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Safe Excipient Exposure in Neonates and Small ChildreN (SEEN)

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ClinicalTrials.gov Identifier: NCT02545712
Recruitment Status : Unknown
Verified February 2017 by Kristine Svinning Valeur, Bispebjerg Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 10, 2015
Last Update Posted : February 7, 2017
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Kristine Svinning Valeur, Bispebjerg Hospital

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.

Condition or disease Intervention/treatment
Excipient Exposure Neonatal Pediatric 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

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

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Study Type : Observational
Actual Enrollment : 630 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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
Study Start Date : January 2016
Estimated Primary Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Group/Cohort Intervention/treatment
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 ethanol
The drug source(s) and amount administered daily are noted.
Other Name: Ethyl achohol

Other: Exposure to propylene glycol
The drug source(s) and amount administered daily are noted.

Other: Exposure to benzyl alcohol
The drug source(s) and amount administered daily are noted.

Other: Exposure to acesulfam potassium
The drug source(s) and amount administered daily are noted.
Other Name: Acesulfame-K

Other: Exposure to aspartame
The drug source(s) and amount administered daily are noted.

Other: Exposure to glycerol
The drug source(s) and amount administered daily are noted.
Other Name: Glycerol

Other: Exposure to sorbitol
The drug source(s) and amount administered daily are noted.

Other: Exposure to methyl-p-hydroxybenzoate
The drug source(s) and amount administered daily are noted.
Other Name: including sodium-methyl-p-hydroxybenzoate

Other: Exposure to propanyl-p-hydroxybenzoate
The drug source(s) and amount administered daily are noted.
Other Name: including sodium-propanyl-p-hydroxybenzoate

Other: Exposure to polysorbate-80
The drug source(s) and amount administered daily are noted.

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.
Other: Exposure to ethanol
The drug source(s) and amount administered daily are noted.
Other Name: Ethyl achohol

Other: Exposure to propylene glycol
The drug source(s) and amount administered daily are noted.

Other: Exposure to benzyl alcohol
The drug source(s) and amount administered daily are noted.

Other: Exposure to acesulfam potassium
The drug source(s) and amount administered daily are noted.
Other Name: Acesulfame-K

Other: Exposure to aspartame
The drug source(s) and amount administered daily are noted.

Other: Exposure to glycerol
The drug source(s) and amount administered daily are noted.
Other Name: Glycerol

Other: Exposure to sorbitol
The drug source(s) and amount administered daily are noted.

Other: Exposure to methyl-p-hydroxybenzoate
The drug source(s) and amount administered daily are noted.
Other Name: including sodium-methyl-p-hydroxybenzoate

Other: Exposure to propanyl-p-hydroxybenzoate
The drug source(s) and amount administered daily are noted.
Other Name: including sodium-propanyl-p-hydroxybenzoate

Other: Exposure to polysorbate-80
The drug source(s) and amount administered daily are noted.




Primary Outcome Measures :
  1. 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.

  2. Concentration (mg/kg/day) of benzyl alcohol in the patient [ Time Frame: Single day ]
  3. Concentration (mg/kg/day) of acesulfam potassium in the patient [ Time Frame: Single day ]
  4. Concentration (mg/kg/day) of aspartame in the patient [ Time Frame: Single day ]
  5. Concentration (mg/kg/day) of glycerin in the patient [ Time Frame: Single day ]
  6. Concentration (mg/kg/day) of sorbitol in the patient [ Time Frame: Single day ]
  7. Concentration (mg/l) of methyl-p-hydroxybenzoate in the patient [ Time Frame: Single day ]
  8. Concentration (mg/kg/day) of propyl-p-hydroxybenzoate in the patient [ Time Frame: Single day ]
  9. Concentration (mg/kg/day) of polysorbate-80 in the patient [ Time Frame: Single day ]

Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. 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 ]
    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.

  5. 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 ]
    Comparison of each patient daily exposure rate of ethanol to daily tolerance limit

  6. 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 ]
    Comparison of each patient daily exposure rate of proplyene glycol to daily tolerance limit

  7. 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 ]
    Comparison of each patient daily exposure rate of benzyl alcohol to daily tolerance limit

  8. 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 ]
    Comparison of each patient daily exposure rate of methyl-p-hydroxy-benzoate to daily tolerance limit

  9. 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 ]
    Comparison of each patient daily exposure rate of propyl-p-hydroxy-benzoate to daily tolerance limit

  10. 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 ]
    Comparison of each patient daily exposure rate of sodium-propyl-p-hydroxy-benzoate to daily tolerance limit

  11. 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 ]
    Comparison of each patient daily exposure rate of sodium-methyl-p-hydroxy-benzoate to daily tolerance limit

  12. 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 ]
    Comparison of each patient daily exposure rate of acesulfame potassium to daily tolerance limit

  13. 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 ]
    Comparison of each patient daily exposure rate of aspartame to daily tolerance limit

  14. 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 ]
    Comparison of each patient daily exposure rate of glycerol to daily tolerance limit

  15. 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 ]
    Comparison of each patient daily exposure rate of sorbitol to daily tolerance limit

  16. 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 ]
    Comparison of each patient daily exposure rate of polysorbate-80 to daily tolerance limit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545712


Sponsors and Collaborators
Bispebjerg Hospital
Rigshospitalet, Denmark
Investigators
Layout table for investigator information
Principal Investigator: Kristine Svinning Valeur, MS Bispebjerg Frederiksberg Hospital

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kristine Svinning Valeur, MS, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT02545712     History of Changes
Other Study ID Numbers: BBH-KSV-01
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Keywords provided by Kristine Svinning Valeur, Bispebjerg Hospital:
Ethanol
Propylene glycol
Benzyl alcohol
Acesulfam potassium
Aspartame
Glycerin
Sorbitol
Methyl-p-hydroxybenzoate
Propanyl-p-hydroxybenzoate
Patients
Additional relevant MeSH terms:
Layout table for MeSH terms
Ethanol
Benzyl Alcohol
Sorbitol
Glycerol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Cryoprotective Agents
Protective Agents
Cathartics
Gastrointestinal Agents
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents