Extrait

Background and study aims Medicines contain active pharmaceutical ingredients along with a range of other chemicals, collectively known as excipients. These excipients are required to overcome the chemical, physical and microbiological issues that occur when developing formulations that are of good quality to be used in clinical practice. Extensive work is done by pharmaceutical companies to ensure that excipients are safe, which requires knowledge about exposure and outcomes. Premature babies are a vulnerable group as they are not yet suited to life outside of the uterus and can become seriously ill as they adapt to birth, therefore they are often given multiple medications to help them. This may also be the case for full-term babies who are seriously unwell, for example with infections. Nobody has measured the levels of excipients used in medicines for babies and although we are happy with those currently used in clinical practice, it would help to know more about how the body handles the excipients currently used. It would also help pharmacists when developing new medicines for use in babies to ensure that only chemicals that are necessary are included in the formulations. The main aim of the study is to measure the concentration of selected excipient in blood samples taken from newborn babies. Who can participate? Treatment, or likely treatment, of neonates with a drug prescribed containing any of the following excipients; Propylene Glycol, Ethanol and metabolites (Fatty acid ethyl esters are no-oxidative ehtanol metabolities), Propylhydroxybenzoate and other parabens, sodium benzoate/benzoic acid/benzyl alcohol, Polysorbate 80, Sorbitol. Each neonatal unit will develop a list of medicines containing the excipient which will trigger eligibility to the study. What does the study involve? This is an observational study of routine clinical practice in which clinical data will be supplemented by information from blood samples taken opportunistically or during specific sampling periods. What are the possible benefits and risks of participating? There is no expected direct benefit to participants and no risks. Where is the study run from? Liverpool Women's NHS Foundation Trust When is the study starting and how long is it expected to run for? October 2011 to December 2012 Who is funding the study? Medical Research Council (MRC), UK Who is the main contact? Ms Susan Graham [email protected]

Critère d'inclusion

• Medicines for neonates

Liens

• isrctn
• ictrp