Excipient ExposureSEENNCT02545712
Safe Excipient Exposure in Neonates and Small ChildreN
An observational study of Excipient Exposure and Neonatal, run by Bispebjerg Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Excipient Exposure, Neonatal, Pediatric
- What is being tested?
- Exposure to ethanol, Exposure to propylene glycol and Exposure to benzyl alcohol
- How many people
- 630 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Neonatal patients and pediatric patients (≤ 5 years) who, at one point, have been/are being treated at the "Neonatalklinikken" (units 5021, 5023, 5024) or "BørneUngeklinikken" (units 5061, 5062, 5054, 4144) of Rigshospitalet, Denmark. To be included in the study, the patients must receive * 2 or more different drugs if < 28 days old * 3 or more different drugs if 28 day ≤ 5 years old
Who may be able to join
- 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
Who cannot join
- no up-dated weight is listed
- > 5 years old
About this study
Official title: 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
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.
Read the 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
- Conditions
- Excipient Exposure, Neonatal, Pediatric
- Being tested
- Exposure to ethanol, Exposure to propylene glycol, Exposure to benzyl alcohol, Exposure to acesulfam potassium, Exposure to aspartame
- Keywords
- Ethanol, Propylene glycol, Benzyl alcohol, Acesulfam potassium, Aspartame, Glycerin, Sorbitol, Methyl-p-hydroxybenzoate, Propanyl-p-hydroxybenzoate, Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to ethanolOther
Also called Ethyl achohol
The drug source(s) and amount administered daily are noted.
Exposure to propylene glycolOther
The drug source(s) and amount administered daily are noted.
Exposure to benzyl alcoholOther
The drug source(s) and amount administered daily are noted.
Exposure to acesulfam potassiumOther
Also called Acesulfame-K
The drug source(s) and amount administered daily are noted.
Exposure to aspartameOther
The drug source(s) and amount administered daily are noted.
Exposure to glycerolOther
Also called Glycerol
The drug source(s) and amount administered daily are noted.
Exposure to sorbitolOther
The drug source(s) and amount administered daily are noted.
Exposure to methyl-p-hydroxybenzoateOther
Also called including sodium-methyl-p-hydroxybenzoate
The drug source(s) and amount administered daily are noted.
Exposure to propanyl-p-hydroxybenzoateOther
Also called including sodium-propanyl-p-hydroxybenzoate
The drug source(s) and amount administered daily are noted.
Exposure to polysorbate-80Other
The drug source(s) and amount administered daily are noted.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exposure to ethanol; Other: Exposure to propylene glycol; Other: Exposure to benzyl alcohol; Other: Exposure to acesulfam potassium; Other: Exposure to aspartame; Other: Exposure to glycerol; Other: Exposure to sorbitol; Other: Exposure to methyl-p-hydroxybenzoate; Other: Exposure to propanyl-p-hydroxybenzoate; Other: 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. Receives: Other: Exposure to ethanol; Other: Exposure to propylene glycol; Other: Exposure to benzyl alcohol; Other: Exposure to acesulfam potassium; Other: Exposure to aspartame; Other: Exposure to glycerol; Other: Exposure to sorbitol; Other: Exposure to methyl-p-hydroxybenzoate; Other: Exposure to propanyl-p-hydroxybenzoate; Other: Exposure to polysorbate-80 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single day
Concentration (mg/kg/day) of benzyl alcohol in the patient
Measured: Single day
Concentration (mg/kg/day) of acesulfam potassium in the patient
Measured: Single day
Concentration (mg/kg/day) of aspartame in the patient
Measured: Single day
Concentration (mg/kg/day) of glycerin in the patient
Measured: Single day
Concentration (mg/kg/day) of sorbitol in the patient
Measured: Single day
Concentration (mg/l) of methyl-p-hydroxybenzoate in the patient
Measured: Single day
Concentration (mg/kg/day) of propyl-p-hydroxybenzoate in the patient
Measured: Single day
Concentration (mg/kg/day) of polysorbate-80 in the patient
Measured: Single day
Secondary outcomes (16)
Identification of patient group (according to age-interval) most vulnerable to excipient exposure (measured in number of excipients)
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.
Measured: 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))
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.
Measured: 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)
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.
Measured: 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))
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.
