NCT03028818

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,960

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

January 13, 2017

Last Update Submit

January 19, 2017

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All unplanned admissions to a PICU

You may qualify if:

  • unplanned PICU admission referral requiring PICU admission to a participating unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care National Audit and Research Centre

London, WC1V 6AZ, United Kingdom

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mark Peters, MBChB, PhD

    Institute of Child Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2017

First Posted

January 23, 2017

Study Start

February 1, 2017

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

January 23, 2017

Record last verified: 2017-01

Locations