Academic Lead: Prof. Neil Marlow (UCL)
Babies who have neonatal seizures are at high-risk of later developmental problems and disability. We will assess children who take part in NEMO at 2 years of age using a standardised assessment of development, neurology and quality of life as it relates to their health. In addition we will be looking in more detail at memory and behaviour, which may also on occasions be affected. This assessment is the end of the study for individuals.
Children will come from many different cultures and linguistic backgrounds and grow up in a range of healthcare systems. We will use assessments that are relevant to all children mindful of the great diversity of cultures in Europe. Al families will be asked for contact details before they go home so we can keep in touch.
This is our programme for the follow up phase:
At discharge home: Families will be given a diary, which also contains information about follow up arrangements and contact details. In this we will ask parents to record details of any illness and contacts with health professionals.
12-month visit: Families will be offered a routine appointment as per the local follow up system. The doctor will complete a simple disability assessment based on UK national recommendations, which will allow the classification of outcome into four categories (see below).
24-month visit: Families will be offered an appointment at a hospital or suitable clinic. A trained assessor will perform the assessment and complete a case record form (CRF) with details of the findings. Parents will be asked to complete a short questionnaire about their baby’s behaviour.
Alongside the health-based follow up we will collect information so we can also carry out a study to look at the costs of looking after children who received and did not receive bumetanide – using this information we can work out how “cost effective” the new treatment has been.
How do we ensure the assessments are consistent? We train all of the assessors in the same way at a 2-day course and then ask them to video themselves carrying out a “dummy” assessment so we can check they are doing the assessment correctly. We have to confirm their technique before they can start seeing study children. We also visit each centre and check assessments regularly.
Task 1: Agree the format of the assessments
Task 2: Prepare blank tables to check we are collecting the right data in the first 2y.
Task 3: Develop the patient diary
Task 4: Design of the study materials and training course (in conjunction with WP 02).
Task 5: Train the assessors (in conjunction with WP 02).
Task 6: Write a manual to ensure we all carry out the same type of examination.
Task 7: Collect and check all the results then analyse study outcomes with WP 11
Task 8: Develop a new protocol for longer-term follow up at 7 years and apply for funding
Task 9: Provide recommendations for social, economic and community resources required for improving health status in children with seizures in the neonatal period.