Excipient Exposure, Neonatal, Pediatric
Conditions
Keywords
Ethanol, Propylene glycol, Benzyl alcohol, Acesulfam potassium, Aspartame, Glycerin, Sorbitol, Methyl-p-hydroxybenzoate, Propanyl-p-hydroxybenzoate, Patients
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.
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
Interventions
OTHERExposure to ethanol
The drug source(s) and amount administered daily are noted.
OTHERExposure to propylene glycol
The drug source(s) and amount administered daily are noted.
OTHERExposure to benzyl alcohol
The drug source(s) and amount administered daily are noted.
OTHERExposure to acesulfam potassium
The drug source(s) and amount administered daily are noted.
OTHERExposure to aspartame
The drug source(s) and amount administered daily are noted.
OTHERExposure to glycerol
The drug source(s) and amount administered daily are noted.
OTHERExposure to sorbitol
The drug source(s) and amount administered daily are noted.
OTHERExposure to methyl-p-hydroxybenzoate
The drug source(s) and amount administered daily are noted.
OTHERExposure to propanyl-p-hydroxybenzoate
The drug source(s) and amount administered daily are noted.
OTHERExposure to polysorbate-80
The drug source(s) and amount administered daily are noted.
Sponsors
Rigshospitalet, Denmark
Bispebjerg Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood alcohol content measured in per mille (grams of ethanol and propylene glycol pr. kilograms of blood) in the patient | Single day | Both concentrations of ethanol and propylene glycol are included in the calculations. with propylene glycol 1/3 as intoxicating as ethanol. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Identification of number of patient exposed to sodium-propyl-p-hydroxy-benzoate levels above tolerance levels proposed by international medicines agencies like EMA and FDA | Single day | Comparison of each patient daily exposure rate of sodium-propyl-p-hydroxy-benzoate to daily tolerance limit |
| Identification of number of patient exposed to sodium-methyl-p-hydroxy-benzoate levels above tolerance levels proposed by international medicines agencies like EMA and FDA | Single day | Comparison of each patient daily exposure rate of sodium-methyl-p-hydroxy-benzoate to daily tolerance limit |
| Identification of number of patient exposed to acesulfame potassium levels above tolerance levels proposed by international medicines agencies like EMA and FDA | Single day | Comparison of each patient daily exposure rate of acesulfame potassium to daily tolerance limit |
| 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 | The excipients (ethanol, propylene glycol, benzyl alcohol, methyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate, acesulfam potassium, aspartame, glycerol, polysorbate-80 and sorbitol) will be ranked according to which excipient is most often present in the medicine administered to the patients. |
| Identification of number of patient exposed to glycerol levels above tolerance levels proposed by international medicines agencies like EMA and FDA | Single day | Comparison of each patient daily exposure rate of glycerol to daily tolerance limit |
| Identification of number of patient exposed to sorbitol levels above tolerance levels proposed by international medicines agencies like EMA and FDA | Single day | Comparison of each patient daily exposure rate of sorbitol to daily tolerance limit |
| Identification of number of patient exposed to polysorbate-80 levels above tolerance levels proposed by international medicines agencies like EMA and FDA | Single day | Comparison of each patient daily exposure rate of polysorbate-80 to daily tolerance limit |
| Identification of number of patient exposed to aspartame levels above tolerance levels proposed by international medicines agencies like EMA and FDA | Single day | Comparison of each patient daily exposure rate of aspartame to daily tolerance limit |
| 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 | The excipients (ethanol, propylene glycol, benzyl alcohol, methyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate, acesulfam potassium, aspartame, glycerol, polysorbate-80 and sorbitol) will be ranked according to which excipient is most often present in the medicine administered to the patients. |
| 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 | The excipients (ethanol, propylene glycol, benzyl alcohol, methyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate, acesulfam potassium, aspartame, glycerol, polysorbate-80 and sorbitol) will be ranked according to which excipient is most often present in the medicine administered to the patients. |
| 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 | The excipients (ethanol, propylene glycol, benzyl alcohol, methyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate, acesulfam potassium, aspartame, glycerol, polysorbate-80 and sorbitol) will be ranked according to which excipient is most often present in the medicine administered to the patients. |
| Identification of number of patient exposed to ethanol levels above tolerance levels proposed by international medicines agencies like EMA and FDA | Single day | Comparison of each patient daily exposure rate of ethanol to daily tolerance limit |
| Identification of number of patient exposed to propylene glycol levels above tolerance levels proposed by international medicines agencies like EMA and FDA | Single day | Comparison of each patient daily exposure rate of proplyene glycol to daily tolerance limit |
| Identification of number of patient exposed to benzyl alcohol levels above tolerance levels proposed by international medicines agencies like EMA and FDA | Single day | Comparison of each patient daily exposure rate of benzyl alcohol to daily tolerance limit |
| Identification of number of patient exposed to methyl-p-hydroxy-benzoate levels above tolerance levels proposed by international medicines agencies like EMA and FDA | Single day | Comparison of each patient daily exposure rate of methyl-p-hydroxy-benzoate to daily tolerance limit |
| Identification of number of patient exposed to propyl-p-hydroxy-benzoate levels above tolerance levels proposed by international medicines agencies like EMA and FDA | Single day | Comparison of each patient daily exposure rate of propyl-p-hydroxy-benzoate to daily tolerance limit |
Outcome results
None listed