PREVenting infection using Antibiotic Impregnated Long lines (PREVAIL)

Many babies admitted to intensive care need fluids and medicines given to them through their veins These are often given through a peripherally inserted central catheter (PICC) A PICC is a very narrow tube placed through the skin of the arm or leg and into a central vein These lines can stay in place for several weeks, avoiding the need for repeated procedures The disadvantage of PICC is that infections can develop due to bacteria sticking onto the inside or outside of the tube These infections can spread making the baby very ill Affected babies need antimicrobial treatment and often have to stay longer in intensive care Although infections caused by PICC are uncommon, the long-term consequences of these infections in small babies can be very serious, including damage to the brain and even resulting in death In adults, it has been shown that when the PICC is coated with an antimicrobial that kills bacteria, the risk of infection can be reduced A trial is currently investigating antimicrobial lines in children, but no research has been done in preterm new-born babies to find whether antimicrobial PICC are better at preventing infection than the standard PICC that are currently used everywhere in the UK There are important differences between children and preterm babies that mean that antimicrobial PICC might work differently First, preterm babies' veins are much smaller and the PICC is narrower Second, PICC are often kept in place for much longer (the risk of infection increases over the time a PICC is in place) Third, infections happen more often in preterm babies, as their immune systems and immature skin are not as good at preventing infection Fourth, the combination of antimicrobials used is different to those tested in studies in children and adults Finally, the consequences of infection in preterm babies are different and more serious than in older children The antimicrobial PICC in this study has been licensed for use in babies and, apart from brown coloured tubing, looks exactly the same as PICC used throughout the UK The antimicrobials are impregnated into the plastic, resulting in high levels of antimicrobials very close to the line, but very low levels in blood The antimicrobial PICC could reduce serious illness and deaths in preterm babies Although antimicrobial PICC are more expensive than standard PICC, the NHS may actually save money by preventing infection and all of its related problems We will also assess whether antimicrobial PICC cause growth of resistant organisms The only way to accurately test the antimicrobial PICC is to run a comparison with standard PICC In such a trial, a baby will receive one or other PICC by chance allocation, as though by tossing a coin (known as a randomised controlled trial) 18 neonatal units will take part and 858 babies will participate over 2 years If a baby in one of these units needs a PICC, they will have a 50-50 chance of being given a standard PICC or an antimicrobial PICC The study will follow up babies using routine records and will use infection results from samples that need to be taken as part of the baby's routine clinical care No additional samples will be taken The study will be discussed with the parent/legal guardian and the baby will only join if parents agree to participate before the PICC is placed This trial will help us find out whether antimicrobial PICC can help avoid the serious effects of infection in vulnerable babies