Participant information
Study title: Prospective study to identify risk factors predictive of death, requiring Extracorporeal Membrane Oxygenation (ECMO) or cardiac disease in neonates referred to UK neonatal and paediatric transport services with respiratory failure.
Chief Investigator: Jonathan Lillie
Summary: please read this first
We know this may reach you at a very difficult time. You do not need to read it now, or do anything at all. Decisions resulting from the information below can be made at any time in the coming weeks.
Your baby was moved between hospitals by a specialist transport team because of serious breathing problems. We would like to include information about babies like yours in a national research database.
Your baby's care does not change. We only use information that is already recorded as part of normal care. There are no extra tests, visits or questionnaires.
You do not need to do anything. Your baby's information will be included unless you tell us you do not want it to be.
You can say no (opt out) at any time, without giving a reason, and it will not affect your baby's care. This study is non-commercial and for NHS benefit only. Information is never shared with companies.
Do not want your baby's information included? Opt out at any time.
You do not need to give a reason, and it will not affect your baby's care in any way. You can:
- fill in the short opt-out form (or scan the QR code on the leaflet or poster)
- tell any member of the team caring for your baby
- email the study team: contact@neovisor.uk
- register a National Data Opt-out at www.nhs.uk/your-nhs-data-matters
Research background and goal
Newborns with breathing problems often need to move to another hospital for more specialist care in a neonatal intensive care unit (NICU). A small number of these babies do not respond to this care and may need a further transfer so they can receive a higher level of care, including ECMO. ECMO stands for ExtraCorporeal (out of the body) Membrane Oxygenation. Blood is taken out of the body, oxygen is added by a machine, and the blood is returned to the patient. Results from an early study across London suggest a significant number of babies (27 out of 149) require a second transfer between intensive care units or become more unwell.
Our study looks at babies very early in their journey, when they are referred from the local hospital to the specialist neonatal transport team. By looking at key numbers and information on their treatment, we aim to identify risk factors that suggest which babies are the most unwell, need ECMO or have an undiagnosed heart condition.
If we can find these risk factors, in future they could be used to decide at an earlier stage where these babies are best cared for (either an ECMO centre or a neonatal intensive care unit). We aim to make sure the right babies go to the right centre, improving outcomes and avoiding additional moves between hospitals.
What taking part involves
Babies receive their normal care and all data used in the study is already routinely collected. After the baby is transported, data about their clinical condition and treatment is uploaded into a secure online database. The baby's NHS number is used to link this data to large databases covering neonatal and paediatric intensive care across the UK: the NHS Spine, PICANet (which audits paediatric intensive care) and BadgerNet (which records care delivered by NICUs). This is important so that we can understand what happened to every baby.
Because this information is already collected as part of your baby's care, we do not ask parents for separate consent. We did not want to add to an overwhelming and stressful time. You can still say no at any time.
Why would your child's information be helpful?
We are looking at how newborns with respiratory illness become unwell, and what their care journey is. If your child needed to be moved between hospitals because of respiratory illness around the time of birth, looking at routinely recorded care information may help other babies in the future.
Do you have to take part?
No. It is up to you to decide if your baby's data will be used. You can ask for your child's data to be deleted at any time and without giving a reason. Deciding not to take part will not affect the healthcare your child receives, or your legal rights.
Possible benefits
There are no direct benefits to you, but the results of this study might help to improve the healthcare of babies in the future.
How will we use information about you?
We will use information from your baby's medical records for this research project. This includes your baby's NHS number and details of their condition, treatment and recovery. We do not store your baby's name, address or date of birth in the study database.
People will use this information to do the research, or to check records to make sure the research is being done properly. Only people who need to know who you are can see your details. Your data will have a code number instead.
Guy's and St Thomas' NHS Foundation Trust is responsible for looking after your baby's information and is the data controller for this study. We use it because the research is a task in the public interest. Only the NHS number is stored with your baby's medical details, and the study team works with a code number instead. Information is kept on secure NHS systems in the UK and never shared with companies.
International transfers: your data will not be shared outside the UK.
How long we keep it: study data will be securely archived for 25 years and then destroyed.
Your choices about how your information is used
You have the right to opt out of your data being used (see Your NHS Data Matters). You can stop being part of the study at any time, without giving a reason, and ask us to remove your data from the REDCap database for the purposes of the study.
Where can you find out more about how your information is used?
- on this website, or at the QR code on the leaflet and poster
- by asking the study team (contact details below)
- at www.hra.nhs.uk/information-about-patients
- at the Guy's and St Thomas' data and research page
- by contacting the Guy's and St Thomas' Data Protection Officer: gstt.dpo@nhs.net
Concerns and complaints
If you have a concern about any part of this study, please ask to speak to the researchers, who will do their best to answer your questions. If you remain unhappy and want to complain formally, you can contact the Guy's and St Thomas' Patient Advice and Liaison Service (PALS): phone 020 7188 8801, email gstt.pals-gstt@nhs.net. The PALS team are in the main entrance on the ground floor at St Thomas' Hospital and on the ground floor at Guy's Hospital in the Tower Wing.
Who is organising and reviewing the study?
The study is organised by the Evelina Paediatric Intensive Care department, sponsored by Guy's and St Thomas' NHS Foundation Trust, and funded by the Evelina Paediatric Intensive Care department. It has been reviewed by a Research Ethics Committee, the Confidentiality Advisory Group, GSTT Research & Development, and parents with experience of neonatal transfer.
Contact the study team
Dr James Diviney
Patient and Family contact lead for NeoVISOR
contact@neovisor.uk
Dr Jon Lillie
Chief Investigator
jonathan.lillie1@nhs.net
Do not want your baby's information included? Opt out at any time.
You do not need to give a reason, and it will not affect your baby's care in any way. You can:
- fill in the short opt-out form (or scan the QR code on the leaflet or poster)
- tell any member of the team caring for your baby
- email the study team: contact@neovisor.uk
- register a National Data Opt-out at www.nhs.uk/your-nhs-data-matters