If a baby is mistakenly randomised to INIS is it still necessary to complete entry and discharge forms and arrange follow up?
A baby is considered randomised to INIS once the drug pack has been opened, regardless of whether any drug is infused. All such babies should have complete data collection including a 2 year follow-up because analysing study subjects in the groups to which they were initially randomised (intention to treat analysis) is the safest way of dealing with protocol violations that would otherwise bias the results.
