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

ABSTRACT:

Objective

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

Design

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

Setting

Twenty-one hospitals in the UK.

Participants

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

Intervention

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

Main outcome measure

The 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</

SUBMITTER: Hill M 

PROVIDER: S-EPMC10649701 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature