NCT01196793

Brief Summary

This study primarily aims to describe factors associated with hospitalisation of children aged 3 months to 5 years presenting with fever to an urban paediatric A\&E departments by describing and analysing characteristics both of those patients admitted to hospital and those managed in the community. To complement this, information on the short-term healthcare utilization by families attending the emergency department because of feverish illness will be collected. The study will be carried out in one participating centre in Switzerland and the United Kingdom, respectively, to enable a head to head comparison of the assessment and admission practices in two European countries. The resulting data will be used as the basis for further research in this area and will provide information on how to optimally structure service provision in acute febrile childhood illness.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2012

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed
1.6 years until next milestone

Study Start

First participant enrolled

April 30, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2014

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

September 9, 2019

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

2.2 years

First QC Date

September 6, 2010

Results QC Date

July 24, 2019

Last Update Submit

September 9, 2019

Conditions

Keywords

Feverish illness in children

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Admission to Hospital Due to Parental High Levels of Worry

    Interview with the patient family to evaluation of the reasons for admission to emergency department

    7-10 days

Study Arms (1)

febrile children, age 3 m to 5 y

Eligibility Criteria

Age3 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children aged 3 months to 5 years presenting to an urban paediatric emergency department with fever

You may qualify if:

  • Child aged 3months to 5years
  • Temperature above or equal to 38°C measured by any method or reported hot by parents

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Children's Hospital

Zurich, 8032, Switzerland

Location

St Mary's Hospital, Imperial NHS Hospitals Trust

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr Hermione Lyall
Organization
Imperial College London NHS Trust

Study Officials

  • Hermione Lyall, MD

    Imperial College Healthcare NHS Trust

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2010

First Posted

September 8, 2010

Study Start

April 30, 2012

Primary Completion

July 3, 2014

Study Completion

July 3, 2014

Last Updated

September 17, 2019

Results First Posted

September 9, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations