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Very small numbers of clinical trials are held in neonates; there are 378 listed as ongoing on the EU Clinical Trials Register in preterm infants and newborns, as opposed
to 2013 in adolescents (EU Clinical Trials Register, 2021). An ongoing perception is that these trials have too many ethical and practical issues to be feasible. This whitepaper addresses some of the issues researchers may face when undertaking trials in this unique population.