- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01196793
Hospital Admissions in Children Aged 3 Months to 5 Years Presenting With Fever to the Emergency Department
September 9, 2019 updated by: Imperial College Healthcare NHS Trust
Evaluation of Medical and Non-medical Factors Associated With Admission of Children Aged 3 Months to 5 Years Presenting to the Urban Paediatric Emergency Department With Febrile Illness in the United Kingdom and in Switzerland
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.
Study Overview
Status
Completed
Conditions
Detailed Description
A significant number of children 0 to 5 years of age are seen in paediatric Accident & Emergency departments (A&E) with feverish illness.
Most of these patients could safely be managed in a primary care setting, particularly with guidelines in place on how to optimally assess these children.
Some patients, however, will require admission, either because of a potentially serious underlying disease or because of other factors, for example parental concern or difficulties in communication because of language barriers.
An increase in the number of children attending A&E departments with feverish illness as well as a rise in the volume of admissions has been noted over time.
To enable an appropriate adaptation of acute medical services for children an in depth understanding of the assessment and admission processes is crucial.
Study Type
Observational
Enrollment (Actual)
108
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zurich, Switzerland, 8032
- University Children's Hospital
-
-
-
-
-
London, United Kingdom, W2 1NY
- St Mary's Hospital, Imperial NHS Hospitals Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Children aged 3 months to 5 years presenting to an urban paediatric emergency department with fever
Description
Inclusion Criteria:
- Child aged 3months to 5years
- Temperature above or equal to 38°C measured by any method or reported hot by parents
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
febrile children, age 3 m to 5 y
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Admission to Hospital Due to Parental High Levels of Worry
Time Frame: 7-10 days
|
Interview with the patient family to evaluation of the reasons for admission to emergency department
|
7-10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hermione Lyall, MD, Imperial College Healthcare NHS Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2012
Primary Completion (Actual)
July 3, 2014
Study Completion (Actual)
July 3, 2014
Study Registration Dates
First Submitted
September 6, 2010
First Submitted That Met QC Criteria
September 7, 2010
First Posted (Estimate)
September 8, 2010
Study Record Updates
Last Update Posted (Actual)
September 17, 2019
Last Update Submitted That Met QC Criteria
September 9, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMH 24062010 V1 4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fever
-
Centre Hospitalier Annecy GenevoisNot yet recruitingEmergency Call | Fever; Pediatric Fever Management; Parental AnxietyFrance
-
Karolinska InstitutetCompletedCrimean Congo Hemorrhagic FeverSweden
-
Chengdu Jinjiang Maternity and Child Health HospitalNot yet recruiting
-
Meir Medical CenterCompleted
-
Sanofi Pasteur, a Sanofi CompanyCompletedYellow Fever | Dengue | Dengue Fever | Dengue Hemorrhagic FeverUnited States
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Liverpool School of Tropical MedicineMedical Research Council; MEDEX; Mologic LtdRecruitingCrimean-Congo Haemorrhagic FeverTurkey (Türkiye)
-
Liverpool School of Tropical MedicineNot yet recruitingCrimean-Congo Hemorrhagic Fever
-
The Scientific and Technological Research Council...MonitorCROCompleted
-
Shaare Zedek Medical CenterCompleted