and develop strategies to promote the healthy development of the babies who sustained HIE at birth. There is no direct benefit for participating in the study.

6. Are there any risks involved with participating in the study?

There are no risks associated with the study that could have an impact on your baby’s health and wellbeing.

For EEG and fNIRS recordings, a soft cap will be placed on your baby’s head. Your baby might experience slight discomfort when placing EEG caps on their head and there is a slight chance of minor skin irritation. If your baby is invited for brain MRI scan, the scan is safe and does not impact your baby. There is no radiation involved. To prevent exposure to noise associated with some scan sequences, your baby will wear a headphone during the scan.

The travelling and spending time at our research site can be tiring for you. We will work with you to ensure that visits are not burdensome by scheduling breaks in between sessions, and making sure you have enough rest. Our goal is to make the experience as easy and comfortable as possible for you.

We understand that talking about the birth can be tough for you. Our research team is here to help and we know how to support you. If you are really struggling or if you tell us you are feeling down or have other mental health worries, we will ask your permission and then contact your GP, health visitor, perinatal team including perinatal mental health team to organise some extra support.

7. Can I change my mind?

You and your baby have the right to withdraw from the study at any time point without giving any reason. You can do that by contacting the research team (contact details are at the end of the document).

8. Who has reviewed this study?

This study has been reviewed and approved by the UK’s National Research Ethics Committees (REC) [North West - Preston Research Ethics Committee].

9. Who is organising the study?

The study is sponsored by the University of Bristol and run by the research team who are based at the University of Bristol and Cardiff University. This study is part of a PhD run by Sara Rapuc and Chief Investigator Dr Ela Chakkarapani.

10. How will my personal information be handled?

The University of Bristol is the ‘data controller’ with respect to the use of your personal information collected for the “HIE-CONNECT” study. The personal information that we process will include your name and your baby’s name, your email address, your phone number and home address. We will use your personal information to get in touch with you to invite you to the study visits. Wherever possible we will use a code number instead of your personal information and will keep the number of people who have access to your information to an absolute minimum. The only people allowed to look at the information will be the researchers who are running the study, the staff at the study coordinating centre, and the regulatory authorities who check that the study is being carried out correctly. We will remove all the personal information, when we analyse the information about you and your baby. We will keep all information about you safe and secure. Some of your information will be used to check that the research is being done properly.

Once we have finished the study, we will keep some of the information so we can check the results. We will write our reports in a way that no- one can work out that you and your baby took part in the study.

What are your choices about how your information is used?

You and your baby can stop being part of the study at any time, without giving a reason, but we will ask you whether we can keep and analyse the research information about your baby that we already have. We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you and your baby.

Where can you find out more about how your information is used?

You can find out more about how we use your information:

• Via the University of Bristol website
• by writing to “HIE-CONNECT” study, Level D Neonatal Neuroscience, St Michael’s Hospital, Southwell Street, Bristol. BS2 8EG.
• by sending an email to the ‘University Data Protection Officer’: data-protection@bristol.ac.uk

11. What if something goes wrong?

Complaints procedure

If you are concerned about this study, or the way it has been carried out, please talk to the research team via hieconnect-study@bristol.ac.uk.

If you wish to make a complaint please contact the University of Bristol’s Research Governance Team: research-governance@bristol.ac.uk.

Indemnity

This study will be sponsored by the University of Bristol. The University has Clinical Trials Liability Insurance to cover the liability of the University to research participants. In the event that something goes wrong and a participant is harmed during the research study there are no special compensation arrangements. If a participant is harmed and this is due to someone's negligence then they may have grounds for a legal action for compensation against University of Bristol or one of the other parties to the research, but they may have to pay their own legal costs.

12. Who can I contact for more information?

Any study-related questions can be posed to the research team. Contacts are provided below.

HIE-Connect Research Team
Neonatal Neuroscience
Level D, St Michael’s Hospital
Southwell Street, Bristol.
BS2 8EG

Tel: 07484511264
Email: hieconnect-study@bristol.ac.uk