Our neonatal unit would be interested in participating in INIS but we occasionally use open-label immunoglobulin in the very sickest babies. Can we still be included?
Yes. We stress that babies randomised to INIS should NOT receive any open-label IVIG for the duration of stay on the unit as this has the potential to contaminate the study results. Clinicians who wish to use open label IVIG for babies outside of the study should first check whether the baby is eligible for INIS. There is insufficient evidence to support the use of IVIG otherwise, hence the justification for the study.
