NCT02545712 (SEEN) is a clinical trial of Exposure to ethanol in Excipient Exposure, sponsored by Bispebjerg Hospital.

Who is sponsoring NCT02545712?

NCT02545712 is sponsored by Bispebjerg Hospital.

What drugs are being tested in NCT02545712?

Interventions in NCT02545712: Exposure to ethanol, Exposure to propylene glycol, Exposure to benzyl alcohol, Exposure to acesulfam potassium, Exposure to aspartame, Exposure to glycerol, Exposure to sorbitol, Exposure to methyl-p-hydroxybenzoate, Exposure to propanyl-p-hydroxybenzoate, Exposure to polysorbate-80.

What condition does NCT02545712 study?

NCT02545712 studies Excipient Exposure, Neonatal, Pediatric.

Is NCT02545712 still recruiting?

NCT02545712 is currently status unknown. Last updated 4 February 2017.

Last reviewed 2017-02-04 · How we verify

NCT02545712: SEEN

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Last updated 4 February 2017

What this trial tests

trial testing Exposure to ethanol in Excipient Exposure in 630 participants. Status unknown.

Timeline

1 January 2016

Primary endpoint
1 April 2017

Quick facts

Lead sponsor	Bispebjerg Hospital
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	630
Start date	1 January 2016
Primary completion	1 April 2017

Drugs / interventions tested

Exposure to ethanol
Exposure to propylene glycol
Exposure to benzyl alcohol
Exposure to acesulfam potassium
Exposure to aspartame
Exposure to glycerol
Exposure to sorbitol
Exposure to methyl-p-hydroxybenzoate
Exposure to propanyl-p-hydroxybenzoate
Exposure to polysorbate-80

Conditions studied

Excipient Exposure — all drugs for Excipient Exposure →
Neonatal — all drugs for Neonatal →
Pediatric — all drugs for Pediatric →

Sponsor

Bispebjerg Hospital

Who can join

Under 5, any sex, with Excipient Exposure or Neonatal. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Excipients in Neonatal Medicinal Products: Never Prescribed, Commonly Administered.
Valeur KS, Holst H, Allegaert K. · · 2018 · cited 32× · PMID 30174435 · DOI 10.1007/s40290-018-0243-9
Safe excipient exposure in neonates and small children - protocol for the SEEN project.
Valeur KS, Hertel SA, Lundstrøm KE, Holst H. · · 2017 · cited 8× · PMID 28157063

Verify or expand the search:

Other Bispebjerg Hospital trials

Trials by the same sponsor.

NCT06872060 — The Effects of Glucagon on Renal Regional Blood Flow in Humans Measured by Magnetic Resonance. · NA · not yet recruiting
NCT07373587 — Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy · NA · not yet recruiting
NCT07123558 — Anal Cancer Prevention in High-Risk Categories of Men Who Have Sex With Men · NA · not yet recruiting
NCT07124338 — Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy, a Feasibili · NA · active not recruiting
NCT07096648 — Alert Burden When Monitoring Patients at Home · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02545712 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bispebjerg Hospital
Last refreshed: 4 February 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02545712.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing