Fever Observational Study
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|ClinicalTrials.gov Identifier: NCT03028818|
Recruitment Status : Unknown
Verified January 2017 by Intensive Care National Audit & Research Centre.
Recruitment status was: Enrolling by invitation
First Posted : January 23, 2017
Last Update Posted : January 23, 2017
|Condition or disease|
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 [Patient Registry]|
|Estimated Enrollment :||3960 participants|
|Target Follow-Up Duration:||30 Days|
|Official Title:||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|
|Estimated Study Start Date :||February 2017|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||August 2017|
- To determine the number of patients who meet the eligibility criteria for a proposed definitive trial. [ Time Frame: Baseline ]
- Temperature thresholds currently employed in at least 20 paediatric intensive care units (PICU) in the UK [ Time Frame: First 5 calender days ]
- Length of ventilation - mean (standard deviation) [ Time Frame: Through study completion, an average of 2 days ]
- Length of PICU stay - mean (standard deviation) [ Time Frame: Through study completion, an average of 2 days ]
- PICU mortality - number (percentage) [ Time Frame: Through study completion, an average of 2 days ]
- Hospital mortality - number (percentage) [ Time Frame: Through study completion, an average of 2 days ]
- Days of organ specific support - mean (standard deviation) [ Time Frame: Through study completion, an average of 2 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028818
|Intensive Care National Audit and Research Centre|
|London, United Kingdom, WC1V 6AZ|
|Principal Investigator:||Mark Peters, MBChB, PhD||Institute of Child Health|