European study of neonatal excipient exposure: study of excipient kinetics in neonates

Not Applicable

Completed

• Conditions: Medicines for neonates; Not Applicable

• Registration Number: ISRCTN31837223
• Lead Sponsor: iverpool Women's NHS Foundation Trust (UK)

Brief Summary

2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27212021

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-28
• Study Completion: 2012-12-31
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1300

Inclusion Criteria

Treatment, or likely treatment, of neonates with a drug prescribed containing any of the following excipients:
1. Propylene glycol
2. Ethanol and metabolites [Fatty acid ethyl esters (FAEEs) are nonoxidative ethanol metabolites]
3. Propylhydroxybenzoate and other parabens
4. Sodium benzoate/benzoic acid/ benzyl alcohol
5. Polysorbate 80
6. Sorbitol
Each neonatal unit will develop a list of medicines containing the excipient which will trigger eligibility to the study.

An example list of the drugs prescribed in the lead UK neonatal unit which contain the excipients can be provided on request to the study coordinator.

Exclusion Criteria

1. Babies whose mothers refuse to give consent
2. Babies whose mothers are deemed too poorly or not competent to give valid consent

Study & Design

• Study Type: Observational
• Study Design: Not specified