European Study of Neonatal Excipient Exposure (ESNEE): Study of excipient kinetics in neonates

Description: ESNEE project aimed to provide an integrated assessment of exposure among neonates in Europe to potentially toxic excipients.
Main objectives:

• to undertake a comprehensive European questionnaire and point prevalence study of excipient exposure in neonates; 
• to conduct a systematic review 
• to develop EK models for selected excipients Observational case-controlled study. 

Primary outcome measures: To develop pilot excipient kinetic models to indicate how much of each selected excipient is in the bloodstream of babies who have been given medicines containing those excipients.

Funding:

• Medical Research Council (MRC) (UK); 
• Estonian Science Foundation (EE); 
• Agence Nationale de la Recherche (FR)

EUDRA-CT: No

Link: http://www.infantjournal.co.uk/pdf/inf_042_ien.pdf

Partners:

Project's status: Finished