Children With Fever and Respiratory Symptoms at Out-of-hours Services in Norway
Primary Purpose
Children
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pre-consultation CRP
Sponsored by
About this trial
This is an interventional diagnostic trial for Children focused on measuring C-reactive Protein, Primary Health Care, Child Welfare, After-Hours Care, Anti-Bacterial Agents, Drug Prescriptions
Eligibility Criteria
Inclusion Criteria:
- Children 0-6 years with fever and/or respiratory symptoms
Exclusion Criteria:
- Children older than 6 years with other conditions
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Pre-consultation CRP
CRP requested
Arm Description
Every third child included get a CRP-test before the consultation and the doctor have the answer at start of consultation
No intervention, the consultation with children as normal, the CRP is used at doctors request.
Outcomes
Primary Outcome Measures
Antibiotic prescription rate
Number of participants prescribed antibiotics
Secondary Outcome Measures
Hospitalization rate
Number of participants referred to hospital
Rate of side-effects of antibiotics
Number of participants with side-effects of antibiotics prescribed at Out-of-hours Service
Duration of illness
Number of days with fever and respiratory symptoms after the consultation at the Out-of-hours Service.
Full Information
NCT ID
NCT02496559
First Posted
June 25, 2015
Last Updated
December 2, 2015
Sponsor
NORCE Norwegian Research Centre AS
Collaborators
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02496559
Brief Title
Children With Fever and Respiratory Symptoms at Out-of-hours Services in Norway
Official Title
Children With Fever and Respiratory Symptoms at Out-of-hours Services in Norway
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Lower prevalence than expected and the inclusion was difficult.
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NORCE Norwegian Research Centre AS
Collaborators
Haukeland University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Viral self-limiting infections in respiratory organs among children are common in primary care. Serious infections have low prevalence and are challenging to distinguish from self-limiting infections.
Prescription of antibiotics in primary care is still high but stable since 2009 in Norway, and 90% of all antibiotics are prescribed in primary care.
C-reactive protein (CRP) has been especially popular in Norway for point-of-care testing in primary care, but its role in ruling-out serious infections and the cut-off value for prescribing antibiotics has been discussed a lot.
The aim of this study is to identify if pretesting with CRP of all children 0-6 year with fever or respiratory symptoms at Out-of-Hours Services will affect the prescription of antibiotics and the referral to hospital for children.
Detailed Description
Design: A randomized controlled observational study including children 0-6 year with fever and/or respiratory symptoms at 4 different Out-of-hour Services and at 1 Emergency Children Department Clinic at a hospital (open clinic). The data consist of clinical data and anamnestic information from a nurse at OOH-service collected before the consultation, the doctor's journal and a questionnaire to parents before the consultation and 1 week after the consultation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children
Keywords
C-reactive Protein, Primary Health Care, Child Welfare, After-Hours Care, Anti-Bacterial Agents, Drug Prescriptions
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
401 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-consultation CRP
Arm Type
Active Comparator
Arm Description
Every third child included get a CRP-test before the consultation and the doctor have the answer at start of consultation
Arm Title
CRP requested
Arm Type
No Intervention
Arm Description
No intervention, the consultation with children as normal, the CRP is used at doctors request.
Intervention Type
Procedure
Intervention Name(s)
Pre-consultation CRP
Intervention Description
Use of CRP test on all children with fever before the consultation (intervention) compared to where the doctor requests a CRP test (no intervention)
Primary Outcome Measure Information:
Title
Antibiotic prescription rate
Description
Number of participants prescribed antibiotics
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Hospitalization rate
Description
Number of participants referred to hospital
Time Frame
24 hours
Title
Rate of side-effects of antibiotics
Description
Number of participants with side-effects of antibiotics prescribed at Out-of-hours Service
Time Frame
7 days
Title
Duration of illness
Description
Number of days with fever and respiratory symptoms after the consultation at the Out-of-hours Service.
Time Frame
7 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children 0-6 years with fever and/or respiratory symptoms
Exclusion Criteria:
Children older than 6 years with other conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steinar Hunskår, Prof. dr.med
Organizational Affiliation
NORCE Norwegian Research Centre AS
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21266341
Citation
Brent AJ, Lakhanpaul M, Thompson M, Collier J, Ray S, Ninis N, Levin M, MacFaul R. Risk score to stratify children with suspected serious bacterial infection: observational cohort study. Arch Dis Child. 2011 Apr;96(4):361-7. doi: 10.1136/adc.2010.183111. Epub 2011 Jan 24.
Results Reference
background
PubMed Identifier
21653621
Citation
Van den Bruel A, Thompson MJ, Haj-Hassan T, Stevens R, Moll H, Lakhanpaul M, Mant D. Diagnostic value of laboratory tests in identifying serious infections in febrile children: systematic review. BMJ. 2011 Jun 8;342:d3082. doi: 10.1136/bmj.d3082.
Results Reference
background
PubMed Identifier
18026237
Citation
Nordlie AL, Andersen BM. [Changes in antibiotic consumption among day-care children in Oslo]. Tidsskr Nor Laegeforen. 2007 Nov 15;127(22):2924-6. Norwegian.
Results Reference
background
PubMed Identifier
22643151
Citation
Rebnord IK, Sandvik H, Hunskaar S. Use of laboratory tests in out-of-hours services in Norway. Scand J Prim Health Care. 2012 Jun;30(2):76-80. doi: 10.3109/02813432.2012.684208.
Results Reference
result
PubMed Identifier
22627867
Citation
Magnus MC, Vestrheim DF, Nystad W, Haberg SE, Stigum H, London SJ, Bergsaker MA, Caugant DA, Aaberge IS, Nafstad P. Decline in early childhood respiratory tract infections in the Norwegian mother and child cohort study after introduction of pneumococcal conjugate vaccination. Pediatr Infect Dis J. 2012 Sep;31(9):951-5. doi: 10.1097/INF.0b013e31825d2f76.
Results Reference
result
PubMed Identifier
28096254
Citation
Rebnord IK, Sandvik H, Mjelle AB, Hunskaar S. Factors predicting antibiotic prescription and referral to hospital for children with respiratory symptoms: secondary analysis of a randomised controlled study at out-of-hours services in primary care. BMJ Open. 2017 Jan 17;7(1):e012992. doi: 10.1136/bmjopen-2016-012992.
Results Reference
derived
PubMed Identifier
27173814
Citation
Rebnord IK, Sandvik H, Mjelle AB, Hunskaar S. Out-of-hours antibiotic prescription after screening with C reactive protein: a randomised controlled study. BMJ Open. 2016 May 12;6(5):e011231. doi: 10.1136/bmjopen-2016-011231. Erratum In: BMJ Open. 2016 Sep 09;6(9):e011231corr1.
Results Reference
derived
Links:
URL
http://uni.no/en/uni-health/national-centre-for-emergency-primary-health-care/diagnostic-equipment-at-norwegian-out-of-hours-services/
Description
Project web page
Learn more about this trial
Children With Fever and Respiratory Symptoms at Out-of-hours Services in Norway
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