The IgNiTE Study
A study testing a new treatment for children with encephalitis.
The Department of Paediatrics at the University of Oxford, in collaboration with NHS Trusts across the United Kingdom, is currently running a study for hospitalised children with encephalitis. The study will assess whether a treatment called intravenous immunoglobulin (IVIg, sometimes referred to as antibody treatment) has any benefit for these children when given early during the hospital admission.
It is unclear whether or not all children with encephalitis should be treated with IVIg and, as a result, there is a wide variation in practice. Some research studies have reported a beneficial effect of IVIg treatment for children with encephalitis, but these have either been small or only focused on certain types of encephalitis. . Furthermore, IVIg treatment is often delayed for a week or more while waiting for test results.
This trial is the first randomised controlled trial to study whether early IVIg treatment helps children with encephalitis. The study is funded by the UK National Institute for Health Research.
We aim to recruit 308 children with encephalitis aged from 6 weeks to 16 years, in approximately 30 UK hospitals. Participants will be randomly allocated to receive two intravenous doses of either IVIg or placebo in addition to other standard treatments. Each child will remain in the study for around 12 months.
Neurological outcomes will be assessed by questionnaires which will be completed at around 4-6 weeks after the participant has been discharged from acute care, and at around 6 and 12 months after treatment. There will also be a neuropsychology assessment carried out around 12 months after treatment.
The study will collect some medical information about participants and will test left over blood and spinal fluid samples collected as part of routine care. Some participants may have additional blood tests or a brain MRI scan, but these will be optional.
If you are interested in finding out more, please read the Study Information Booklet
If you would like any further information regarding the study please contact us on:
- Telephone (01865 857420)
- Email firstname.lastname@example.org
- Use the link provided on this website
The Oxford Vaccine Group
Study reference: 2014/05
Ethics reference: 14/SC/1416