Extrait

Background and study aims Some children who are unwell can have damage caused to their kidneys either by the illness itself, or the drugs used to treat the illness. Currently we measure a substance called creatinine in blood tests to check how well the kidneys are working. However, creatinine is slow to show any damage to the kidney, so we may not find out that damage has occurred until it is too late to reverse it. Also doing this test means having to take a blood sample. A number of substances, which we call biomarkers, can be measured in the urine. We think that some of these biomarkers might be useful at telling us how well a child’s kidneys are working, and whether any damage is occurring. This study will help us to develop urine biomarker tests that will one day be part of our normal clinical practice, and will improve our care of future children. Who can participate? We are asking healthy children aged 0 to 16 years to consider taking part in this study. What does the study involve? The study has two parts. Participants can do just the first part, or they can do both parts. Children, and their parents, will be approached for recruitment in a number of different settings: in schools, nurseries, at Alder Hey Children’s Hospital (AHCH) in Liverpool, and children of University of Liverpool or AHCH employees. Part 1 A single urine sample will be collected from the child. Ideally the urine sample will be collected by asking the child to pass urine into a sterile container. Part 2 This part will take longer, and will need the child to do four more urine samples at home. They will need to collect: A morning urine sample once a week for the next three weeks. One bedtime urine sample the evening before one of the morning urine samples. The morning samples should be done when the child gets up, and the evening sample just before going to bed. The evening sample will need to be kept in the fridge overnight. The child & their parents will be given sample pots to take home. The sample will need to be brought on the morning of collection to the research team at the site of recruitment. We will store the urine samples in a freezer, and test for different biomarkers at different times. We will keep the sample until it is used up. What are the possible benefits and risks of participating? We do not anticipate any problems. We will choose an appropriate urine collection method for each child. There are no immediate benefits. If we find the urine biomarkers are too high in a child’s urine sample we will check this again in our laboratory. If it is still high we will ask the child’s general practitioner (GP) to see them. Where is the study run from? This research is being run by the University of Liverpool and Alder Hey Children’s NHS Foundation Trust. When is study starting and how long is it expected to run for? The study started in March 2012, and is expected to run until October 2014 Who is funding the study? The study is funded by the Medical Research Council. Who is the main contact? Dr Steve McWilliam [email protected]

Critère d'inclusion

• Kidney function

Liens

• isrctn
• ictrp