NCT02545712

Safe Excipient Exposure in Neonates and Small ChildreN

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 630 (actual)
• Sponsor: Bispebjerg Hospital · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Excipient Exposure
• Neonatal
• Pediatric

Interventions

Type	Name	Description
OTHER	Exposure to ethanol	The drug source(s) and amount administered daily are noted.
OTHER	Exposure to propylene glycol	The drug source(s) and amount administered daily are noted.
OTHER	Exposure to benzyl alcohol	The drug source(s) and amount administered daily are noted.
OTHER	Exposure to acesulfam potassium	The drug source(s) and amount administered daily are noted.
OTHER	Exposure to aspartame	The drug source(s) and amount administered daily are noted.
OTHER	Exposure to glycerol	The drug source(s) and amount administered daily are noted.
OTHER	Exposure to sorbitol	The drug source(s) and amount administered daily are noted.
OTHER	Exposure to methyl-p-hydroxybenzoate	The drug source(s) and amount administered daily are noted.
OTHER	Exposure to propanyl-p-hydroxybenzoate	The drug source(s) and amount administered daily are noted.
OTHER	Exposure to polysorbate-80	The drug source(s) and amount administered daily are noted.

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-04-01
• First posted: 2015-09-10
• Last updated: 2017-02-07