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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

Tracking Information
First Submitted Date September 3, 2015
First Posted Date September 10, 2015
Last Update Posted Date February 7, 2017
Study Start Date January 2016
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 4, 2017)
  • 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 ]
Original Primary Outcome Measures
 (submitted: September 9, 2015)
  • Blood alcohol content measured in per mille (grams of ethanol and propylene glycol pr. kilograms of blood) in the neonatal 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/l) of benzyl alcohol in the neonatal patient [ Time Frame: Single day ]
  • Concentration (mg/l) of acesulfam potassium in the neonatal patient [ Time Frame: Single day ]
  • Concentration (mg/l) of aspartame in the neonatal patient [ Time Frame: Single day ]
  • Concentration (mg/l) of glycerin in the neonatal patient [ Time Frame: Single day ]
Change History Complete list of historical versions of study NCT02545712 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 4, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: September 9, 2015)
  • 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, acesulfam potassium, aspartame and glycerin) 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)) [ Time Frame: During the participants hospitalization, an expected average of 2 months ]
    The excipients (ethanol, propylene glycol, benzyl alcohol, acesulfam potassium, aspartame and glycerin) will be ranked according to which excipient is present (as an average) in the largest amount (mg/l) in the average patient.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safe Excipient Exposure in Neonates and Small ChildreN
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
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
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Excipient Exposure
  • Neonatal
  • Pediatric
Intervention
  • 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.
Study Groups/Cohorts
  • 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.
    Interventions:
    • 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.
    Interventions:
    • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: February 4, 2017)
630
Original Estimated Enrollment
 (submitted: September 9, 2015)
200
Study Completion Date Not Provided
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 5 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02545712
Other Study ID Numbers BBH-KSV-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kristine Svinning Valeur, Bispebjerg Hospital
Study Sponsor Bispebjerg Hospital
Collaborators Rigshospitalet, Denmark
Investigators
Principal Investigator: Kristine Svinning Valeur, MS Bispebjerg Frederiksberg Hospital
PRS Account Bispebjerg Hospital
Verification Date February 2017