Antiseptic Randomised Controlled Trial for Insertion of Catheters v1.0
Research type
Research Study
Full title
The efficacy and safety of two topical antiseptic solutions for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: a feasibility study
IRAS ID
163868
Contact name
Paul Clarke
Contact email
Sponsor organisation
Norfolk and Norwich University Hospitals NHS Trust
Eudract number
2015-000874-36
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
During intensive care, many premature babies need to have a special catheter (line) put into one of their larger (central) veins to give special liquid nutrition safely to help them grow. 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 important to prevent infection. Some antiseptics may be better at preventing catheter infection as well as 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. We need to find out which antiseptics are best for premature babies. In the future we will do a large study to compare two antiseptics commonly used to clean the skin in premature babies: we will test 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. First however we must do a small 'feasibility' study in order to gather vital information for designing the large study properly. Parents of babies needing a catheter for routine clinical care will be asked if they would like include their babies in the study. Babies in the study will have their skin cleaned with one or other of the two antiseptics before the catheter is inserted. We will test the skin and also the catheters to see if they end up coated with (colonised by) bacteria by the time of catheter removal, because catheter colonisation is a major risk factor for infection. At the end of this study, we will know how to design the large trial and how many babies will be needed for it.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
15/EE/0345
Date of REC Opinion
30 Oct 2015
REC opinion
Further Information Favourable Opinion