Hospital Admissions in Children Aged 3 Months to 5 Years Presenting With Fever to the Emergency Department
Recruitment status was Not yet recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | September 6, 2010 | ||||
| Last Updated Date | September 7, 2010 | ||||
| Start Date ICMJE | November 2010 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Hospital admission [ Time Frame: 7-10 days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01196793 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Hospital Admissions in Children Aged 3 Months to 5 Years Presenting With Fever to the Emergency Department | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Children aged 3 months to 5 years presenting to an urban paediatric emergency department with fever |
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| Condition ICMJE | Fever | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | febrile children, age 3 m to 5 y | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 5600 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 3 Months to 5 Years | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Switzerland, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01196793 | ||||
| Other Study ID Numbers ICMJE | SMH 24062010 V1 4 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Ms Lucy Parker, Imperial College London and Imperial College Healthcare NHS Trust | ||||
| Study Sponsor ICMJE | Imperial College Healthcare NHS Trust | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Imperial College Healthcare NHS Trust | ||||
| Verification Date | September 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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