FeverNCT01196793
Hospital Admissions in Children Aged 3 Months to 5 Years Presenting With Fever to the Emergency Department
An observational study of Fever, run by Imperial College Healthcare NHS Trust at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Fever
- How many people
- 108 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Apr 2012to 3 Jul 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 3 months to 5 years presenting to an urban paediatric emergency department with fever
Who may be able to join
- Child aged 3months to 5years
- Temperature above or equal to 38°C measured by any method or reported hot by parents
Who cannot join
- none
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
St Mary's Hospital, Imperial NHS Hospitals Trust
London, W2 1NY
About this study
Official title: 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.
Read the 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.
- Conditions
- Fever
- Keywords
- Feverish illness in children
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| febrile children, age 3 m to 5 y | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study start30 Apr 2012
- Primary completion3 Jul 2014
- Study completion3 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hermione Lyall, MD, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196793
- Sponsor's protocol ID
- SMH 24062010 V1 4
- Status last verified
- Sep 2019
- First submitted
- 6 Sep 2010
- Last updated
- 17 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01196793
- Acronym / sponsor ID
- SMH 24062010 V1 4
- Conditions
- Fever
- Keywords
- Feverish illness in children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- 30 Apr 2012 (actual)
- Primary completion
- 3 Jul 2014 (actual)
- Study completion
- 3 Jul 2014 (actual)
- First posted
- 8 Sep 2010 (estimated)
- Results
- Posted 9 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| febrile children, age 3 m to 5 y | – | – |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 3 months to 5 years presenting to an urban paediatric emergency department with fever
Key inclusion criteria (2 listed)
- Child aged 3months to 5years
- Temperature above or equal to 38°C measured by any method or reported hot by parents
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Fever
Recruiting
Assessment of Communication Interventions on Vaccination Knowledge and Acceptance
Vaccination Knowledge and Acceptance, Informed Vaccine-decision Making
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hermione Lyall, MD principal investigator
Imperial College Healthcare NHS Trust
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever, run by Imperial College Healthcare NHS Trust at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Admission to Hospital Due to Parental High Levels of Worry (time frame: 7-10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.