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The BABY project
What is the BABY (Born and Bred in Yorkshire) project?
BABY is a long term study which aims to track a large group of babies born in Yorkshire, and their parents, from pregnancy onwards. A wide range of information about the health and wellbeing of babies and their parents will be collected when they enter the study, and at intervals in the future.
What is the purpose of the study?
The first purpose of BABY is to find out as much as we can about the health and wellbeing of babies and their parents during pregnancy, labour and after birth. The second purpose is to help the NHS and other health researchers do important studies on the health and wellbeing of children and adults in future.
Who is doing the study?
The study is being done by researchers at Hull York Medical School and the University of York, and doctors and midwives involved in the care of babies and their parents in the local NHS Trust.
Why was I chosen?
Around 3,500 babies are born in York each year. The mothers of all babies due to be born in York during the next 12 months are being invited to take part.
Can fathers take part?
Mothers who join the study may also choose to invite their partners to take part.
Why should I help?
Information collected about you and your baby could lead to a greater understanding of the health of babies, children and mothers and fathers now and in the future.
What does the study involve?
The study has several parts but you do not have to be involved in all of them. If there is any you would prefer not to take part in, you can indicate this on the consent form and your wishes will be respected. With your consent, we will let your GP know that you are taking part in BABY.
The study includes:
• Looking at your medical records, including maternity, hospital and GP records, and your baby's neonatal and paediatric notes.
• Sending you short questionnaires about your wellbeing every 3 months during pregnancy and in the first year after your baby's birth.
• Collecting a cord blood sample after your baby's birth.
• Giving permission to be contacted again about other parts of the study.
Why do you need to look at medical records?
We need accurate information about the health of you and your baby.
What is cord blood?
Cord blood is the blood that remains in the placenta and umbilical cord. After birth, the umbilical cord is usually clamped. It is normally thrown away as clinical waste with the placenta.
Why do you need a cord blood sample?
There are many influences on health we know very little about at present, and samples will be stored for use in future analyses. We are collecting cord blood samples for research purposes only. We are NOT collecting stem cells for the treatment of disease.
How will you collect the cord blood sample?
After your baby is born, the umbilical cord will be clamped and cut. The cord will be passed with the placenta to a trained healthcare professional, who will collect the blood using a special needle and a sterile collection tube. There is no risk to you or your baby and it will not interfere with your baby's birth.
What happens to my cord blood sample?
It will be frozen and stored for use in future research projects.
Will the information I provide be kept confidential?
Yes. All information you provide is confidential and kept in accordance with the Data Protection Act. No one outside the research team will be able to trace or identify you or your child. The samples and information collected will be used for research purposes only.
Do I have to take part?
It is up to you to decide whether or not you would like to take part. Mothers may take part even if their partners do not. If you take part, you are free to withdraw at any time. Your decision will not affect the standard of care you or your baby receives or the relationship with your midwives or doctors.
What should I do now?
If you wish to take part, please read and sign the consent form and complete the Family Details sheet. Two consent forms are provided, one for mothers and one for fathers.
The bottom copy of the consent form is for you to keep and the top copies should be returned to us with the Family Details form in the prepaid envelope attached - it does not need a stamp. If you prefer, you may join the study by going to the study website and completing a consent form online.
What if I change my mind?
You can join or withdraw from the study at any time. If you wish to do either of these, please contact us using the contact details below.
Standard NHS indemnity arrangements apply to this research.
For more information please call the freephone number, visit our website or email the address below:
Freephone: 0800 3280655
Website: www.bornbredyorks.org or EMU@york.nhs.uk
Research midwives telephone number: 01904 721982
Address: BABY, HYMS EMU, Learning and Research Centre,York Hospital, Wiggington Road , York, YO31 8HE.