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Follow Up

More about the follow up study

Below you will find information about the follow up when children will be followed up for 5 years. This is in a question and answer format.

What is the purpose of the study?

Children with Down's syndrome may have more health problems than other children. Not all of these problems are apparent at birth. Medical research has helped us to understand these better, but there are still many unanswered questions. By collecting as much information as we can from babies and children with Down's syndrome, we hope to find out more about their health. This will increase our understanding of Down's syndrome, enabling us to improve the healthcare these children receive.

Who is doing the study?

The study is being led by scientists at the University of York . In addition to the researchers there, doctors and nurses involved in the care of babies and children with Down's syndrome are taking part.

How are children chosen to enter the study?

We are interested in all babies and children with Down's syndrome born after 1st May 2006 in the UK. Some of the children may have already taken part in the study when they were newly born.

What does the study involve?

We would like to follow each child up over 5 years collecting information about their health and taking samples.

How will the information be collected?

This will be collected in two ways:
  • We will send questionnaires to the families when their child enters follow up and then on a regular basis.
  • We will ask for permission to access each child's hospital and community medical records. We will also ask mothers for permission to access the maternity records relating to the pregnancy. A member of our research team will then record relevant information from these medical records.

What sort of samples will be collected?

  • An extra amount of blood when each child is having a blood test done for another reason at approximately yearly intervals;
  • A mouth swab from each child once when they join the follow up;
  • A mouth swab from each biological parent, if this is possible, once when their child joins follow up.

How will the blood samples be collected?

Most children with Down's syndrome have routine tests done to monitor their thyroid function. The frequency of these varies in different areas, but in many places these are done yearly.

When each child is due to have a blood test we will send each family a small tube to take to the clinic with them. The person taking the test just needs to collect an extra amount of blood into the tube. We will also send the families an envelope so that the sample can be posted straight on to the laboratory.

How will the mouth swabs be taken?

These are like cotton buds. They just need to be brushed around the inside of the mouth. This should not hurt. We would like to take mouth swabs from each child and both biological parents, if this is possible, when they join the follow up.

We will send the packs directly to each family, and will discuss with them whether they would prefer to take the swabs themselves, or whether they would prefer to take them to clinic to have them done there.

Why do you need to access each child's medical records?

We need to know about any problems that each child may have had, or may still have. We will then be able to see if these are associated with any changes that we may have noticed in the tests.

Will the information be kept confidential?

All information provided is totally confidential and kept in accordance with the Data Protection Act. Information is processed by a restricted number of staff working on the study, all of whom have been trained in confidentiality procedures. The information will then be stored and managed by the University of York .

Each child in the study will be given a code number. This will be used to anonymously link information about their health with their samples. This means no one will be able to trace or identify any child from the data. Each child's samples and information will only be used for research into the health of children with Down's syndrome and will not be passed on to anyone else.

Why do you need blood samples?

Children with Down's syndrome are at increased risk of a number of disorders affecting blood cells. These range from minor changes in the size or number of blood cells to more serious disorders like leukaemia. At present we do not know much about what the minor changes mean, or about the factors influencing the development of more serious problems. By following the blood counts of a group of children with Down's syndrome over 5 years we hope to find out more. The samples will be used for research purposes only, and will be stored in the Biology Department at the University of York .

What will you do if you find a serious change a child's blood sample taken for the study?

The results of the various tests we do will not be fed back routinely to the families or to the child's doctor. However, it is possible that the blood test might be abnormal even if a child has no symptoms. If we do see a serious abnormality in the full blood count result that needs further follow up we will contact the child's doctor so that the child can receive the best care possible.

Why do you need mouth swabs?

Advances are being made all the time which enable us to look for differences in an individual's susceptibility to disease. Most of these tests involve looking at an individual's DNA. Mouth swabs are a painless way of obtaining DNA. We will then store the DNA in the Department of Biology at the University of York so that we can analyse it in the future and can compare differences in particular genes with the patterns of health experienced by each child.

Why should families take part?

We hope that the information collected from the children in the study will lead to a greater understanding of the health of children with Down's syndrome in order to improve their care. In order for our results to be meaningful, it is very important that as many children take part in the study as possible.

What happens if families initially join the study but then change their minds?

Families can choose to withdraw their baby from the study at anytime without giving a reason. All they need to do is to contact us and tell us their decision. If they do this then any information they have supplied and any samples from their baby will be destroyed.

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