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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03028818
Enrollment
3960
Registered
2017-01-23
Start date
2017-02-28
Completion date
2017-08-31
Last updated
2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever

Brief summary

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.

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.

Interventions

None listed

Sponsors

Institute of Child Health
CollaboratorOTHER
Paediatric Intensive Care Audit Network (PICANet)
CollaboratorOTHER
Great Ormond Street Hospital for Children NHS Foundation Trust
CollaboratorOTHER
Intensive Care National Audit & Research Centre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 15 Years
Healthy volunteers
No

Inclusion criteria

unplanned PICU admission referral requiring PICU admission to a participating unit

Design outcomes

Primary

MeasureTime frame
PICU mortality - number (percentage)Through study completion, an average of 2 days
Hospital mortality - number (percentage)Through study completion, an average of 2 days
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 UKFirst 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
Days of organ specific support - mean (standard deviation)Through study completion, an average of 2 days

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026