Measured: 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
Comparison of each patient daily exposure rate of ethanol to daily tolerance limit
Measured: Single day
Identification of number of patient exposed to propylene glycol levels above tolerance levels proposed by international medicines agencies like EMA and FDA
Comparison of each patient daily exposure rate of proplyene glycol to daily tolerance limit
Measured: Single day
Identification of number of patient exposed to benzyl alcohol levels above tolerance levels proposed by international medicines agencies like EMA and FDA
Comparison of each patient daily exposure rate of benzyl alcohol to daily tolerance limit
Measured: 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
Comparison of each patient daily exposure rate of methyl-p-hydroxy-benzoate to daily tolerance limit
Measured: 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
Comparison of each patient daily exposure rate of propyl-p-hydroxy-benzoate to daily tolerance limit
Measured: 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
Comparison of each patient daily exposure rate of sodium-propyl-p-hydroxy-benzoate to daily tolerance limit
Measured: 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
Comparison of each patient daily exposure rate of sodium-methyl-p-hydroxy-benzoate to daily tolerance limit
Measured: Single day
Identification of number of patient exposed to acesulfame potassium levels above tolerance levels proposed by international medicines agencies like EMA and FDA
Comparison of each patient daily exposure rate of acesulfame potassium to daily tolerance limit
Measured: Single day
Identification of number of patient exposed to aspartame levels above tolerance levels proposed by international medicines agencies like EMA and FDA
Comparison of each patient daily exposure rate of aspartame to daily tolerance limit
Measured: Single day
Identification of number of patient exposed to glycerol levels above tolerance levels proposed by international medicines agencies like EMA and FDA
Comparison of each patient daily exposure rate of glycerol to daily tolerance limit
Measured: Single day
Identification of number of patient exposed to sorbitol levels above tolerance levels proposed by international medicines agencies like EMA and FDA
Comparison of each patient daily exposure rate of sorbitol to daily tolerance limit
Measured: Single day
Identification of number of patient exposed to polysorbate-80 levels above tolerance levels proposed by international medicines agencies like EMA and FDA
Comparison of each patient daily exposure rate of polysorbate-80 to daily tolerance limit
Measured: Single day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startJan 2016
- Primary completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Excipient ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Kristine Svinning Valeur, Bispebjerg Hospital
- Investigators
- Kristine Svinning Valeur, MS, Principal investigator, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545712
- Sponsor's protocol ID
- BBH-KSV-01
- Acronym
- SEEN
- Status last verified
- Feb 2017
- First submitted
- 3 Sep 2015
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nellis G, Metsvaht T, Varendi H, Toompere K, Lass J, Mesek I, Nunn AJ, Turner MA, Lutsar I; ESNEE consortium. Potentially harmful excipients in neonatal medicines: a pan-European observational study. Arch Dis Child. 2015 Jul;100(7):694-9. doi: 10.1136/archdischild-2014-307793. Epub 2015 Apr 8.
PubMed 25854872Souza A Jr, Santos D, Fonseca S, Medeiros M, Batista L, Turner M, Coelho H. Toxic excipients in medications for neonates in Brazil. Eur J Pediatr. 2014 Jul;173(7):935-45. doi: 10.1007/s00431-014-2272-z. Epub 2014 Feb 6.
PubMed 24500397Marek E, Kraft WK. Ethanol pharmacokinetics in neonates and infants. Curr Ther Res Clin Exp. 2014 Oct 22;76:90-7. doi: 10.1016/j.curtheres.2014.09.002. eCollection 2014 Dec.
PubMed 25379066Nguyen KA, Claris O, Kassai B. Unlicensed and off-label drug use in a neonatal unit in France. Acta Paediatr. 2011 Apr;100(4):615-7. doi: 10.1111/j.1651-2227.2010.02103.x. Epub 2010 Dec 17. No abstract available.
PubMed 21410525Jacqz-Aigrain E. Drug policy in Europe Research and funding in neonates: current challenges, future perspectives, new opportunities. Early Hum Dev. 2011 Mar;87 Suppl 1:S27-30. doi: 10.1016/j.earlhumdev.2011.01.007. Epub 2011 Jan 26.
PubMed 21269785Allegaert K. Neonates need tailored drug formulations. World J Clin Pediatr. 2013 Feb 8;2(1):1-5. doi: 10.5409/wjcp.v2.i1.1. eCollection 2013 Feb 8.
PubMed 25254168Bellis JR, Kirkham JJ, Thiesen S, Conroy EJ, Bracken LE, Mannix HL, Bird KA, Duncan JC, Peak M, Turner MA, Smyth RL, Nunn AJ, Pirmohamed M. Adverse drug reactions and off-label and unlicensed medicines in children: a nested case-control study of inpatients in a pediatric hospital. BMC Med. 2013 Nov 7;11:238. doi: 10.1186/1741-7015-11-238.
