Safe Excipient Exposure in Neonates and Small ChildreN (SEEN)

Bispebjerg Hospital

Status: Unknown

Conditions: Excipient Exposure; Neonatal; Pediatric

Treatments: Other: Exposure to sorbitol; Other: Exposure to benzyl alcohol; Other: Exposure to methyl-p-hydroxybenzoate; Other: Exposure to glycerol; Other: Exposure to propylene glycol; Other: Exposure to acesulfam potassium; Other: Exposure to aspartame; Other: Exposure to polysorbate-80; Other: Exposure to ethanol; Other: Exposure to propanyl-p-hydroxybenzoate

Study type: Observational

Funder types: Other

Identifiers

NCT02545712

BBH-KSV-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 630 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• if < 28 days: must receive 2 or more prescriptions a day
• if 28 days ≤ 5 years: must receive 3 or more prescriptions a day
• must have been/be submitted and treated at the neonatal department (units 5021, 5023, 5024) or pediatric department (units 5061, 5062, 5054, 4144) of Rigshospitalet

Exclusion criteria

• no up-dated weight is listed
• > 5 years old

Trial design

630 participants in 2 patient groups

Neonatal patients

Description:

Receiving 2 or more drugs at one day during their hospitalisation. For each drug, it is listed whether it is an extemporaneous, registered, the preparation, dosis, amount, interval, formulation and route of administration. It is noted if the drug contains ethanol, propylene glycol, benzyl alcohol, methyl-p-hydroxybenzoate, propanyl-p-hydroxybenzoate, acesulfam potassium, aspartame, glycerin and/or sorbitol.

Treatment:

Other: Exposure to propanyl-p-hydroxybenzoate

Other: Exposure to sorbitol

Other: Exposure to ethanol

Other: Exposure to polysorbate-80

Other: Exposure to benzyl alcohol

Other: Exposure to acesulfam potassium

Other: Exposure to propylene glycol

Other: Exposure to aspartame

Other: Exposure to glycerol

Other: Exposure to methyl-p-hydroxybenzoate

Pediatric patients (28 days ≤ 5 years)

Description:

Receiving 3 or more drugs at one day during their hospitalisation. For each drug, it is listed whether it is an extemporaneous, registered, the preparation, dosis, amount, interval, formulation and route of administration. It is noted if the drug contains ethanol, propylene glycol, benzyl alcohol, methyl-p-hydroxybenzoate, propanyl-p-hydroxybenzoate, acesulfam potassium, aspartame, glycerin and/or sorbitol.

Treatment:

Other: Exposure to propanyl-p-hydroxybenzoate

Other: Exposure to sorbitol

Other: Exposure to ethanol

Other: Exposure to polysorbate-80

Other: Exposure to benzyl alcohol

Other: Exposure to acesulfam potassium

Other: Exposure to propylene glycol

Other: Exposure to aspartame

Other: Exposure to glycerol

Other: Exposure to methyl-p-hydroxybenzoate