Safe Excipient Exposure in Neonates and Small ChildreN

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.

Conditions

• Excipient Exposure
• Neonatal
• Pediatric

Interventions

OTHER

Exposure to ethanol

The drug source(s) and amount administered daily are noted.

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

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

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

Exposure to propanyl-p-hydroxybenzoate

The drug source(s) and amount administered daily are noted.

OTHER

Exposure to polysorbate-80

The drug source(s) and amount administered daily are noted.

Sponsors & Collaborators

• Rigshospitalet, Denmark

  collaborator OTHER

• Bispebjerg Hospital

  lead OTHER

Principal Investigators

• Kristine Svinning Valeur, MS · University Hospital Bispebjerg and Frederiksberg

Eligibility

Max Age

5 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2017-04-30