Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT01196793
Status:
COMPLETED
Last Update Posted:
2019-09-17
First Post:
2010-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Hospital Admissions in Children Aged 3 Months to 5 Years Presenting With Fever to the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005334', 'term': 'Fever'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hermione.lyall@nhs.net', 'phone': '02033126965', 'title': 'Dr Hermione Lyall', 'organization': 'Imperial College London NHS Trust'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 years', 'eventGroups': [{'id': 'EG000', 'title': 'Febrile Children, Age 3 m to 5 y', 'description': '3 month to 5 years old children with febrile', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 108, 'otherNumAffected': 0, 'seriousNumAtRisk': 108, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Admission to Hospital Due to Parental High Levels of Worry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Febrile Children, Age 3 m to 5 y', 'description': '3 month to 5 years children with febrile'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7-10 days', 'description': 'Interview with the patient family to evaluation of the reasons for admission to emergency department', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Febrile Children, Age 3 m to 5 y', 'description': '3 month to 5 years old children with febrile illness'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Febrile Children, Age 3 m to 5 y', 'description': '3 month to 5 years old children with febrile illness'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '108', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2014-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-09', 'studyFirstSubmitDate': '2010-09-06', 'resultsFirstSubmitDate': '2019-07-24', 'studyFirstSubmitQcDate': '2010-09-07', 'lastUpdatePostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-24', 'studyFirstPostDateStruct': {'date': '2010-09-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Admission to Hospital Due to Parental High Levels of Worry', 'timeFrame': '7-10 days', 'description': 'Interview with the patient family to evaluation of the reasons for admission to emergency department'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Feverish illness in children'], 'conditions': ['Fever']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged 3 months to 5 years presenting to an urban paediatric emergency department with fever', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child aged 3months to 5years\n* Temperature above or equal to 38°C measured by any method or reported hot by parents\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01196793', 'briefTitle': 'Hospital Admissions in Children Aged 3 Months to 5 Years Presenting With Fever to the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College Healthcare NHS Trust'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SMH 24062010 V1 4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'febrile children, age 3 m to 5 y'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8032', 'city': 'Zurich', 'country': 'Switzerland', 'facility': "University Children's Hospital", 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': "St Mary's Hospital, Imperial NHS Hospitals Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Hermione Lyall, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College Healthcare NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College Healthcare NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}