Investigating the Role of Early Intravenous Immunoglobulin Treatment for Children With Encephalitis
Status:
Unknown status
Trial end date:
2020-02-01
Target enrollment:
Participant gender:
Summary
This is a phase III multi-centre randomised, double blind, placebo controlled trial to assess
the role of intravenous immunoglobulin in the treatment of children with encephalitis. The
primary objective is to find out whether early use of IVIG treatment improves neurological
outcomes of children with encephalitis.
308 children with encephalitis, aged 6 weeks to 16 years will be recruited in 30 hospitals in
the United Kingdom. Participants will be randomised to receive two doses of IVIG or matching
placebo in addition to other standard treatments, within the first five days of hospital
admission.
Each participant will be followed up for 12 months. During this period, information on
clinical, radiological and laboratory investigations will be collected. Neurological outcomes
will be assessed by the use of questionnaires at 6 and 12 months, and a neuropsychological
assessment at 12 months.
Phase:
Phase 3
Details
Lead Sponsor:
University of Oxford
Collaborators:
CSL Behring Great Ormond Street Hospital for Children NHS Foundation Trust Guy's and St Thomas' NHS Foundation Trust Liverpool University Hospitals NHS Foundation Trust National Institute for Health Research, United Kingdom Royal Liverpool and Broadgreen University Hospitals NHS Trust University College London Hospitals University of Liverpool