Safe Excipient Exposure in Neonates

2015-09-14 03:14:40 | BioPortfolio


The purpose of this study is to explore the quantity of excipient exposure in neonatal patients in a Danish Hospital. The focus will be on the preservatives ethanol, propyl glycol and benzyl alcohol and the artificial sweeteners acesulfam potassium, aspartame and glycerol.


Studies have previously examined whether or not neonatal patients are exposed to excipients and what excipients they are possibly exposed to. They have shown that practically all neonatal patients receive one or more drug containing an excipient, known to be harmful. This observational study will look at both registered drugs and extemporaneous pharmaceuticals as possible sources of excipients. Based on information provided by the manufacturer (ex. the index-list), the investigator will calculate the amounts of excipients administered to the patient when they receive ≥10 drugs. The investigator will calculate the blood alcohol content when the neonatal patient are exposed to ethanol and/or propylene glycol.

By grouping the neonatal patients according to diagnosis/affected organ system and compare the amount of excipient exposure in each group, the study aims at identifying the most vulnerable neonatal patients in terms of the amount and identity of excipients accumulated in the patient.

The study will use a descriptive, parametric statistic analysis to identify

- an average exposure rate (concentration i mg/l or amount in mg) of each of the listed excipients

- how much the average neonatal patient in each "affected organ system"-groups is exposed to each excipient

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Excipient Exposure


Exposure to ethanol, Exposure to propylene glycol, Exposure to benzyl alcohol, Exposure to acesulfam potassium, Exposure to aspartame, Exposure to glycerin


Not yet recruiting


Bispebjerg Hospital

Results (where available)

View Results


Published on BioPortfolio: 2015-09-14T03:14:40-0400

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