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
试验速览
- 阶段
- 不适用
- 入组人数
- 630
- 主要终点
- Blood alcohol content measured in per mille (grams of ethanol and propylene glycol pr. kilograms of blood) in the patient
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •no up-dated weight is listed
- •> 5 years old
结局指标
主要结局
Blood alcohol content measured in per mille (grams of ethanol and propylene glycol pr. kilograms of blood) in the patient
时间窗: 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 polysorbate-80 in the patient
时间窗: Single day
Concentration (mg/kg/day) of acesulfam potassium in the patient
时间窗: Single day
Concentration (mg/kg/day) of aspartame in the patient
时间窗: Single day
Concentration (mg/kg/day) of glycerin in the patient
时间窗: Single day
Concentration (mg/kg/day) of propyl-p-hydroxybenzoate in the patient
时间窗: Single day
Concentration (mg/kg/day) of benzyl alcohol in the patient
时间窗: Single day
Concentration (mg/kg/day) of sorbitol in the patient
时间窗: Single day
Concentration (mg/l) of methyl-p-hydroxybenzoate in the patient
时间窗: Single day
次要结局
- 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)
- Identification of number of patient exposed to propylene glycol levels above tolerance levels proposed by international medicines agencies like EMA and FDA(Single day)
- Identification of number of patient exposed to benzyl alcohol levels above tolerance levels proposed by international medicines agencies like EMA and FDA(Single day)
- 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)
- 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)
- 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)
- Identification of number of patient exposed to sorbitol levels above tolerance levels proposed by international medicines agencies like EMA and FDA(Single day)
- 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)
- Identification of number of patient exposed to polysorbate-80 levels above tolerance levels proposed by international medicines agencies like EMA and FDA(Single day)
- Identification of number of patient exposed to aspartame levels above tolerance levels proposed by international medicines agencies like EMA and FDA(Single day)
- Identification of number of patient exposed to glycerol levels above tolerance levels proposed by international medicines agencies like EMA and FDA(Single day)
- Identification of number of patient exposed to acesulfame potassium levels above tolerance levels proposed by international medicines agencies like EMA and FDA(Single day)
研究者
Kristine Svinning Valeur
MS
Bispebjerg Hospital