Trial reportBMJ open2016
ImmunoglobuliN in the Treatment of Encephalitis (IgNiTE): protocol for a multicentre randomised controlled trial.
Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02308982 (A Phase III Multi-centre Randomised, Double Blind, Placebo Controlled Trial to Assess the Role of Intravenous Immunoglobulin in the Management of Children With Encephalitis), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase III Multi-centre Randomised, Double Blind, Placebo Controlled Trial to Assess the Role of Intravenous Immunoglobulin in the Management of Children With Encephalitis
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.
- How should we define a 'good' outcome from encephalitis? A systematic review of the range of outcome measures used in the long-term follow-up of patients with encephalitis.Clinical medicine (London, England) · 2022Pooled it
- Intravenous immunoglobulin treatment in childhood encephalitis (IgNiTE): a randomised controlled trial.BMJ open · 2023Trial
- Use of Intravenous Immunoglobulins in Pediatric Viral Meningoencephalitis: A Real-World Retrospective Observational Study.Journal of clinical medicine · 2026Article
- Immunotherapy responsiveness and risk of relapse in Down syndrome regression disorder.Translational psychiatry · 2023Observational
- Immunotherapy Responsiveness and Risk of Relapse in Down Syndrome Regression Disorder.Research square · 2023Article
- Functional Recovery in Autoimmune Encephalitis: A Prospective Observational Study.Frontiers in immunology · 2021Observational
- Autoimmune Encephalitis in Tunisia: Report of a Pediatric Cohort.Journal of immunology research · 2021Article
- Acute Disseminated Encephalomyelitis: Current Perspectives.Children (Basel, Switzerland) · 2020Review
- Bickerstaff's brainstem encephalitis associated with anti-GM1 and anti-GD1a antibodies.BMJ case reports · 2020Article
- Autoimmune Encephalitis: NMDA Receptor Encephalitis as an Example of Translational Neuroscience.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2020Review
- Herpes simplex virus infection, Acyclovir and IVIG treatment all independently cause gut dysbiosis.PloS one · 2020Article
- Bacteroides fragilis polysaccharide A induces IL-10 secreting B and T cells that prevent viral encephalitis.Nature communications · 2019Article
- Diagnosis and Management of Acute Encephalitis in Children.Indian journal of pediatrics · 2019Review
- An Update on the Treatment of Pediatric Autoimmune Encephalitis.Current treatment options in rheumatology · 2018Article
- Treatment strategies for autoimmune encephalitis.Therapeutic advances in neurological disorders · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 9 institutions in 2 countries.
Funding
Abstract
introductionInfectious and immune-mediated encephalitides are important but under-recognised causes of morbidity and mortality in childhood, with a 7% death rate and up to 50% morbidity after prolonged follow-up. There is a theoretical basis for ameliorating the immune response with intravenous immunoglobulin (IVIG), which is supported by empirical evidence of a beneficial response following its use in the treatment of viral and autoimmune encephalitis. In immune-mediated encephalitis, IVIG is often used after a delay (by weeks in some cases), while diagnosis is confirmed. Wider use of IVIG in infectious encephalitis and earlier use in immune-mediated encephalitis could improve outcomes for these conditions. We describe the protocol for the first ever randomised control trial of IVIG treatment for children with all-cause encephalitis. METHODS AND ANALYSIS: 308 children (6 months to 16 years) with a diagnosis of acute/subacute encephalitis will be recruited in ∼30 UK hospitals and randomised to receive 2 doses (1 g/kg/dose) of either IVIG or matching placebo, in addition to standard treatment. Recruitment will be over a 42-month period and follow-up of each participant will be for 12 months post randomisation. The primary outcome is 'good recovery' (score of 2 or lower on the Glasgow Outcome Score Extended-paediatric version), at 12 months after randomisation. Additional secondary neurological measures will be collected at 4-6 weeks after discharge from acute care and at 6 and 12 months after randomisation. Safety, radiological, other autoimmune and tertiary outcomes will also be assessed. ETHICS AND DISSEMINATION: This trial has been approved by the UK National Research Ethics committee (South Central-Oxford A; REC 14/SC/1416). Current protocol: V4.0 (10/03/2016). The findings will be presented at national and international meetings and conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBERS: NCT02308982, EudraCT201400299735 and ISRCTN15791925; Pre-results.
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.