Authors' objectives: A recent research study conducted in Africa found that restricting the amount of fluid given to children with a severe infection resulted in fewer deaths. Currently, in the UK, children with a severe infection tend to be treated with liberal amounts of fluid; however, there have been very few research studies to support this approach. Although the results of the African study may not apply to children in the UK, because of differences in delivery of healthcare services, child nutrition and causes of infection, the study has highlighted the need for more research in this area. The Fluids in Shock (FiSh) trial aims to investigate whether giving less fluid is more beneficial to children with a severe infection than the (higher) amounts of fluid currently recommended in the UK. As large clinical trials are expensive to conduct, it is important to demonstrate that a trial can be done and that the different components of the trial can all work together. Before embarking on the full FiSh trial, we will conduct an 18-month combined feasibility and pilot study to explore and test important parameters needed to inform the design and successful conduct of the FiSh trial. A feasibility study is a piece of research done before the main trial to answer the question can this trial be done? and is used to estimate important factors such as willingness of patients to take part. A pilot study is a miniature version of the full trial and is done to check that the different components, such as recruiting patients, randomisation, treatment and follow-up all run smoothly. During the feasibility study, interviews will be conducted with parents/guardians to explore important patient-centred outcome measures for the trial and the acceptability and potential barriers to using deferred consent. Deferred consent is an approach which has been successfully used in previous emergency care studies, in which a child is included in the study without prior consent from their parents/guardians. The reason for considering this approach for FiSh is that discussing a research study with parents/guardians when their child is in need of urgent treatment may be inappropriate and may impose an additional burden on parents/guardians in an already very stressful situation. A process for deferred consent will be established with parents/guardians. Following the feasibility study, a pilot study will be conducted in 12 hospitals around the UK and will recruit 108 children. During the pilot study, we will test the deferred consent process and its acceptability to the parents/guardians of children taking part, including the information sheets that will be provided. We will also test screening, recruitment, delivery and adherence to the intervention and trial procedures. Data will be collected on the outcomes identified as important by parents/guardians and this data will be used to inform selection of the final patient-centred outcome measure to be used in the FiSh trial. This will also inform the number of children that will need to take part in the full FiSh trial and the data that should be collected. Following completion of the feasibility and pilot studies, we will report a clear recommendation, or not, for continuation to the full FiSh trial.

Project Status: Completed

URL for project: http://www.nets.nihr.ac.uk/projects/hta/1304105

Year Published: 2018

URL for published report: http://www.nets.nihr.ac.uk/projects/hta/1304105

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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