Extrait

Background and study aims A peripherally inserted central catheter (PICC) is a long, thin tube that goes into a vein in the upper arm. Babies in neonatal units often need to take medicines and fluids through PICCs for a long time. PICCs are inserted in order to avoid the need for repeated painful procedures and can stay in place for several weeks. However, very occasionally these PICCs can cause infections in the blood. There are currently two types of PICCs available. One type is coated with an antibiotic and an antifungal which might prevent infection by killing bacteria (AM-PICC), and the other type is not (a standard PICC). Although both are available, currently hospitals tend to use the standard PICC (S-PICC). We are currently investigating antimicrobial catheters in children, however, we also need to find out which catheter (PICC) is better in babies or if there is no difference between them. The study will help hospitals to decide which type of PICC to use for babies admitted to neonatal intensive care in the future. Who can participate? Babies who require the narrowest PICC. What does the study involve? Participating babies will be randomly allocated to be treated with either an AM-PICC or a S-PICC. The study will follow your baby using routine records and will use infection results from samples that need to be taken as part of your baby's routine clinical care. When your baby's PICC is removed, we will also test the tip for bacteria. Information will also be collected from the babies' hospital admission up till 6 months after they have entered the study. What are the possible benefits and risks of participating? Both PICCs are CE marked for use in babies which means they comply with EU legislation. Currently normal practise in hospitals is to use the standard PICCs; however, there is no evidence to support that these are better or worse than AM-PICC. For all PICCs there is a small risk that they may become infected and cause an infection in the blood. By using the antimicrobial PICCs this risk of infection may decrease. As the antimicrobial PICCs do contain a tiny amount of antibiotic and antifungal, there is a potential that instead of being beneficial they could be problematic. However, the main foreseeable disadvantage, that bacteria/fungi might become resistant to the antibiotic/antifungal, is very unlikely indeed to have any impact on a baby's care. Where is the study run from? The study will be run from 18 neonatal units in the UK. The lead centre will be Bradford Teaching Hospitals NHS Foundation Trust. The study will be co-ordinated through the Medicines for Children Clinical Trials Unit, University of Liverpool. When is the study starting and how long is it expected to run for? The study will run from December 2014 until August 2017. Who is funding the study? NIHR Health Technology Assessment Programme - HTA (UK). Who is the main contact? Professor Ruth Gilbert and Dr Sam Oddie [email protected]

Critère d'inclusion

• Infectious disease, preterm babies requiring a PICC

Liens

• ictrp
• isrctn