The BASELINE study
Information for Parents
What is the Baseline Study?
You and your baby have been followed very closely from early on in your pregnancy. The doctors and nurses of the SCOPE study will be following your baby’s growth in the womb until just after they are born. We know that many things which may effect your baby’s growth in the womb may also effect their growth and health in early childhood.
We hope to continue to meet you and your child after the birth to look at how they grow and develop. The Baseline study will be focused on your baby’s growth, health and development over the next two years and beyond.
We will collect information about common childhood illnesses like asthma, eczema and food allergy. We will look at each child’s growth over the first two years of life and compare this to the growth patterns before birth when they were in your womb. Using simple questionnaires and growth measurements we will be able to gain very important information which may help us to find out why some children develop common childhood illnesses and some don’t.
If your baby has poor growth (growth restriction) during your pregnancy they will be followed even more closely for their growth after birth. Many babies “catch up” in weight and length quickly after birth, but some don’t. Those babies who catch up too quickly may be at risk of obesity and diabetes in later life. We need more information before we can give parents accurate advice about this important issue. We will also be looking more closely at these children at two years of age, and will carry out detailed assessments of their development and their sugar handling.
What will the study involve?
If you are happy for the Baseline research team to follow your baby after they are born, a sample of blood will be taken from the baby’s umbilical cord and stored with your blood samples in the SCOPE biobank (this does not hurt as there is no sensation in the cord). Your baby’s weight, length and head circumference will be measured as part of the SCOPE study. Your baby’s progress after birth will be recorded. If your baby needs any extra medical care the details of this care will be collected from your baby’s medical notes. This information will be anonymous, and will identified only using a study number, not your baby’s name or address.
There will be routine appointments at 2, 6, 12 and 24 months when you will be contacted and an appointment will be made for a follow up assessment at a time convenient for you and your family. This will happen in the Children’s Day Unit of the Cork University Hospital. You will be asked to fill in straightforward questionnaires asking you about your child’s health and diet. One of our research nurses will measure your baby’s height, weight, head size and body fat. At your first visit you will also be asked to bring a stool sample in a special container given to you at birth. At each visit your baby will be checked for eczema and will have skin tests for common allergies at 12 and 24 months. You may also be asked to consent to your child giving a single blood test at 2 years of age which will measure their Vitamin D levels and their sugar handling. Babies who show problems related to the study topics such as eczema, diabetes or have problems with development will be monitored more closely by the study team. If your baby has unrelated illnesses such as colds and chest infections, you should see your family doctor first.
If your baby has poor growth (growth restriction) before they are born, we will also arrange a more detailed assessment of their development. This will be carried out by an educational psychologist at 2 years of age.
What are my options?
Being part of the Baseline study is completely voluntary. You can continue to be part of the SCOPE study during your pregnancy even if you choose not to be part of the Baseline study. You or your child can withdraw from the Baseline study at any stage. Not being part of the Baseline study will not affect any part of the medical care of you or your baby.
The Baseline study will be managed by the staff of the University College Cork’s Departments of Paediatrics and Child Health and Nutrition. We will publish our results in international medical journals. Once a year we will organize a meeting to tell families about how the study is progressing. With your permission we will keep your family doctor up to date with any relevant health issues that arise for you and your baby during the study.
Where can I get more information?
If you have any questions regarding the Baseline study, please contact the research coordinators
Dr Deirdre Murray or Prof Jonathan Hourihane
Dept of Paediatrics and Child Health
Clinical Investigations Unit,
Cork University Hospital
Tel: +353 21 4901271
Fax: +353 21 434 5217