Secondary neurological and functional outcomes
Outcome | 4–8 weeks post discharge | 12 months post randomisation | ||
IVIG (n=10) | Placebo (n=8) | IVIG (n=10) | Placebo (n=8) | |
LOS | ||||
Severe sequelae | 2 (20%) | 2 (25%) | 2 (20%) | 2 (25%) |
Moderate sequelae | 2 (20%) | 3 (38%) | 1 (10%) | 1 (13%) |
Minor sequelae | 1 (10%) | 0 (0%) | 1 (10%) | 1 (3%) |
Full recovery | 3 (30%) | 2 (25%) | 4 (40%) | 2 (25%) |
Missing data due to withdrawal or loss to follow-up of participant | 1 (10%) | 1 (13%) | 2 (20%) | 2 (25%) |
Missing data—assessment not performed | 1 (10%) | 0 (0%) | 0 (%) | 0 (%) |
PedsQL | ||||
Mean (SD) | 77.9 (11.1) | 56.5 (7.8) | 79.9 (21.6) | 63.7 (30.1) |
Missing data due to withdrawal or loss to follow-up of participant | 1 (10%) | 1 (13%) | 2 (20%) | 2 (25%) |
Missing data—assessment not performed | 4 (40%) | 5 (63%) | 2 (20%) | 4 (50%) |
SDQ | ||||
Close to average | 4 (40%) | 1 (13%) | 4 (40%) | 1 (13%) |
Slightly raised | 1 (10%) | 0 (0%) | 1 (10%) | 0 (0%) |
Very high | 0 (0%) | 1 (13%) | 1 (10%) | 1 (13%) |
Missing data due to withdrawal or loss to follow-up of participant | 1 (10%) | 1 (13%) | 2 (20%) | 2 (25%) |
Missing data—assessment not performed | 4 (40%) | 5 (63%) | 2 (20%) | 4 (50%) |
ABAS | ||||
Very superior | 0 (0%) | 0 (0%) | 1 (10%) | 0 (0%) |
Superior | 1 (10%) | 0 (0%) | 1 (10%) | 0 (0%) |
Above average | 1 (10%) | 0 (0%) | 1 (10%) | 0 (0%) |
Average | 2 (20%) | 1 (13%) | 0 (0%) | 1 (13%) |
Below average | 0 (0%) | 1 (13%) | 1 (10%) | 0 (0%) |
Borderline | 1 (10%) | 0 (0%) | 0 (0%) | 0 (0%) |
Extremely low | 1 (10%) | 0 (0%) | 1 (10%) | 1 (13%) |
Missing data due to withdrawal or loss to follow-up of participant | 1 (10%) | 1 (13%) | 2 (20%) | 2 (25%) |
Missing data—assessment not performed | 3 (30%) | 5 (63%) | 3 (30%) | 4 (50%) |
GMFCS* | ||||
Mild | 5 (50%) | 2 (25%) | 6 (60%) | 1 (13%) |
Severe | 0 (0%) | 1 (13%) | ||
Missing data due to withdrawal or loss to follow-up of participant | 1 (10%) | 1 (13%) | 2 (20%) | 2 (25%) |
Missing data—assessment not performed | 4 (40%) | 5 (63%) | 2 (20%) | 4 (50%) |
GOSE-Peds at 6 months post randomisation | ||
IVIG (n=10) | Placebo (n=8) | |
Upper good recovery | 4 (40%) | 4 (50%) |
Upper moderate disability | 1 (10%) | 1 (13%) |
Upper severe disability | 0 (0%) | 1 (13%) |
Lower severe disability | 3 (30%) | 1 (13%) |
Missing data due to withdrawal or loss to follow-up of participant | 2 (20%) | 1 (13%) |
Missing data—assessment not performed | 0 (0%) | 0 (0%) |
ABAS, Adaptive Behavior Assessment System; GMFCS, Gross Motor and Function Classification System; GOSE-Peds, Paediatric Glasgow Outcome Score Extended; LOS, Liverpool Outcome Score; SDQ, Strengths and Difficulty Questionnaire.