Fever Pilot Trial
Research type
Research Study
Full title
A multi-centre randomised, parallel group pilot clinical trial investigating the feasibility of a definitive trial of a permissive temperature strategy in critically ill children with known or suspected infection.\n\n
IRAS ID
209931
Contact name
Mark J Peters
Contact email
Sponsor organisation
Intensive Care National Audit and Research Centre
Duration of Study in the UK
0 years, 4 months, 31 days
Research summary
There is strong evidence 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 guidance to recommend that drugs 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 very sick children admitted to a paediatric intensive care unit (PICU). \n\nThis application is for the Fever Pilot Trial. This is a small trial we intended to run to understand if it is possible to perform a larger trial to determine the effects of the current practice of strict control of fever with a more permissive approach. We will recruit 100 children admitted to PICU with a confirmed or suspected infection causing a fever, in four NHS hospitals over four months. Patients will be randomly allocated to receive either permissive approach to fever management (intervention) i.e. initiation of drugs/cooling methods to control temperature once the patients reaches a temperature of >39.5°C, or a restrictive approach (usual care) i.e. initiation of drugs/cooling methods to control temperature at ≥37.5°C. \n\nThis Fever Pilot Trial is the third of three related studies comprising the Fever Feasibility Study addressing the question: “can a larger clinical trial be done?”\n\nAs part of this Pilot Trial, we will conduct telephone interviews/questionnaires with parents/legal representatives of recruited participants, and focus groups/questionnaires with staff in the research sites. This is to further understand feasibility of the consent and trial procedures for the potential larger trial. \n
REC name
London - Hampstead Research Ethics Committee
REC reference
17/LO/1139
Date of REC Opinion
11 Aug 2017
REC opinion
Further Information Favourable Opinion