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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
Sponsor:
Collaborators:
Institute of Child Health
Paediatric Intensive Care Audit Network (PICANet)
Great Ormond Street Hospital for Children NHS Foundation Trust
Information provided by (Responsible Party):
Intensive Care National Audit & Research Centre

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.

Condition or disease
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3960 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever




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


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All unplanned admissions to a PICU
Criteria

Inclusion Criteria:

unplanned PICU admission referral requiring PICU admission to a participating unit


Information from the National Library of Medicine

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


Locations
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United Kingdom
Intensive Care National Audit and Research Centre
London, United Kingdom, WC1V 6AZ
Sponsors and Collaborators
Intensive Care National Audit & Research Centre
Institute of Child Health
Paediatric Intensive Care Audit Network (PICANet)
Great Ormond Street Hospital for Children NHS Foundation Trust
Investigators
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Principal Investigator: Mark Peters, MBChB, PhD Institute of Child Health
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Intensive Care National Audit & Research Centre
ClinicalTrials.gov Identifier: NCT03028818    
Other Study ID Numbers: IRAS 209929
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fever
Body Temperature Changes