Extrait

Background and study aims When in intensive care, many premature babies need to have a special catheter (thin tube) put into one of their larger (central) veins to give liquid nutrition safely to help them grow (percutaneous central venous catheter, PCVC). These catheters are vital, but can sometimes become infected. Catheter infection is a dangerous complication. Cleaning a baby's skin with antiseptic before inserting a catheter is one important way to prevent catheter infection. Some antiseptics may be better at preventing catheter infection than others, as well as being safer to use on the thin vulnerable skin of premature babies. Doctors don't yet know which antiseptics are safest and best to use in premature babies. It is therefore important to find out which antiseptics are best for use in premature babies. Chorhexidine and alcohol and two different antiseptics that are commonly used in neonatal units to clean the skin of babies before catheters are inserted. Sometimes these particular antiseptics are used individually and sometimes they are used in combination. In the future a large study will be conducted to compare two forms of these antiseptics for cleaning the skin in premature babies, to find out if chlorhexidine on its own is just as good at cleaning a baby's skin as chlorhexidine mixed with alcohol. The findings will guide doctors in deciding which antiseptic to choose for skin preparation in premature babies and will show if alcohol is important to use along with chlorhexidine, or whether alcohol can be avoided. The aim of this study is to investigate whether a large scale study looking at the effectiveness and safety of these antiseptic solutions for cleaning skin before PCVC insertion is feasible. Who can participate? Premature babies born at least six weeks early who need a PCVC placed as part of their routine care. What does the study involve? Babies in the study are randomly allocated to one of two groups, who each have the skin cleaned with one of two antiseptics just before the catheter is inserted and again just before the catheter gets removed. Three quarters of the babies are randomly allocated to receive an chlorhexidine mixed with alcohol (70% isopropyl alcohol-based 2% chlorhexidine gluconate) and one quarter to receive chlorhexidine antiseptic (2% chlorhexidine gluconate). The skin and the catheters are tested after removal to see if they ended up coated with (colonised by) bacteria by the time of catheter removal, because catheter colonisation is a known major risk factor for infection. The number of babies recruited to the study and who stayed in until the end of the study are also recorded to gather information about how many babies are needed to conduct a larger study. What are the possible benefits and risks of participating? It is not known whether there will be any benefits of taking part in this study, however if the antiseptic the participants receive is more effective than the one normally used for central venous catheter insertion, then they may benefit from a decreased risk of catheter infection. Both antiseptic solutions chosen for use in this study are already commonly used in premature babies in Europe and America. Skin reactions such as redness and chemical burns have occasionally been reported with both of these antiseptics. The risk of skin reactions is increased when excess antiseptic solution is used or when it is in prolonged contact with the skin in very premature babies. Where is the study run from? Norfolk and Norwich University Hospital, Norwich (lead centre) and Medway Maritime Hospital, Gillingham (UK) When is the study starting and how long is it expected to run for? May 2015 to September 2018 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? 1. Dr Paul Clarke (scientific) [email protected] 2. Mrs Tracy Oliver (public) [email protected]

Critère d'inclusion

• Specialty: Children, Primary sub-specialty: Neonatal

Liens

• isrctn