Is it in a neonate's best interest to enter a randomised controlled trial?

Clinicians are required to act in the best interest of neonates. However, i t is not obvious that entry into a randomised controlled trial (RCT) is in a neonate's best interest because such trials often involve additional oner ous procedures (such as intramuscular injections) in return for which the n eonate receives unproven treatment or a placebo On the other hand, neonatol ogy needs to develop its evidence base, and RCTs are central to this task. The solution posited here is based on two points. First, "best interest" is nor equivalent to "the best possible interest" only to "best interest with in a certain realm". The realm of deliberation when asking the title questi on is the neonate's health. Deliberating in this realm may involve the excl usion from consideration of some factors that might be thought relevant (su ch as parental wealth). Furthermore, circumstances may dictate the need to deliberate on other factors that might be thought irrelevant (such as healt h care resources). Second, deciding on a neonate's best interest does not i nvolve "putting oneself in its shoes". Rather, it involves asking in what i t has an interest, or stake. These will include some things in which we all , as human beings, have a stake, such as medical progress. Putting these tw o points together, in the realm of health the answer to whether RCT entry i s in a neonate's best interest is usually very finely, balanced. Where this is the case, it is reasonable to invoke a broader notion of best interest and include a broader range of elements in which the neonate has a stake, i ncluding medical progress. In this way RCT entry can, usually, be said to b e in a neonate's best interest.