PubMed 24229060Nahata MC. Safety of "inert" additives or excipients in paediatric medicines. Arch Dis Child Fetal Neonatal Ed. 2009 Nov;94(6):F392-3. doi: 10.1136/adc.2009.160192. No abstract available.
PubMed 19846397Whittaker A, Currie AE, Turner MA, Field DJ, Mulla H, Pandya HC. Toxic additives in medication for preterm infants. Arch Dis Child Fetal Neonatal Ed. 2009 Jul;94(4):F236-40. doi: 10.1136/adc.2008.146035. Epub 2009 Jan 21.
PubMed 19158148Saiyed MM, Lalwani T, Rana D. Is off-label use a risk factor for adverse drug reactions in pediatric patients? A prospective study in an Indian tertiary care hospital. Int J Risk Saf Med. 2015;27(1):45-53. doi: 10.3233/JRS-150642.
PubMed 25766066Collison KS, Makhoul NJ, Zaidi MZ, Al-Rabiah R, Inglis A, Andres BL, Ubungen R, Shoukri M, Al-Mohanna FA. Interactive effects of neonatal exposure to monosodium glutamate and aspartame on glucose homeostasis. Nutr Metab (Lond). 2012 Jun 14;9(1):58. doi: 10.1186/1743-7075-9-58.
PubMed 22697049Ornoy A, Ergaz Z. Alcohol abuse in pregnant women: effects on the fetus and newborn, mode of action and maternal treatment. Int J Environ Res Public Health. 2010 Feb;7(2):364-79. doi: 10.3390/ijerph7020364. Epub 2010 Jan 27.
PubMed 20616979Lass J, Kaar R, Jogi K, Varendi H, Metsvaht T, Lutsar I. Drug utilisation pattern and off-label use of medicines in Estonian neonatal units. Eur J Clin Pharmacol. 2011 Dec;67(12):1263-71. doi: 10.1007/s00228-011-1072-x. Epub 2011 Jun 11.
PubMed 21667125Fister P, Urh S, Karner A, Krzan M, Paro-Panjan D. The prevalence and pattern of pharmaceutical and excipient exposure in a neonatal unit in Slovenia. J Matern Fetal Neonatal Med. 2015;28(17):2053-61. doi: 10.3109/14767058.2014.976549. Epub 2015 Sep 4.
PubMed 25316561Valeur KS, Hertel SA, Lundstrom KE, Holst H. Safe excipient exposure in neonates and small children - protocol for the SEEN project. Dan Med J. 2017 Feb;64(2):A5324.
PubMed 28157063
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02545712
- Acronym / sponsor ID
- SEEN / BBH-KSV-01
- Conditions
- Excipient Exposure, Neonatal, Pediatric
- Keywords
- Ethanol, Propylene glycol, Benzyl alcohol, Acesulfam potassium, Aspartame, Glycerin, Sorbitol, Methyl-p-hydroxybenzoate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Jan 2016
- Primary completion
- Apr 2017 (estimated)
- First posted
- 10 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neonatal patients | – | Other: Exposure to ethanol, Other: Exposure to propylene glycol, Other: Exposure to benzyl alcohol, Other: Exposure to acesulfam potassium, Other: Exposure to aspartame, Other: Exposure to glycerol, Other: Exposure to sorbitol, Other: Exposure to methyl-p-hydroxybenzoate, Other: Exposure to propanyl-p-hydroxybenzoate, Other: Exposure to polysorbate-80Receiving 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. |
| Pediatric patients (28 days ≤ 5 years) | – | Other: Exposure to ethanol, Other: Exposure to propylene glycol, Other: Exposure to benzyl alcohol, Other: Exposure to acesulfam potassium, Other: Exposure to aspartame, Other: Exposure to glycerol, Other: Exposure to sorbitol, Other: Exposure to methyl-p-hydroxybenzoate, Other: Exposure to propanyl-p-hydroxybenzoate, Other: Exposure to polysorbate-80Receiving 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. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonatal patients and pediatric patients (≤ 5 years) who, at one point, have been/are being treated at the "Neonatalklinikken" (units 5021, 5023, 5024) or "BørneUngeklinikken" (units 5061, 5062, 5054, 4144) of Rigshospitalet, Denmark. To be included in the study, the patients must receive * 2 or more different drugs if < 28 days old * 3 or more different drugs if 28 day ≤ 5 years old
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- no up-dated weight is listed
- > 5 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to ethanolAlso: Ethyl achoholThe drug source(s) and amount administered daily are noted. | Other | Neonatal patients, Pediatric patients (28 days ≤ 5 years) |
| Exposure to propylene glycolThe drug source(s) and amount administered daily are noted. | Other | Neonatal patients, Pediatric patients (28 days ≤ 5 years) |
| Exposure to benzyl alcoholThe drug source(s) and amount administered daily are noted. | Other | Neonatal patients, Pediatric patients (28 days ≤ 5 years) |
