Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

630

participants targeted

Target at P75+ for all trials

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2015

Completed

7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed

4 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed

Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

1.2 years

First QC Date

September 3, 2015

Last Update Submit

February 4, 2017

Conditions

Excipient Exposure Neonatal Pediatric

Keywords

EthanolPropylene glycolBenzyl alcoholAcesulfam potassiumAspartameGlycerinSorbitolMethyl-p-hydroxybenzoatePropanyl-p-hydroxybenzoatePatients

Outcome Measures

Primary Outcomes (9)

Blood alcohol content measured in per mille (grams of ethanol and propylene glycol pr. kilograms of blood) in the patient
Both concentrations of ethanol and propylene glycol are included in the calculations. with propylene glycol 1/3 as intoxicating as ethanol.
Single day
Concentration (mg/kg/day) of benzyl alcohol in the patient
Single day
Concentration (mg/kg/day) of acesulfam potassium in the patient
Single day
Concentration (mg/kg/day) of aspartame in the patient
Single day
Concentration (mg/kg/day) of glycerin in the patient
Single day
Concentration (mg/kg/day) of sorbitol in the patient
Single day
Concentration (mg/l) of methyl-p-hydroxybenzoate in the patient
Single day
Concentration (mg/kg/day) of propyl-p-hydroxybenzoate in the patient
Single day
Concentration (mg/kg/day) of polysorbate-80 in the patient
Single day

Secondary Outcomes (16)

Identification of patient group (according to age-interval) most vulnerable to excipient exposure (measured in number of excipients)
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))
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)
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))
During the participants hospitalization, an expected average of 2 months
Identification of number of patient exposed to ethanol levels above tolerance levels proposed by international medicines agencies like EMA and FDA
Single day
+11 more secondary outcomes

Study Arms (2)

Neonatal patients

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.

Other: Exposure to ethanolOther: Exposure to propylene glycolOther: Exposure to benzyl alcoholOther: Exposure to acesulfam potassiumOther: Exposure to aspartameOther: Exposure to glycerolOther: Exposure to sorbitolOther: Exposure to methyl-p-hydroxybenzoateOther: Exposure to propanyl-p-hydroxybenzoateOther: Exposure to polysorbate-80

Pediatric patients (28 days ≤ 5 years)

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.