MERIDIAN 2-3 year follow up study
The MERIDIAN 2-3 year follow up study is open for recruitment.
The study is recruiting those children from the original MERIDIAN study, across all 15 of the sites.
There are 3 separate projects within the follow up study, all of which are designed to find out more about the development of the brains of those babies included in the original MERIDIAN study when they are 2-3 years old.
Project 1 will look to refine our estimates of how accurate the MR imaging technology is in identifying brain abnormalities in babies during pregnancy, based on clinical information gathered about these babies up to 42 months of age.
Project 2 will look to improve the information available to doctors and patients during pregnancy by using developmental assessment methods to see how the babies are functioning and developing.
Project 3 will look to assess how much of an impact isolated, mild ventriculomegaly (a condition where ventricles in the brain are enlarged) has on the functioning and development of the babies with the condition, using developmental assessment methods. Project 3 does not require any input from hospital staff or participants.
Mothers who participated in MERIDIAN, who had an MRI scan during pregnancy and whose child is two or more years old, will be contacted to see if they wish to take part in the follow up study. This contact will be from the hospital that they attended when they agreed to take part in the original study. Participants can choose to take part in Project 1 and Project 2, just Project 1, or to not participate at all. Children who are over 38 months of age will not be eligible to take part in Project 2.
If the participant wants to take part then the hospital will review their child’s clinical notes and collect information from any medical images taken from birth up to 42 months of age (Project 1). If they have also agreed to take part in project 2 then a suitable time and place will be arranged for the development assessment of their child to take place (Project 2). If a suitable time and place for the assessment cannot be arranged then participants have the option to complete a questionnaire and post it back to the study team or they can arrange to answer the questions over the telephone. After both projects, parents will be sent a letter to let them know that they have completed in the study and will include details of the findings if applicable.
Finally, the central MERIDIAN study team will look closely at cases of babies diagnosed with isolated, mild ventriculomegaly during the original study and assess their development (Project 3), using data obtained from Project 2. This element of the study requires no input from hospital staff or participants.
The purpose of this follow-up study is to improve and refine our estimates of diagnostic accuracy and prognosis using data available when the children of the MERIDIAN cohort are aged 2-3 years. To avoid causing emotional upset or distress by contacting the family of a deceased child we will be using data from the Health and Social Care Information Centre. Where the parents have agreed to be contacted for future follow up about their child’s development we will provide the Health and Social Care Information Centre with the date of birth, NHS number and unique participant ID number of the children in our study. They will then return to us the unique participant ID number along with the fact of death, where applicable. We will not make contact with the family of a deceased child.
If you are a member of the MERIDIAN cohort, and would like to opt out of your data being collected, please contact the Study Manager, Cara Mooney on the details provided below.
If you would like further information then you can phone the Study Manager, Cara Mooney, on 0114 222 4308 or email email@example.com.
Alternatively, if you are a MERIDIAN participant you can also contact your local research team at the hospital where you originally agreed to take part in MERIDIAN.
Funder: This project is funded by the NIHR Health Technology Assessment (HTA) programme (project number 09/06/01), with the support of the Comprehensive Clinical Research Network. A full project report will be published in Health Technology Assessment. Any views or opinions expressed are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.