The SOPHIE Study is a research study at University College Cork and Cork University Maternity Hospital/Cork University Hospital. Researchers at INFANT, UCC are looking for healthy children aged 5-11 years old to take part in this study.
- What is the Study?
‘SOPHIE’ is an acronym for ‘School-aged Outcomes Post Hypoxic Ischaemic Encephalopathy’. Some children are diagnosed with hypoxic ischaemic encephalopathy (HIE) after birth. These babies need extra help after delivery, due to issues with oxygen and blood flow to their brain. They are admitted to the neonatal unit and receive special treatment to help their brain to recover.
There is very little information on how children who have been diagnosed with HIE in the newborn period continue to develop after two years of age. We know that some children have difficulties at school, but we don’t know how to identify these children early so that we can intervene sooner and improve their long-term outcomes.
We are looking for healthy children to volunteer also to have a developmental assessment and if they wish, an MRI brain scan.
The project is supervised by supervisors from University College Cork, Cork University Hospital, and INFANT Research Centre.
- Who is it for?
Healthy children aged 5-11 years old who have no known developmental issues. Children are eligible if they were born after 36 weeks gestation and were not admitted to the neonatal unit within 12 hours of birth.
- What do I need to do?
The study has two parts – the first visit is for the developmental assessment. The second visit is optional, for an MRI brain scan. Both visits take place at Cork University Hospital.
- Developmental assessment: This takes about 1.5 hours and involves a brief IQ test (using pictures and puzzles) and playing games on an iPad.
- MRI Brain: The scan itself takes about 20 minutes but you would be in CUH for about 1 hour in total.
- Why is this study being done?
By conducting these tests, we hope to gain information on how to identify issues earlier and improve long-term outcome in children diagnosed with HIE in the newborn period.
- What are the benefits and risks of participating in this study?
By participating in this study, you are contributing to important research on childhood development and brain injury. The aim is that the results from this study will help to improve the outcomes for children and gain specific interventions sooner to maximise their developmental growth over early childhood.
It may be of interest to you or your child to have a developmental check, an IQ test, and/or an MRI brain scan. If there are findings from either visit that need to be discussed or addressed, a member of the consultant team will meet with the family and refer them to the appropriate services if necessary.
- What is the time commitment?
1.5 hours for the developmental assessment which will take place in the Cork University Hospital.
1 hour for the MRI brain (20 minutes scanning time) which will take place in the Cork University Hospital.
- What will happen to the results of this study?
The results of this study will be published in academic journals and presented at scientific meetings. You will never be identified individually during these presentations or any reports or publications. To ensure confidentiality, the data generated during this study is coded with a unique Study ID Number that will be allocated once your child is recruited to the study.
University College Cork (UCC) is the study’s Sponsor and will act as the data controller for this study. Any personal data which you provide to the University will be treated with the highest standards of security and confidentiality, in accordance with Irish and European Data Protection legislation.
- Where can I get more information?
If you have any further questions regarding this study, please contact Dr Anne Murray: SOPHIE@ucc.ie
- Interested in taking part in the study?
Fill out the enquiry form and a member of the research team will contact you: https://forms.office.com/e/1ajEMTUmDY
