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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

Tracking Information
First Submitted Date January 13, 2017
First Posted Date January 23, 2017
Last Update Posted Date January 23, 2017
Estimated Study Start Date February 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 19, 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 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fever Observational Study
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
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 30 Days
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All unplanned admissions to a PICU
Condition Fever
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 19, 2017)
3960
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

unplanned PICU admission referral requiring PICU admission to a participating unit

Sex/Gender
Sexes Eligible for Study: All
Ages up to 15 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03028818
Other Study ID Numbers IRAS 209929
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Intensive Care National Audit & Research Centre
Original Responsible Party Same as current
Current Study Sponsor Intensive Care National Audit & Research Centre
Original Study Sponsor Same as current
Collaborators
  • Institute of Child Health
  • Paediatric Intensive Care Audit Network (PICANet)
  • Great Ormond Street Hospital for Children NHS Foundation Trust
Investigators
Principal Investigator: Mark Peters, MBChB, PhD Institute of Child Health
PRS Account Intensive Care National Audit & Research Centre
Verification Date January 2017