Pediatric Clinical Trial
Official title:
Safe Excipient Exposure in Neonates and Small ChildreN - a Retrospective, Descriptive Study Off the Amount of Ethanol, Propylene Glycol, Benzyl Alcohol, Parabens, Acesulfam k, Aspartame, Glycerol, Sorbitol and Polysorbate-80 Exposed to Pediatric Patients
The purpose of this study is to explore the quantity of excipient exposure in neonatal and young pediatric patients in a Danish Hospital. The focus will be on the preservatives ethanol, propyl glycol, benzyl alcohol, methyl-p-hydroxybenzoate and propanyl-p-hydroxybenzoate and the artificial sweeteners acesulfam potassium, aspartame, glycerol and sorbitol.
Studies have previously examined whether or not neonatal nor pediatric 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 a week after hospitalisation. The investigator will calculate
the blood alcohol content when the neonatal patient are exposed to ethanol and/or propylene
glycol.
By grouping the patients according to age and subgrouping 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 and/or pediatric 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 patient in each age-group is exposed to each excipient
- how much the average patient in each "affected organ system"-subgroup is exposed to
each excipient
;
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