Fever Observational Study

An Observational Study of the Epidemiology of Fever Due to Infection in Critically Ill Children Following an Unplanned Admission to a Paediatric Intensive Care Unit

To inform the feasibility of conducting a study to test different temperature thresholds at which clinicians deliver interventions to reduce fever (i.e. antipyretic interventions) in critically ill children with fever due to infection.

Study Overview

• Status: Unknown
• Conditions: Fever

Detailed Description

Fever (high temperature) is a normal bodily response to an infection, which has shown to have a beneficial effect in humans with chickenpox, malaria and rhinovirus infections. In children it has been recommended by the National Institute for Health and Care Excellence not to cool down the child using drugs or physical methods such as a cooling mat, with the sole aim to reducing the child's temperature. However, this recommendation is not aimed at the management of critically ill children, to which there is uncertainty around use of cooling interventions when considering the advantages of a fever in defending the body against viruses and bacteria during critical illness, and weighing that up with the possible negative physiological consequences of a high fever e.g. increased metabolic rate.

Observational studies show that the treatment of fever in critically ill children is inconsistent. There is a lack of robust data to guide antipyretic intervention, with clinicians usually starting fever management at around 37.5°C. Evidence is emerging that fever may be beneficial in critically ill adults. Due to the physiological differences between adults and children there is an important need to evaluate whether a different approach to fever management in critically ill children may also be beneficial.

Prior to conducting a large, expensive, randomised clinical trial (RCT) to evaluate whether a higher temperature threshold in starting treatments to cool down the child would be beneficial, we are conducting three studies to know if it is possible for us to test key outcome measures as a result of testing different temperatures thresholds for antipyretic management.

The Fever Observational Study is one of these studies, with the aim of identifying: the potential population that would be eligible for the proposed definitive trial, current temperature threshold(s) for fever management, and to describe the characteristics of outcome measures with the intention of deciding on a main measure to see which treatment method was more successful.

• Study Type: Observational
• Enrollment (Anticipated): 3960

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1V 6AZ
    • Intensive Care National Audit and Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All unplanned admissions to a PICU

Description

Inclusion Criteria:

unplanned PICU admission referral requiring PICU admission to a participating unit

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the number of patients who meet the eligibility criteria for a proposed definitive trial.	Baseline
Temperature thresholds currently employed in at least 20 paediatric intensive care units (PICU) in the UK	First 5 calender days
Length of ventilation - mean (standard deviation)	Through study completion, an average of 2 days
Length of PICU stay - mean (standard deviation)	Through study completion, an average of 2 days
PICU mortality - number (percentage)	Through study completion, an average of 2 days
Hospital mortality - number (percentage)	Through study completion, an average of 2 days
Days of organ specific support - mean (standard deviation)	Through study completion, an average of 2 days

Collaborators and Investigators

• Sponsor: Intensive Care National Audit & Research Centre
• Collaborators: Institute of Child Health; Great Ormond Street Hospital for Children NHS Foundation Trust; Paediatric Intensive Care Audit Network (PICANet)
• Investigators: Principal Investigator: Mark Peters, MBChB, PhD, Institute of Child Health

Publications and helpful links

General Publications

• Deja E, Peters MJ, Khan I, Mouncey PR, Agbeko R, Fenn B, Watkins J, Ramnarayan P, Tibby SM, Thorburn K, Tume LN, Rowan KM, Woolfall K. Establishing and augmenting views on the acceptability of a paediatric critical care randomised controlled trial (the FEVER trial): a mixed methods study. BMJ Open. 2021 Mar 10;11(3):e041952. doi: 10.1136/bmjopen-2020-041952.
• Peters MJ, Khan I, Woolfall K, Deja E, Mouncey PR, Wulff J, Mason A, Agbeko R, Draper ES, Fenn B, Gould DW, Koelewyn A, Klein N, Mackerness C, Martin S, O'Neill L, Ramnarayan P, Tibby S, Tume L, Watkins J, Thorburn K, Wellman P, Harrison DA, Rowan KM. Different temperature thresholds for antipyretic intervention in critically ill children with fever due to infection: the FEVER feasibility RCT. Health Technol Assess. 2019 Feb;23(5):1-148. doi: 10.3310/hta23050.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2017
• Primary Completion (ANTICIPATED): July 1, 2017
• Study Completion (ANTICIPATED): August 1, 2017

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (ESTIMATE): January 23, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): January 23, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Fever
• Other Study ID Numbers: IRAS 209929

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No