Overview

This trial is active, not recruiting.

Conditions excipient exposure, neonatal, pediatric
Treatments exposure to ethanol, exposure to propylene glycol, exposure to benzyl alcohol, exposure to acesulfam potassium, exposure to aspartame, exposure to glycerol, exposure to sorbitol, exposure to methyl-p-hydroxybenzoate, exposure to propanyl-p-hydroxybenzoate, exposure to polysorbate-80
Sponsor Bispebjerg Hospital
Collaborator Rigshospitalet, Denmark
Start date January 2016
End date October 2016
Trial size 200 participants
Trial identifier NCT02545712, BBH-KSV-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective retrospective
Arm
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.
exposure to ethanol Ethyl achohol
The drug source(s) and amount administered daily are noted.
exposure to propylene glycol
The drug source(s) and amount administered daily are noted.
exposure to benzyl alcohol
The drug source(s) and amount administered daily are noted.
exposure to acesulfam potassium Acesulfame-K
The drug source(s) and amount administered daily are noted.
exposure to aspartame
The drug source(s) and amount administered daily are noted.
exposure to glycerol Glycerol
The drug source(s) and amount administered daily are noted.
exposure to sorbitol
The drug source(s) and amount administered daily are noted.
exposure to methyl-p-hydroxybenzoate including sodium-methyl-p-hydroxybenzoate
The drug source(s) and amount administered daily are noted.
exposure to propanyl-p-hydroxybenzoate including sodium-propanyl-p-hydroxybenzoate
The drug source(s) and amount administered daily are noted.
exposure to polysorbate-80
The drug source(s) and amount administered daily are noted.
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.
exposure to ethanol Ethyl achohol
The drug source(s) and amount administered daily are noted.
exposure to propylene glycol
The drug source(s) and amount administered daily are noted.
exposure to benzyl alcohol
The drug source(s) and amount administered daily are noted.
exposure to acesulfam potassium Acesulfame-K
The drug source(s) and amount administered daily are noted.
exposure to aspartame
The drug source(s) and amount administered daily are noted.
exposure to glycerol Glycerol
The drug source(s) and amount administered daily are noted.
exposure to sorbitol
The drug source(s) and amount administered daily are noted.
exposure to methyl-p-hydroxybenzoate including sodium-methyl-p-hydroxybenzoate
The drug source(s) and amount administered daily are noted.
exposure to propanyl-p-hydroxybenzoate including sodium-propanyl-p-hydroxybenzoate
The drug source(s) and amount administered daily are noted.
exposure to polysorbate-80
The drug source(s) and amount administered daily are noted.

Primary Outcomes

Measure
Blood alcohol content measured in per mille (grams of ethanol and propylene glycol pr. kilograms of blood) in the patient
time frame: Single day
Concentration (mg/l) of benzyl alcohol in the patient
time frame: Single day
Concentration (mg/l) of acesulfam potassium in the patient
time frame: Single day
Concentration (mg/l) of aspartame in the patient
time frame: Single day
Concentration (mg/l) of glycerin in the patient
time frame: Single day
Concentration (mg/l) of sorbitol in the patient
time frame: Single day
Concentration (mg/l) of methyl-p-hydroxybenzoate in the patient
time frame: Single day
Concentration (mg/l) of propanyl-p-hydroxybenzoate in the patient
time frame: Single day

Secondary Outcomes

Measure
Identification of patient group (according to age-interval) most vulnerable to excipient exposure (measured in number of excipients)
time frame: During the participants hospitalization, an expected average of 2 months
Identification of patient group (according to age-interval) most vulnerable to excipient exposure (amounts of each excipient measured in (mg/l))
time frame: During the participants hospitalization, an expected average of 2 months
Identification of patient group (according to affected organ system) most vulnerable to excipient exposure (measured in number of excipients)
time frame: During the participants hospitalization, an expected average of 2 months
Identification of patient group (according to affected organ system) most vulnerable to excipient exposure (amounts of each excipient measured in (mg/l))
time frame: During the participants hospitalization, an expected average of 2 months

Eligibility Criteria

Male or female participants up to 5 years old.

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

Additional Information

Official title Safe Excipient Exposure in Neonates and Small ChildreN - a Retrospective, Descriptive Study Off the Amount of Ethanol, Propylene Glycol, Benzyl Alcohol, Benzoates, Acesulfam k, Aspartame, Glycerol and Sorbitol Exposed to Pediatric Patients
Principal investigator Kristine Svinning Valeur, MS
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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Bispebjerg Hospital.