An evaluation of the feasibility of conducting a randomised clinical trial to evaluate the clinical and cost-effectiveness of a more permissive temperature threshold for antipyretic intervention in critically ill children with fever due to infection: the FEVER feasibility study
Professor Mark Peters
Associate Professor Padmanabhan Ramnarayan, Dr Kerry Woolfall, Dr Rachel Agbeko, Dr Shane Tibby, Miss Amy Jones, Mr Blaise Fenn, Mr Jason Watkins, Mr Paul Mouncey, Ms Clara Francis, Professor David Harrison, Professor Elizabeth Draper, Professor Kathryn Rowan, Professor Lyvonne Tume, Professor Nigel Klein
Great Ormond Street Hospital for Children NHS Trust, London
National Institute for Health Research (NIHR) – Health Technology Assessment (HTA) Programme (Project: 15/44/01)
A fever (high temperature) is a normal response by the body to infection. When a very sick child has a fever, the usual reaction from clinicians (doctors/nurses) is to cool down the child using medications or physical methods such as a cooling mat. The temperature at which clinicians usually start these treatments is about 37.5°C.
There is strong evidence, however, that fever is an important bodily response that may help a child to recover from infection. In 2013, the National Institute for Health and Care Excellence (NICE) updated their guidance to recommend that medications should not be used only for the purpose of reducing a child’s temperature. Most of the evidence for this recommendation came from research in non-critically ill children, therefore, it is unknown whether this recommendation should be applied to children, with fever due to infection, in a paediatric intensive care unit (PICU).
Prior to conducting a large, expensive, clinical trial to find out whether a higher temperature threshold to start treatments to cool down a child would be beneficial, we are conducting a three-phase study known as the Fever feasibility study to address the question “can a large clinical trial be done?”
Phase 1 (qualitative study) involves: interviews with parents/legal guardians whose child has been recently admitted to a hospital with a fever and a suspected infection. The views of these parents/guardians are important to help us find the best way to do the trial, including how we should explain the study to parents/guardians and how we should seek informed consent when a child is very ill.
Phase 2 (observational study) involves: collecting some information on children from 20 PICUs (e.g. whether they had fever due to infection and methods used to treat them). This phase will tell us important information, such as the design of the future trial and how many children would need to take part.
Phase 3 (pilot study): is a smaller version of the clinical trial we would like to conduct and will take place in four PICUs and will include 100 children. We will test the various trial processes and procedures to make sure they all work together in practice. This phase will tell us, practically, if the larger clinical trial can be done.