Secondary outcomes
glioma, haemolysis, epilepsy
GLIOMA, SECONDARY, EPILEPSY
Secondary clinical outcomes included admission to intensive care unit, requirement for invasive ventilation, length of acute hospital stay, new diagnoses of epilepsy and need for antiepileptic treatment in the 12 months after randomisation.Secondary neurological and functional outcomes comprised GOS-E Peds assessment at 6 months after randomisation, and Liverpool Outcome Score (LOS) assessment, Pediatric Quality of Life Score (PedsQL) assessment, Gross Motor Function and Classification System (GMFCS) assessment, Strengths and Difficulty Questionnaire (SDQ) assessment and Adaptive Behavior Assessment System—second edition (ABAS-II) assessment at 4–8 weeks after discharge from acute care and at 12 months after randomisation.Secondary neuropsychological outcomes were cognitive assessment at 12 months after randomisation using the age-appropriate scales: (1) Bayley Scales of Infant and Toddler Development, third edition (1 to 2 years 5 months); (2) Wechsler Preschool Primary Scale of Intelligence IV (2 years 6 months to 5 years 11 months), and (3) Wechsler Intelligence Scale for Children V (6 years to 16 years 11 months).The secondary neuroimmunology outcome was identification of autoantibodies. The antibodies tested for were for antibodies against live neurons, aquaporin 4, N-methyl-D-aspartate receptor, myelin oligodendrocyte glycoprotein (MOG), leucine-rich, glioma inactivated 1 (LGI1), and contactin-associated protein-like 2.Secondary neuroimaging outcomes comprised assessment of CT or MRI brain scans performed as part of routine care during the acute illness, and follow-up scans performed at 6 months after randomisation in a subset of participants, where consent was provided.Secondary safety outcomes included safety data obtained throughout the study, and a full blood count performed for all participants 24–48 hours following the second dose of the study treatment to monitor for haemolysis which has previously been described with high concentrations of IVIG treatment.Further information regarding to the secondary outcomes is provided in the 