| Exposure to acesulfam potassiumAlso: Acesulfame-KThe drug source(s) and amount administered daily are noted. | Other | Neonatal patients, Pediatric patients (28 days ≤ 5 years) |
| Exposure to aspartameThe drug source(s) and amount administered daily are noted. | Other | Neonatal patients, Pediatric patients (28 days ≤ 5 years) |
| Exposure to glycerolAlso: GlycerolThe drug source(s) and amount administered daily are noted. | Other | Neonatal patients, Pediatric patients (28 days ≤ 5 years) |
| Exposure to sorbitolThe drug source(s) and amount administered daily are noted. | Other | Neonatal patients, Pediatric patients (28 days ≤ 5 years) |
| Exposure to methyl-p-hydroxybenzoateAlso: including sodium-methyl-p-hydroxybenzoateThe drug source(s) and amount administered daily are noted. | Other | Neonatal patients, Pediatric patients (28 days ≤ 5 years) |
| Exposure to propanyl-p-hydroxybenzoateAlso: including sodium-propanyl-p-hydroxybenzoateThe drug source(s) and amount administered daily are noted. | Other | Neonatal patients, Pediatric patients (28 days ≤ 5 years) |
| Exposure to polysorbate-80The drug source(s) and amount administered daily are noted. | Other | Neonatal patients, Pediatric patients (28 days ≤ 5 years) |
Primary outcome
Blood alcohol content measured in per mille (grams of ethanol and propylene glycol pr. kilograms of blood) in the patient
Time frame: 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
Time frame: Single day
Concentration (mg/kg/day) of acesulfam potassium in the patient
Time frame: Single day
Concentration (mg/kg/day) of aspartame in the patient
Time frame: Single day
Concentration (mg/kg/day) of glycerin in the patient
Time frame: Single day
Concentration (mg/kg/day) 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/kg/day) of propyl-p-hydroxybenzoate in the patient
Time frame: Single day
Concentration (mg/kg/day) of polysorbate-80 in the patient
Time frame: Single day
16 secondary outcomes
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
Identification of number of patient exposed to ethanol levels above tolerance levels proposed by international medicines agencies like EMA and FDA
Time frame: Single day
Identification of number of patient exposed to propylene glycol levels above tolerance levels proposed by international medicines agencies like EMA and FDA
Time frame: Single day
Identification of number of patient exposed to benzyl alcohol levels above tolerance levels proposed by international medicines agencies like EMA and FDA
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Single day
Identification of number of patient exposed to acesulfame potassium levels above tolerance levels proposed by international medicines agencies like EMA and FDA
Time frame: Single day
Identification of number of patient exposed to aspartame levels above tolerance levels proposed by international medicines agencies like EMA and FDA
Time frame: Single day
Identification of number of patient exposed to glycerol levels above tolerance levels proposed by international medicines agencies like EMA and FDA
Time frame: Single day
Identification of number of patient exposed to sorbitol levels above tolerance levels proposed by international medicines agencies like EMA and FDA
Time frame: Single day
Identification of number of patient exposed to polysorbate-80 levels above tolerance levels proposed by international medicines agencies like EMA and FDA
Time frame: Single day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Background: PubMed 25854872Nellis G, Metsvaht T, Varendi H, Toompere K, Lass J, Mesek I, Nunn AJ, Turner MA, Lutsar I; ESNEE consortium. Potentially harmful excipients in neonatal medicines: a pan-European observational study. Arch Dis Child. 2015 Jul;100(7):694-9. doi: 10.1136/archdischild-2014-307793. Epub 2015 Apr 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristine Svinning Valeur, MS principal investigator
University Hospital Bispebjerg and Frederiksberg
Questions about this trial
What is this clinical trial studying?
An observational study of Excipient Exposure and Neonatal, run by Bispebjerg Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02545712, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.