Allocation of the participants in the study group

How is it possible to measure the efficacy of the drug?

In this study two different treatments will be compared to each other. This is to be achieved by one group receiving a placebo, which is an inactive substance e.g. a saline, which does no harm, and one group receiving the actual medication. Therefore, all patients will be allocated to one of two groups.

How does the allocation work?

A computer will be used to assign study participants into treatment groups by chance. This is called randomisation and can be compared to drawing lots. A baby has a 1 in 2 chance of being placed in either group. Neither the participants, nor the study team will know which treatment a baby receives (this is called double-blind). This is to make sure the results of each group being studied are handled in the
same way.