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

iverpool Women's NHS Foundation Trust (UK)0 个研究点目标入组 1,300 人开始时间: 2012年5月28日最近更新: 2018年2月26日

试验速览

•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.

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

发起方

iverpool Women's NHS Foundation Trust (UK)