Safe excipient exposure in neonates and small children - protocol for the SEEN project.

INTRODUCTION: The pharmacokinetics of excipients in neonates differs from that of older children. In a recent pan--European survey, two thirds of neonates received at least one potentially harmful excipient, such as ethanol and benzoates. The content of sweeteners varied by route of administration (more common by enteral than parenteral route), and regional differences were revealed. The survey did not identify if the content of excipients was more pronounced in medications prescribed for specific medical diseases, e.g. more common in cardiovascular conditions than lung diseases. Furthermore, the quantitative amount of e.g. ethanol in the multi-medicated neonate has not been investigated. The aim of the present study was to quantify the total amount of excipients administered to poly-medicated neonatal and paediatric patients during hospitalisation; and to investigate if any particular medical diseases are treated with potentially harmful excipients.

METHODS: This is a retrospective cohort study based on chart-audit on multi-medicated patients ≤ 5 years of age treated at the Rigshospitalet, Denmark. Preparations with ethanol, propylene glycol, benzyl alcohol, parabens, acesulfame p, aspartame, glycerol, sorbitol and polysorbate-80 will be recorded and cumulative amounts will be calculated.

CONCLUSION: By quantifying the amount of harmful excipients to which paediatric patients are exposed, the study will contribute to a risk/benefit assessment of the medication standards of neonatal and paediatric patients.

FUNDING: The Danish Council for Independent Research, grant-id: DFF - 6110-00266.

TRIAL REGISTRATION: This study was registered at clinicaltrials.gov (reg. no. NCT02545712).