Evidence map›Paper›PMID 37945292›Full record

Trial reportBMJ open2023

Intravenous immunoglobulin treatment in childhood encephalitis (IgNiTE): a randomised controlled trial.

Matilda Hill, Mildred Iro, Manish Sadarangani, Michael Absoud, Liberty Cantrell, Kling Chong, Christopher Clark, Ava Easton, Victoria Gray, Rachel Kneen and 9 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2023. 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.2field-weighted citation impact, top 19% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT02308982 phase3completednot on this map

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

TypeinterventionalSponsorUniversity of OxfordRan2016 to 2022Enrolled18ConditionsEncephalitisArmsImmunoglobulins, Intravenous (Privigen), Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
  3. Case report: a co-occurring case of severeFrontiers in medicine · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 7 institutions in 2 countries.

Matilda Hill *Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK matilda.hill@paediatrics.ox.ac.uk.ORCID 0000-0002-1566-2512
Mildred Iro *Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Manish SadaranganiOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Michael AbsoudChildren's Neurosciences, Evelina London Children's Hospital Neurosciences Department, London, UK.
Liberty CantrellOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Kling ChongUCL Great Ormond Street Institute of Child Health, London, UK.
Christopher ClarkUCL Great Ormond Street Institute of Child Health, London, UK.
Ava EastonThe Encephalitis Society, Malton, North Yorkshire, UK.
Victoria GrayClinical Health Psychology, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.
Rachel KneenDepartment of Neurology, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.
Ming LimChildren's Neurosciences, Evelina London Children's Hospital Neurosciences Department, London, UK.
Xinxue LiuOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.ORCID 0000-0003-1107-0365
Michael PikeDepartment of Paediatric Neurology, Oxford University Hospitals NHS Trust, Oxford, UK.
Tom SolomonInstitute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Liverpool, UK.
Angela VincentNuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.
Louise WillisOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
Ly-Mee YuNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Andrew J PollardOxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.ORCID 0000-0001-7361-719X
IgNiTE study team
University of Oxford · GBUniversity of Liverpool · GBGreat Ormond Street Hospital · GBKing's College London · GBAlder Hey Children's NHS Foundation Trust · GBOxford University Hospitals NHS Trust · GBUniversity of British Columbia · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate whether intravenous immunoglobulin (IVIG) improves neurological outcomes in children with encephalitis when administered early in the illness.

designPhase 3b multicentre, double-blind, randomised placebo-controlled trial.

settingTwenty-one hospitals in the UK.

participantsChildren aged 6 months to 16 years with a diagnosis of acute or subacute encephalitis, with a planned sample size of 308.

interventionTwo doses (1 g/kg/dose) of either IVIG or matching placebo given 24-36 hours apart, in addition to standard treatment.

main outcome measureThe primary outcome was a 'good recovery' at 12 months after randomisation, defined as a score of≤2 on the Paediatric Glasgow Outcome Score Extended. SECONDARY OUTCOME MEASURES: The secondary outcomes were clinical, neurological, neuroimaging and neuropsychological results, identification of the proportion of children with immune-mediated encephalitis, and IVIG safety data.

results18 participants were recruited from 12 hospitals and randomised to receive either IVIG (n=10) or placebo (n=8) between 23 December 2015 and 26 September 2017. The study was terminated early following withdrawal of funding due to slower than anticipated recruitment, and therefore did not reach the predetermined sample size required to achieve the primary study objective; thus, the results are descriptive. At 12 months after randomisation, 9 of the 18 participants (IVIG n=5/10 (50%), placebo n=4/8 (50%)) made a good recovery and 5 participants (IVIG n=3/10 (30%), placebo n=2/8 (25%)) made a poor recovery. Three participants (IVIG n=1/10 (10%), placebo n=2/8 (25%)) had a new diagnosis of epilepsy during the study period. Two participants were found to have specific autoantibodies associated with autoimmune encephalitis. No serious adverse events were reported in participants receiving IVIG.

conclusionsThe IgNiTE (ImmunoglobuliN in the Treatment of Encephalitis) study findings support existing evidence of poor neurological outcomes in children with encephalitis. However, the study was halted prematurely and was therefore underpowered to evaluate the effect of early IVIG treatment compared with placebo in childhood encephalitis. TRIAL REGISTRATION NUMBER: Clinical Trials.gov NCT02308982; ICRCTN registry ISRCTN15791925.

Indexed as

EncephalitisHashimoto DiseaseAdministration, IntravenousAdolescentChildChild, PreschoolDouble-Blind MethodHumansImmunoglobulins, IntravenousInfantTreatment OutcomeImmunoglobulins, Intravenousclinical trialsdevelopmental neurology & neurodisabilitypaediatric infectious disease & immunisationpaediatric neurology

Identifiers

PMID37945292
PMCPMC10649701
OpenAlexW4388578670

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.